Tazarotene cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis.

Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.

Tazarotene cream is for topical use only. Tazarotene cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions ( 5.2)] .

Wash hands thoroughly after application.

It is recommended that treatment starts with tazarotene cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm 2) of tazarotene cream once per day, in the evening, to cover only the psoriatic lesions. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before application of tazarotene cream. Because unaffected skin may be more susceptible to irritation, application of tazarotene cream to these areas should be carefully avoided.

Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm 2) of tazarotene cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

Use effective sunscreens and wear protective clothing while using tazarotene cream [see Warnings and Precautions ( 5.3)].

Cream, 0.05% and 0.1%. Each gram of tazarotene cream, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a white to off-white cream base.

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Tazarotene cream is contraindicated in:

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Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology ( 12.3)] .

There were thirteen reported pregnancies in subjects who participated in the clinical trials for topical tazarotene. Nine of the subjects were found to have been treated with topical tazarotene, and the other four had been treated with vehicle. One of the subjects who was treated with tazarotene cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical tazarotene during clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown.

Females of Child-bearing Potential

Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene cream is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered.

A negative result for pregnancy test should be obtained within 2 weeks prior to tazarotene cream therapy. Tazarotene cream therapy should begin during a menstrual period [see Use in Specific Populations ( 8.1)] .

Local tolerability reactions (including blistering and skin desquamation) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene. Application of tazarotene cream may cause excessive irritation in the skin of certain sensitive individuals. Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced to an interval the patient can tolerate. However, efficacy at reduced frequency of application has not been established. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate treatment.

Concomitant topical medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of tazarotene cream is begun.

Tazarotene cream, should not be used on eczematous skin, as it may cause severe irritation.

Weather extremes, such as wind or cold, may be more irritating to patients using tazarotene cream.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during the use of tazarotene cream. Patients must be warned to use sunscreens and protective clothing when using tazarotene cream. Patients with sunburn should be advised not to use tazarotene cream until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using tazarotene cream.

Tazarotene cream should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In human dermal safety trials, tazarotene cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.

Psoriasis

The most frequent adverse reactions reported with tazarotene cream, 0.05% and 0.1% occurring in 10 to 23% of subjects, in descending order, included pruritus, erythema, and burning. Reactions occurring in greater than 1 to less than 10% of subjects, in descending order, included irritation, desquamation, stinging, contact dermatitis, dermatitis, eczema, worsening of psoriasis, skin pain, rash, hypertriglyceridemia, dry skin, skin inflammation, and peripheral edema.

Tazarotene cream, 0.1% was associated with a greater degree of local irritation than the 0.05% cream. The rates of irritation adverse reactions reported during psoriasis trials with tazarotene cream, 0.1% were 0.1-0.4% higher than those reported for tazarotene cream, 0.05%.

Acne

The most frequent adverse reactions reported during clinical trials with tazarotene cream 0.1% in the treatment of acne, occurring in 10-30% of subjects, in descending order included desquamation, dry skin, erythema, and burning sensation. Reactions occurring in 1 to 5% of subjects included pruritus, irritation, face pain, and stinging.

The following adverse reactions have been identified during post approval use of tazarotene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.

No formal drug-drug interaction studies were conducted with tazarotene cream.

{ "type": "p", "children": [], "text": "No formal drug-drug interaction studies were conducted with tazarotene cream." }

In a trial of 27 healthy female subjects between the ages of 20-55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C max and AUC 0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng·hr/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

{ "type": "p", "children": [], "text": "In a trial of 27 healthy female subjects between the ages of 20-55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C\n \n max and AUC\n \n 0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng·hr/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.\n\n " }

The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

{ "type": "p", "children": [], "text": "The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated." }

Risk Summary

Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazarotene cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from tazarotene cream during pregnancy; therefore, tazarotene cream should be discontinued as soon as pregnancy is recognized [see Contraindications ( 4), Warnings and Precautions ( 5.1), Clinical Pharmacology ( 12.3)]. Limited case reports of pregnancy in females enrolled in clinical trials for tazarotene cream have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown .

In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 2 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene cream, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification. In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, there was a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.

In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 2 and 52 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays . In pregnant rats, tazarotene dosed orally prior to mating through early gestation resulted in decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations at doses approximately 7 times higher than the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% [see Data].

The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In rats, a tazarotene gel, 0.05% formulation dosed topically during gestation days 6 through 17 at 0.25 mg/kg/day, which represented 2 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% (i.e ., 2 mg/cm 2 over a 15% body surface area), resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel, which represented 26 times the maximum systemic exposure in subjects treated with MRHD of tazarotene cream, 0.1%, during gestation days 6 through 18, had a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.

When tazarotene was given orally to animals, developmental delays were seen in rats, and malformations and post-implantation loss were observed in rats and rabbits at doses representing 2 and 52 times, respectively, the maximum systemic exposure seen in subjects treated with the MRHD of tazarotene cream, 0.1%.

In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, which represented 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, classic developmental effects of retinoids were observed including decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights. A low incidence of retinoid-related malformations was observed at that dose.

In a pre-and postnatal development toxicity study, topical administration of tazarotene gel (0.125 mg/kg/day) to pregnant female rats from gestation day 16 through lactation day 20 reduced pup survival, but did not affect the reproductive capacity of the offspring. Based on data from another study, the maximum systemic exposure in the rat would be equivalent to the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%.

Risk Summary

There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of 14C-tazarotene gel to the skin of lactating rats, radioactivity was detected in rat milk. The lack of clinical data during lactation precludes a clear determination of the risk of tazarotene cream to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tazarotene cream and any potential adverse effects on the breastfed child from tazarotene cream or from the underlying maternal condition.

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating tazarotene cream therapy which should begin during a menstrual period.

Contraception

Females

Based on animal studies, tazarotene cream may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1)]. Advise females of reproductive potential to use effective contraception during treatment with tazarotene cream.

The safety and efficacy of tazarotene cream have not been established in patients with psoriasis under the age of 18 years, or in patients with acne under the age of 12 years.

Tazarotene cream for the treatment of acne has not been clinically tested in persons 65 years of age or older. Of the total number of subjects in clinical trials of tazarotene cream for plaque psoriasis, 120 were over the age of 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Currently there is no other clinical experience on the differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Excessive topical use of tazarotene cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions ( 5.2)] .

{ "type": "p", "children": [], "text": "Excessive topical use of tazarotene cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort\n \n [see Warnings and Precautions (\n \n 5.2)]\n \n .\n\n " }

Tazarotene cream, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

{ "type": "p", "children": [], "text": "Tazarotene cream, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary." }

Tazarotene cream, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a white to off-white cream base.

{ "type": "p", "children": [], "text": "Tazarotene cream, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a white to off-white cream base." }

Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C 21H 21NO 2S and molecular weight of 351.46. The structural formula is shown below:

{ "type": "p", "children": [], "text": "Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C\n \n 21H\n \n 21NO\n \n 2S and molecular weight of 351.46. The structural formula is shown below: \n \n\n" }

Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%; carbomer copolymer type A; carbomer homopolymer type B; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium hydroxide; sodium thiosulfate; and sorbitan monooleate.

{ "type": "p", "children": [], "text": "Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%; carbomer copolymer type A; carbomer homopolymer type B; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium hydroxide; sodium thiosulfate; and sorbitan monooleate." }

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα RARβ, and RAR γ, but shows relative selectivity for RARβ, and RAR γ and may modify gene expression. The clinical significance of these findings is unknown.

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly bound to plasma proteins (greater than 99%). Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways. The half-life of tazarotenic acid was approximately 18 hours, following topical application of tazarotene to normal, acne or psoriatic skin.

In a multiple dose trial with a once daily dose for 14 consecutive days in 9 psoriatic subjects (male=5; female=4), measured doses of tazarotene cream, 0.1% were applied by medical staff to involved skin without occlusion (5 to 35% of total body surface area: mean ± SD: 14 ± 11%). The C max of tazarotenic acid was 2.31 ± 2.78 ng/mL occurring 8 hours after the final dose, and the AUC 0-24h was 31.2 ± 35.2 ng·hr/mL on day 15 in the five subjects who were administered clinical doses of 2 mg cream/cm 2.

During clinical trials with tazarotene cream, 0.05% or 0.1% treatment for plaque psoriasis, three out of 139 subjects with their systemic exposure monitored had detectable plasma tazarotene concentrations, with the highest value at 0.09 ng/mL. Tazarotenic acid was detected in 78 out of 139 subjects (LLOQ = 0.05 ng/mL). Three subjects using tazarotene cream 0.1% had plasma tazarotenic acid concentrations greater than 1 ng/mL. The highest value was 2.4 ng/mL. However, because of the variations in the time of blood sampling, the area of psoriasis involvement, and the dose of tazarotene applied, actual maximal plasma levels are unknown.

Tazarotene cream 0.1% was applied once daily to either the face (N=8) or to 15% of body surface area (N=10) of female subjects with moderate to severe acne vulgaris. The mean C max and AUC values of tazarotenic acid peaked at day 15 for both dosing groups during a 29 day treatment period. Mean C max and AUC 0-24h values of tazarotenic acid from subjects in the 15% body surface area dosing group were more than 10 times higher than those from subjects in the face-only dosing group. The single highest C max throughout the trial period was 1.91 ng/mL on day 15 in the exaggerated dosing group. In the face-only group, the mean ± SD values of C max and AUC 0-24h of tazarotenic acid on day 15 were 0.10 ± 0.06 ng/mL and 1.54 ± 1.01 ng·hr/mL, respectively, whereas in the 15% body surface area dosing group, the mean ± SD values of C max and AUC 0-24h of tazarotenic acid on day 15 were 1.20 ± 0.41 ng/mL and 17.01 ± 6.15 ng·hr/mL, respectively. The steady state pharmacokinetics of tazarotenic acid had been reached by day 8 in the face-only and by day 15 in the 15% body surface area dosing groups.

In a Phase 3 clinical trial, tazarotene cream, 0.1% was applied once daily for 12 weeks to each of 48 subjects (22 females and 26 males) with facial acne vulgaris. The mean ± SD values of plasma tazarotenic acid at weeks 4 and 8 were 0.078 ± 0.073 ng/mL (N=47) and 0.052 ± 0.037 ng/mL (N=42), respectively. The highest observed individual plasma tazarotenic acid concentration was 0.41 ng/mL at week 4 from a female subject. The magnitude of plasma tazarotenic acid concentrations appears to be independent of gender, age, and body weight.

Carcinogenesis

A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in the rat equivalent to 0.6 times that seen in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/kg/cm 2 over a 35% body surface area in a controlled pharmacokinetic study. This estimated systemic exposure in rats was 2 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% cream at 2 mg/cm 2 over a 15% body surface area.

A long-term topical application study of up to 0.1% of tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals. Systemic exposures at the highest dose was 3.9 times that seen in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/cm 2 over a 35% body surface area in a controlled pharmacokinetic study, and 13 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm 2 over a 15% body surface area.

In evaluation of photo co-carcinogenicity, median time to onset of tumors was decreased, and the number of tumors increased in hairless mice following chronic topical dosing with intercurrent exposure to ultraviolet radiation at tazarotene concentrations of 0.001%, 0.005%, and 0.01% in a gel formulation for up to 40 weeks.

Mutagenesis

Tazarotene was found to be non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.

Impairment of Fertility

No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure in the rat would be equivalent to 0.6 times that observed in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/cm 2 over a 35% body surface area in a controlled pharmacokinetic study, and 2 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm 2 over a 15% body surface area.

No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene. That dose produced a systemic exposure that was 1.9 times that observed in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/cm 2 over a 35% body surface area, and 6.3 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm 2 over a 15% body surface area.

No impairment of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral doses up to 2 mg/kg/day of tazarotene. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose [see Use in Specific Populations ( 8.1)] . That dose produced a systemic exposure that was 3.4 times that observed in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/cm 2 over a 35% body surface area and 11 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm 2 over a 15% body surface area.

Reproductive capabilities of F1 animals, including F2 survival and development, were not affected by topical administration of tazarotene gel to female F0 parental rats from gestation day 16 through lactation day 20 at the maximum tolerated dose of 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure in the rat would be equivalent to 0.6 times that observed in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/cm 2 over a 35% body surface area, and 2 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm 2 over a 15% body surface area.

In two 12-week vehicle-controlled clinical trials, tazarotene cream, 0.05% and 0.1% was significantly more effective than vehicle in reducing the severity of stable plaque psoriasis. Tazarotene cream 0.1% and 0.05% demonstrated superiority over vehicle cream as early as 1 week and 2 weeks, respectively, after starting treatment.

{ "type": "p", "children": [], "text": "In two 12-week vehicle-controlled clinical trials, tazarotene cream, 0.05% and 0.1% was significantly more effective than vehicle in reducing the severity of stable plaque psoriasis. Tazarotene cream 0.1% and 0.05% demonstrated superiority over vehicle cream as early as 1 week and 2 weeks, respectively, after starting treatment." }

In these trials, the primary efficacy endpoint was “clinical success,” defined as the proportion of subjects with none, minimal, or mild overall lesional assessment at Week 12, and shown in Table 1. “Clinical success” was also significantly greater with tazarotene cream, 0.05% and 0.1% versus vehicle at most follow-up visits.

{ "type": "p", "children": [], "text": "In these trials, the primary efficacy endpoint was “clinical success,” defined as the proportion of subjects with none, minimal, or mild overall lesional assessment at Week 12, and shown in\n \n Table 1. “Clinical success” was also significantly greater with tazarotene cream, 0.05% and 0.1% versus vehicle at most follow-up visits.\n\n " }

<div class="scrollingtable"><table border="1" cellpadding="4" cellspacing="0"> <thead> <tr class="First First Last Last"> <th align="center" colspan="16">                                                         Table 1. Subject Numbers and Percentages for Overall Lesional Assessment Scores and “Clinical Success” <br/>                                                              at Baseline (BL), End of Treatment (Week 12) and 12 Weeks After Stopping Therapy (Week 24) <span class="Sup"># </span>in <br/>                                                                                                             Two Controlled Clinical Trials for Psoriasis </th> </tr> </thead> <tfoot> <tr class="First First Last Last"> <td colspan="16"> <p class="First">0  no plaque elevation above normal skin level; may have residual non-erythematous discoloration; no psoriatic scale <br/> 1  essentially flat with possible trace elevation; may have up to moderate erythema (red coloration); no psoriatic scale <br/> 2  slight but definite elevation of plaque above normal skin level; may have up to moderate erythema (red coloration); fine scales with some lesions partially covered <br/> 3  moderate elevation with rounded or sloped edges to plaque; moderate erythema (red coloration); somewhat coarser scales with most lesions partially covered <br/> 4  marked elevation with hard, sharp edges to plaque; severe erythema (very red coloration); thick scales with virtually all lesions covered and a rough surface <br/> 5  very marked elevation with very hard, sharp edges to plaque; very severe erythema (extreme red coloration); very coarse, thick scales with all lesions covered and a very rough      surface </p> <p>Clinical Success defined as an overall lesional assessment score of none, minimal, or mild.</p> <p> <span class="Bold"> #</span><span class="Bold">Trial 1 had post-treatment period observations for 12 weeks after stopping therapy, which were not part of Trial 2. </span> </p> <p> <span class="Bold">*</span><span class="Bold">Denotes statistically significant difference for "Clinical Success" compared with vehicle.</span> </p> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="5"><span class="Bold">Tazarotene Cream, 0.05%</span></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="5"><span class="Bold">Tazarotene Cream, 0.1%</span></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="5"><span class="Bold">Vehicle Cream</span></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"></td><td class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First"> <span class="Bold">Trial 1</span> </p> <p>N=218</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Trial 2</span> </p> <p>N=210</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First"> <span class="Bold">Trial 1</span> </p> <p>N=221</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Trial 2</span> </p> <p>N=211</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First"> <span class="Bold">Trial 1</span> </p> <p>N=229</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Trial 2</span> </p> <p>N=214</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Score</td><td align="center" class="Botrule Lrule Rrule Toprule">BL</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 12</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 24</td><td align="center" class="Botrule Lrule Rrule Toprule">BL</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 12</td><td align="center" class="Botrule Lrule Rrule Toprule">BL</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 12</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 24</td><td align="center" class="Botrule Lrule Rrule Toprule">BL</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 12</td><td align="center" class="Botrule Lrule Rrule Toprule">BL</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 12</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 24</td><td align="center" class="Botrule Lrule Rrule Toprule">BL</td><td align="center" class="Botrule Lrule Rrule Toprule">Wk 12</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">None (0)</td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">2 <br/> (1%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">6 <br/> (3%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.4%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.5%) </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Minimal <br/> (1) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">11 <br/> (5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">12 <br/> (6%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">7 <br/> (3%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">12 <br/> (5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">14 <br/> (6%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">11 <br/> (5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">7 <br/> (3%) </td><td align="center" class="Botrule Lrule Rrule Toprule">6 <br/> (3%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.5%) </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Mild <br/> (2) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">79 <br/> (36%) </td><td align="center" class="Botrule Lrule Rrule Toprule">60 <br/> (28%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">76 <br/> (36%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">75 <br/> (34%) </td><td align="center" class="Botrule Lrule Rrule Toprule">53 <br/> (24%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">90 <br/> (43%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">49 <br/> (21%) </td><td align="center" class="Botrule Lrule Rrule Toprule">43 <br/> (19%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">54 <br/> (25%) </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Moderate <br/> (3) </td><td align="center" class="Botrule Lrule Rrule Toprule">141 <br/> (65%) </td><td align="center" class="Botrule Lrule Rrule Toprule">86 <br/> (39%) </td><td align="center" class="Botrule Lrule Rrule Toprule">90 <br/> (41%) </td><td align="center" class="Botrule Lrule Rrule Toprule">100 <br/> (48%) </td><td align="center" class="Botrule Lrule Rrule Toprule">74 <br/> (35%) </td><td align="center" class="Botrule Lrule Rrule Toprule">122 <br/> (55%) </td><td align="center" class="Botrule Lrule Rrule Toprule">97 <br/> (44%) </td><td align="center" class="Botrule Lrule Rrule Toprule">107 <br/> (48%) </td><td align="center" class="Botrule Lrule Rrule Toprule">96 <br/> (45%) </td><td align="center" class="Botrule Lrule Rrule Toprule">62 <br/> (29%) </td><td align="center" class="Botrule Lrule Rrule Toprule">139 <br/> (61%) </td><td align="center" class="Botrule Lrule Rrule Toprule">119 <br/> (52%) </td><td align="center" class="Botrule Lrule Rrule Toprule">114 <br/> (50%) </td><td align="center" class="Botrule Lrule Rrule Toprule">97 <br/> (45%) </td><td align="center" class="Botrule Lrule Rrule Toprule">99 <br/> (46%) </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Severe <br/> (4) </td><td align="center" class="Botrule Lrule Rrule Toprule">69 <br/> (32%) </td><td align="center" class="Botrule Lrule Rrule Toprule">39 <br/> (18%) </td><td align="center" class="Botrule Lrule Rrule Toprule">51 <br/> (23%) </td><td align="center" class="Botrule Lrule Rrule Toprule">80 <br/> (38%) </td><td align="center" class="Botrule Lrule Rrule Toprule">36 <br/> (17%) </td><td align="center" class="Botrule Lrule Rrule Toprule">91 <br/> (41%) </td><td align="center" class="Botrule Lrule Rrule Toprule">36 <br/> (16%) </td><td align="center" class="Botrule Lrule Rrule Toprule">46 <br/> (21%) </td><td align="center" class="Botrule Lrule Rrule Toprule">86 <br/> (41%) </td><td align="center" class="Botrule Lrule Rrule Toprule">29 <br/> (14%) </td><td align="center" class="Botrule Lrule Rrule Toprule">81 <br/> (35%) </td><td align="center" class="Botrule Lrule Rrule Toprule">51 <br/> (22%) </td><td align="center" class="Botrule Lrule Rrule Toprule">61 <br/> (27%) </td><td align="center" class="Botrule Lrule Rrule Toprule">93 <br/> (44%) </td><td align="center" class="Botrule Lrule Rrule Toprule">47 <br/> (22%) </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Very <br/> Severe <br/> (5) </td><td align="center" class="Botrule Lrule Rrule Toprule">8 <br/> (4%) </td><td align="center" class="Botrule Lrule Rrule Toprule">2 <br/> (0.9%) </td><td align="center" class="Botrule Lrule Rrule Toprule">4 <br/> (2%) </td><td align="center" class="Botrule Lrule Rrule Toprule">30 <br/> (14%) </td><td align="center" class="Botrule Lrule Rrule Toprule">15 <br/> (7%) </td><td align="center" class="Botrule Lrule Rrule Toprule">8 <br/> (4%) </td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">1 <br/> (0.5%) </td><td align="center" class="Botrule Lrule Rrule Toprule">29 <br/> (14%) </td><td align="center" class="Botrule Lrule Rrule Toprule">13 <br/> (6%) </td><td align="center" class="Botrule Lrule Rrule Toprule">9 <br/> (4%) </td><td align="center" class="Botrule Lrule Rrule Toprule">3 <br/> (1%) </td><td align="center" class="Botrule Lrule Rrule Toprule">4 <br/> (2%) </td><td align="center" class="Botrule Lrule Rrule Toprule">24 <br/> (11%) </td><td align="center" class="Botrule Lrule Rrule Toprule">12 <br/> (6%) </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule">"Clinical <br/> Success" </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">91 <br/> (42%*) </td><td align="center" class="Botrule Lrule Rrule Toprule">73 <br/> (33%*) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">85 <br/> (40%*) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">87 <br/> (39%*) </td><td align="center" class="Botrule Lrule Rrule Toprule">67 <br/> (30%*) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">107 <br/> (51%*) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">56 <br/> (24%) </td><td align="center" class="Botrule Lrule Rrule Toprule">50 <br/> (22%) </td><td align="center" class="Botrule Lrule Rrule Toprule">0</td><td align="center" class="Botrule Lrule Rrule Toprule">56 <br/> (26%) </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"4\" cellspacing=\"0\">\n<thead>\n<tr class=\"First First Last Last\">\n<th align=\"center\" colspan=\"16\">                                                         Table 1. Subject Numbers and Percentages for Overall Lesional Assessment Scores and “Clinical Success” \n <br/>                                                              at Baseline (BL), End of Treatment (Week 12) and 12 Weeks After Stopping Therapy (Week 24)\n \n <span class=\"Sup\"># </span>in \n <br/>                                                                                                             Two Controlled Clinical Trials for Psoriasis\n \n </th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First First Last Last\">\n<td colspan=\"16\">\n<p class=\"First\">0  no plaque elevation above normal skin level; may have residual non-erythematous discoloration; no psoriatic scale \n <br/> 1  essentially flat with possible trace elevation; may have up to moderate erythema (red coloration); no psoriatic scale \n <br/> 2  slight but definite elevation of plaque above normal skin level; may have up to moderate erythema (red coloration); fine scales with some lesions partially covered \n <br/> 3  moderate elevation with rounded or sloped edges to plaque; moderate erythema (red coloration); somewhat coarser scales with most lesions partially covered \n <br/> 4  marked elevation with hard, sharp edges to plaque; severe erythema (very red coloration); thick scales with virtually all lesions covered and a rough surface \n <br/> 5  very marked elevation with very hard, sharp edges to plaque; very severe erythema (extreme red coloration); very coarse, thick scales with all lesions covered and a very rough      surface\n </p>\n<p>Clinical Success defined as an overall lesional assessment score of none, minimal, or mild.</p>\n<p>\n<span class=\"Bold\"> #</span><span class=\"Bold\">Trial 1 had post-treatment period observations for 12 weeks after stopping therapy, which were not part of Trial 2. </span>\n</p>\n<p>\n<span class=\"Bold\">*</span><span class=\"Bold\">Denotes statistically significant difference for \"Clinical Success\" compared with vehicle.</span>\n</p>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"5\"><span class=\"Bold\">Tazarotene Cream, 0.05%</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"5\"><span class=\"Bold\">Tazarotene Cream, 0.1%</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"5\"><span class=\"Bold\">Vehicle Cream</span></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\"></td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 1</span>\n</p>\n<p>N=218</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 2</span>\n</p>\n<p>N=210</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 1</span>\n</p>\n<p>N=221</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 2</span>\n</p>\n<p>N=211</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 1</span>\n</p>\n<p>N=229</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 2</span>\n</p>\n<p>N=214</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Score</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">BL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 12</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 24</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">BL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 12</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">BL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 12</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 24</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">BL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 12</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">BL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 12</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 24</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">BL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Wk 12</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">None (0)</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">2 \n <br/> (1%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">6 \n <br/> (3%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.4%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.5%)\n </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Minimal \n <br/> (1)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">11 \n <br/> (5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">12 \n <br/> (6%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">7 \n <br/> (3%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">12 \n <br/> (5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">14 \n <br/> (6%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">11 \n <br/> (5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">7 \n <br/> (3%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">6 \n <br/> (3%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.5%)\n </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Mild \n <br/> (2)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">79 \n <br/> (36%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">60 \n <br/> (28%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">76 \n <br/> (36%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">75 \n <br/> (34%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">53 \n <br/> (24%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">90 \n <br/> (43%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">49 \n <br/> (21%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">43 \n <br/> (19%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">54 \n <br/> (25%)\n </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Moderate \n <br/> (3)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">141 \n <br/> (65%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">86 \n <br/> (39%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">90 \n <br/> (41%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">100 \n <br/> (48%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">74 \n <br/> (35%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">122 \n <br/> (55%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">97 \n <br/> (44%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">107 \n <br/> (48%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">96 \n <br/> (45%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">62 \n <br/> (29%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">139 \n <br/> (61%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">119 \n <br/> (52%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">114 \n <br/> (50%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">97 \n <br/> (45%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">99 \n <br/> (46%)\n </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Severe \n <br/> (4)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">69 \n <br/> (32%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">39 \n <br/> (18%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">51 \n <br/> (23%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">80 \n <br/> (38%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">36 \n <br/> (17%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">91 \n <br/> (41%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">36 \n <br/> (16%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">46 \n <br/> (21%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">86 \n <br/> (41%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">29 \n <br/> (14%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">81 \n <br/> (35%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">51 \n <br/> (22%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">61 \n <br/> (27%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">93 \n <br/> (44%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">47 \n <br/> (22%)\n </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Very \n <br/> Severe \n <br/> (5)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">8 \n <br/> (4%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">2 \n <br/> (0.9%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">4 \n <br/> (2%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">30 \n <br/> (14%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">15 \n <br/> (7%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">8 \n <br/> (4%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1 \n <br/> (0.5%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">29 \n <br/> (14%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">13 \n <br/> (6%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">9 \n <br/> (4%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3 \n <br/> (1%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">4 \n <br/> (2%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">24 \n <br/> (11%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">12 \n <br/> (6%)\n </td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\"Clinical \n <br/> Success\"\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">91 \n <br/> (42%*)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">73 \n <br/> (33%*)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">85 \n <br/> (40%*)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">87 \n <br/> (39%*)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">67 \n <br/> (30%*)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">107 \n <br/> (51%*)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">56 \n <br/> (24%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">50 \n <br/> (22%)\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">56 \n <br/> (26%)\n </td>\n</tr>\n</tbody>\n</table></div>" }

At the end of 12 weeks of treatment, tazarotene cream, 0.05% and 0.1% was consistently superior to vehicle in reducing the plaque thickness of psoriasis. Improvements in erythema and scaling were generally significantly greater with tazarotene cream, 0.05% and 0.1% than with vehicle. Tazarotene cream, 0.1% was also generally more effective than tazarotene cream, 0.05% in reducing the severity of the individual signs of disease. However, tazarotene cream, 0.1% was associated with a greater degree of local irritation than tazarotene cream, 0.05%

{ "type": "p", "children": [], "text": "At the end of 12 weeks of treatment, tazarotene cream, 0.05% and 0.1% was consistently superior to vehicle in reducing the plaque thickness of psoriasis. Improvements in erythema and scaling were generally significantly greater with tazarotene cream, 0.05% and 0.1% than with vehicle. Tazarotene cream, 0.1% was also generally more effective than tazarotene cream, 0.05% in reducing the severity of the individual signs of disease. However, tazarotene cream, 0.1% was associated with a greater degree of local irritation than tazarotene cream, 0.05%" }

<div class="scrollingtable"><table cellpadding="0" cellspacing="0" width="735px"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" colspan="20" valign="top"> <p class="First"> <span class="Bold">                  Table 2. Mean Decreases in Plaque Elevation, Scaling and Erythema in Two Controlled Clinical Trials for Psoriasis</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"></td><td class="Botrule Lrule Rrule Toprule" colspan="6" valign="top"> <p class="First"> <span class="Bold">         Tazarotene Cream, 0.05%</span> </p> </td><td class="Botrule Lrule Rrule Toprule" colspan="6" valign="top"> <p class="First"> <span class="Bold">         Tazarotene Cream, 0.1%</span> </p> </td><td class="Botrule Lrule Rrule Toprule" colspan="6" valign="top"> <p class="First"> <span class="Bold">                     Vehicle Cream</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"></p> <p>Lesion</p> <p></p> <p></p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">  Trunk/Arm/    Leg lesions</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> Knee/Elbow      lesions</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">  All Treated</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">  Trunk/Arm/    Leg lesions</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> Knee/Elbow      lesions</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">   All Treated</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> Trunk/Arm/    Leg lesions</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> Knee/Elbow       lesions</p> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">  All Treated</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" rowspan="2" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Trial 2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=218</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=210</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=218</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=210</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=218</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=210</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=221</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=211</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=221</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=211</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=221</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=211</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=229</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=214</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=229</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=214</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=229</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">N=214</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Plaque</p> <p>elevation    </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">    B#   </span> </p> <p>C-12</p> <p>C-24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.29</span></span> </p> <p>-0.83*</p> <p>-0.75*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.50</span></span> </p> <p>-0.98*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.40</span></span> </p> <p>-0.91*</p> <p>-0.73*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.52</span></span> </p> <p>-1.04*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.28</span></span> </p> <p>-0.75*</p> <p>-0.60*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-0.90*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.34</span></span> </p> <p>-1.08*</p> <p>-0.87*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.52</span></span> </p> <p>-1.25*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.35</span></span> </p> <p>-0.96*</p> <p>-0.73*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.49</span></span> </p> <p>-1.21*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.32</span></span> </p> <p>-0.83*</p> <p>-0.63*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-1.08*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.28</span></span> </p> <p> <span class="Bold">-</span>0.59 </p> <p>-0.57</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-0.69</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.35</span></span> </p> <p> <span class="Bold">-</span>0.57 </p> <p>-0.49</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-0.68</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.29</span></span> </p> <p> <span class="Bold">-</span>0.48 </p> <p>-0.42</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-0.61</p> <p></p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Scaling</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">B#</span> </p> <p>C-12</p> <p>C-24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.26</span></span> </p> <p> <span class="Bold">-</span>0.75 </p> <p>-0.68</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.45</span></span> </p> <p>-0.90</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.47</span></span> </p> <p>-0.78*</p> <p>-0.62*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.60</span></span> </p> <p>-0.98*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.32</span></span> </p> <p>-0.67*</p> <p>-0.51*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.47</span></span> </p> <p>-0.80</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.37</span></span> </p> <p>-0.84*</p> <p>-0.79*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.45</span></span> </p> <p>-1.06*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.40</span></span> </p> <p>-0.76*</p> <p>-0.61*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.57</span></span> </p> <p>-1.13*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.36</span></span> </p> <p>-0.73*</p> <p>-0.59*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.53</span></span> </p> <p>-1.03*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.34</span></span> </p> <p> <span class="Bold">-</span>0.66 </p> <p>-0.56</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.46</span></span> </p> <p>-0.79</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.45</span></span> </p> <p> <span class="Bold">-</span>0.62 </p> <p>-0.45</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.61</span></span> </p> <p>-0.76</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.31</span></span> </p> <p> <span class="Bold">-</span>0.46 </p> <p>-0.34</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.53</span></span> </p> <p>-0.70</p> <p></p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Erythema </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">B#</span> </p> <p>C-12</p> <p>C-24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.26</span></span> </p> <p> <span class="Bold">-</span>0.49 </p> <p>-0.52</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-0.65*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.17</span></span> </p> <p> <span class="Bold">-</span>0.44 </p> <p>  -0.44</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.40</span></span> </p> <p>-0.66*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.23</span></span> </p> <p> <span class="Bold">-</span>0.40 </p> <p>-0.41</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.48</span></span> </p> <p>-0.62</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.25</span></span> </p> <p> <span class="Bold">-</span>0.49 </p> <p>  -0.55</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.53</span></span> </p> <p>-0.82*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.17</span></span> </p> <p>-0.57*</p> <p>-0.52*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.42</span></span> </p> <p>-0.82*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.21</span></span> </p> <p>-0.42*</p> <p>-0.39*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.51</span></span> </p> <p>-0.78*</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.24</span></span> </p> <p> <span class="Bold">-</span>0.42 </p> <p>-0.43</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.47</span></span> </p> <p>-0.46</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.17</span></span> </p> <p> <span class="Bold">-</span>0.38 </p> <p>-0.34</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.34</span></span> </p> <p>-0.44</p> <p></p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.24</span></span> </p> <p> <span class="Bold">-</span>0.37 </p> <p>-0.33</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"><span class="Underline">2.47</span></span> </p> <p>-0.47</p> <p></p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="20" valign="top"> <p class="First">Plaque elevation, scaling and erythema scored on a 0-4 scale with 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.</p> <p>B#=Mean Baseline Severity; <br/> C-12=Mean Change from Baseline at end of 12 weeks of therapy; <br/> C-24=Mean Change from Baseline at week 24 (12 weeks after the end of therapy). <br/> <span class="Bold">* Denotes statistically significant difference compared with vehicle.</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"0\" cellspacing=\"0\" width=\"735px\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"20\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">                  Table 2. Mean Decreases in Plaque Elevation, Scaling and Erythema in Two Controlled Clinical Trials for Psoriasis</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"6\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">         Tazarotene Cream, 0.05%</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"6\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">         Tazarotene Cream, 0.1%</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"6\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">                     Vehicle Cream</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\"></p>\n<p>Lesion</p>\n<p></p>\n<p></p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">  Trunk/Arm/    Leg lesions</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\"> Knee/Elbow      lesions</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">  All Treated</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">  Trunk/Arm/    Leg lesions</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\"> Knee/Elbow      lesions</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">   All Treated</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\"> Trunk/Arm/    Leg lesions</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\"> Knee/Elbow       lesions</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">  All Treated</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" rowspan=\"2\" valign=\"top\"></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 1</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Trial 2</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=218</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=210</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=218</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=210</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=218</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=210</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=221</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=211</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=221</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=211</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=221</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=211</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=229</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=214</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=229</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=214</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=229</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">N=214</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Plaque</p>\n<p>elevation    </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">    B#   </span>\n</p>\n<p>C-12</p>\n<p>C-24</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.29</span></span>\n</p>\n<p>-0.83*</p>\n<p>-0.75*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.50</span></span>\n</p>\n<p>-0.98*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.40</span></span>\n</p>\n<p>-0.91*</p>\n<p>-0.73*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.52</span></span>\n</p>\n<p>-1.04*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.28</span></span>\n</p>\n<p>-0.75*</p>\n<p>-0.60*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-0.90*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.34</span></span>\n</p>\n<p>-1.08*</p>\n<p>-0.87*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.52</span></span>\n</p>\n<p>-1.25*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.35</span></span>\n</p>\n<p>-0.96*</p>\n<p>-0.73*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.49</span></span>\n</p>\n<p>-1.21*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.32</span></span>\n</p>\n<p>-0.83*</p>\n<p>-0.63*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-1.08*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.28</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.59\n \n </p>\n<p>-0.57</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-0.69</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.35</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.57\n \n </p>\n<p>-0.49</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-0.68</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.29</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.48\n \n </p>\n<p>-0.42</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-0.61</p>\n<p></p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Scaling</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">B#</span>\n</p>\n<p>C-12</p>\n<p>C-24</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.26</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.75\n \n </p>\n<p>-0.68</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.45</span></span>\n</p>\n<p>-0.90</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.47</span></span>\n</p>\n<p>-0.78*</p>\n<p>-0.62*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.60</span></span>\n</p>\n<p>-0.98*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.32</span></span>\n</p>\n<p>-0.67*</p>\n<p>-0.51*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.47</span></span>\n</p>\n<p>-0.80</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.37</span></span>\n</p>\n<p>-0.84*</p>\n<p>-0.79*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.45</span></span>\n</p>\n<p>-1.06*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.40</span></span>\n</p>\n<p>-0.76*</p>\n<p>-0.61*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.57</span></span>\n</p>\n<p>-1.13*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.36</span></span>\n</p>\n<p>-0.73*</p>\n<p>-0.59*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.53</span></span>\n</p>\n<p>-1.03*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.34</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.66\n \n </p>\n<p>-0.56</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.46</span></span>\n</p>\n<p>-0.79</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.45</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.62\n \n </p>\n<p>-0.45</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.61</span></span>\n</p>\n<p>-0.76</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.31</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.46\n \n </p>\n<p>-0.34</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.53</span></span>\n</p>\n<p>-0.70</p>\n<p></p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Erythema </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">B#</span>\n</p>\n<p>C-12</p>\n<p>C-24</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.26</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.49\n \n </p>\n<p>-0.52</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-0.65*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.17</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.44\n \n </p>\n<p>  -0.44</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.40</span></span>\n</p>\n<p>-0.66*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.23</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.40\n \n </p>\n<p>-0.41</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.48</span></span>\n</p>\n<p>-0.62</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.25</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.49\n \n </p>\n<p>  -0.55</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.53</span></span>\n</p>\n<p>-0.82*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.17</span></span>\n</p>\n<p>-0.57*</p>\n<p>-0.52*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.42</span></span>\n</p>\n<p>-0.82*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.21</span></span>\n</p>\n<p>-0.42*</p>\n<p>-0.39*</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.51</span></span>\n</p>\n<p>-0.78*</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.24</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.42\n \n </p>\n<p>-0.43</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.47</span></span>\n</p>\n<p>-0.46</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.17</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.38\n \n </p>\n<p>-0.34</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.34</span></span>\n</p>\n<p>-0.44</p>\n<p></p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.24</span></span>\n</p>\n<p>\n<span class=\"Bold\">-</span>0.37\n \n </p>\n<p>-0.33</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><span class=\"Underline\">2.47</span></span>\n</p>\n<p>-0.47</p>\n<p></p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"20\" valign=\"top\">\n<p class=\"First\">Plaque elevation, scaling and erythema scored on a 0-4 scale with 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.</p>\n<p>B#=Mean Baseline Severity; \n <br/> C-12=Mean Change from Baseline at end of 12 weeks of therapy; \n <br/> C-24=Mean Change from Baseline at week 24 (12 weeks after the end of therapy). \n <br/>\n<span class=\"Bold\">* Denotes statistically significant difference compared with vehicle.</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Acne:

{ "type": "p", "children": [], "text": "\nAcne:\n" }

In two large vehicle-controlled trials, subjects age 12 years and over with facial acne vulgaris of a severity suitable for monotherapy with a topical agent were enrolled. After face cleansing in the evening, tazarotene cream, 0.1% was applied once daily to the entire face as a thin layer. Tazarotene cream, 0.1% was significantly more effective than vehicle in the treatment of facial acne vulgaris. Efficacy results after 12 weeks of treatment are shown in Table 3:

{ "type": "p", "children": [], "text": "In two large vehicle-controlled trials, subjects age 12 years and over with facial acne vulgaris of a severity suitable for monotherapy with a topical agent were enrolled. After face cleansing in the evening, tazarotene cream, 0.1% was applied once daily to the entire face as a thin layer. Tazarotene cream, 0.1% was significantly more effective than vehicle in the treatment of facial acne vulgaris. Efficacy results after 12 weeks of treatment are shown in\n \n Table 3:\n\n " }

<div class="scrollingtable"><table border="1" cellpadding="4"> <thead> <tr class="First First Last Last"> <th colspan="5">Table 3. Efficacy Results after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne</th> </tr> </thead> <tfoot> <tr class="First First Last Last"> <td colspan="5"><span class="Bold">* Denotes statistically significant difference compared with vehicle.</span></td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" rowspan="2"></td><td class="Botrule Lrule Rrule Toprule" colspan="2"><span class="Bold">Tazarotene Cream, 0.1%</span></td><td class="Botrule Lrule Rrule Toprule" colspan="2"><span class="Bold">Vehicle Cream</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Trial 1</span> <br/> N=218 </td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Trial 2</span> <br/> N=206 </td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Trial 1</span> <br/> N=218 </td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Trial 2</span> <br/> N=205 </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule">Median Percent Reduction in <br/> <br/> ●  Noninflammatory lesions <br/> <br/> ●  Inflammatory lesions <br/> <br/> ●  Total lesions </td><td align="center" class="Botrule Lrule Rrule Toprule"> <br/> <br/> 46%* <br/> <br/> 41%* <br/> <br/> 44%* </td><td align="center" class="Botrule Lrule Rrule Toprule"> <br/> <br/> 41%* <br/> <br/> 44%* <br/> <br/> 42%* </td><td align="center" class="Botrule Lrule Rrule Toprule"> <br/> <br/> 27% <br/> <br/> 27% <br/> <br/> 24% </td><td align="center" class="Botrule Lrule Rrule Toprule"> <br/> <br/> 21% <br/> <br/> 25% <br/> <br/> 21% </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule">Percent of Subjects with No Acne or Minimal Acne</td><td align="center" class="Botrule Lrule Rrule Toprule">18%*</td><td align="center" class="Botrule Lrule Rrule Toprule">20%*</td><td align="center" class="Botrule Lrule Rrule Toprule">11%</td><td align="center" class="Botrule Lrule Rrule Toprule">6%</td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule">Percent of Subjects with No Acne, Minimal Acne, or Mild Acne</td><td align="center" class="Botrule Lrule Rrule Toprule">55%*</td><td align="center" class="Botrule Lrule Rrule Toprule">53%*</td><td align="center" class="Botrule Lrule Rrule Toprule">36%</td><td align="center" class="Botrule Lrule Rrule Toprule">36%</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"4\">\n<thead>\n<tr class=\"First First Last Last\">\n<th colspan=\"5\">Table 3. Efficacy Results after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First First Last Last\">\n<td colspan=\"5\"><span class=\"Bold\">* Denotes statistically significant difference compared with vehicle.</span></td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\"></td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Tazarotene Cream, 0.1%</span></td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Vehicle Cream</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Trial 1</span>\n<br/> N=218\n \n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Trial 2</span>\n<br/> N=206\n \n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Trial 1</span>\n<br/> N=218\n \n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Trial 2</span>\n<br/> N=205\n \n </td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">Median Percent Reduction in \n <br/>\n<br/> ●  Noninflammatory lesions \n <br/>\n<br/> ●  Inflammatory lesions \n <br/>\n<br/> ●  Total lesions\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<br/>\n<br/> 46%* \n <br/>\n<br/> 41%* \n <br/>\n<br/> 44%*\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<br/>\n<br/> 41%* \n <br/>\n<br/> 44%* \n <br/>\n<br/> 42%*\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<br/>\n<br/> 27% \n <br/>\n<br/> 27% \n <br/>\n<br/> 24%\n </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<br/>\n<br/> 21% \n <br/>\n<br/> 25% \n <br/>\n<br/> 21%\n </td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">Percent of Subjects with No Acne or Minimal Acne</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">18%*</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">20%*</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">11%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">6%</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\">Percent of Subjects with No Acne, Minimal Acne, or Mild Acne</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">55%*</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">53%*</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">36%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">36%</td>\n</tr>\n</tbody>\n</table></div>" }

Tazarotene cream is a white to off-white cream available in concentrations of 0.05% and 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in 30 g and 60 g sizes.

{ "type": "p", "children": [], "text": "Tazarotene cream is a white to off-white cream available in concentrations of 0.05% and 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in 30 g and 60 g sizes." }

             Tazarotene Cream, 0.05%                   Tazarotene Cream, 0.1% 30 g       NDC 0713-0765-31                             NDC 0713-0670-31 60 g       NDC 0713-0765-60                             NDC 0713-0670-60

{ "type": "p", "children": [], "text": "             Tazarotene Cream, 0.05%                   Tazarotene Cream, 0.1% \n 30 g       NDC 0713-0765-31                             NDC 0713-0670-31 \n 60 g       NDC 0713-0765-60                             NDC 0713-0670-60\n " }

Storage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from -5°C to 30°C (23°F to 86°F).

{ "type": "p", "children": [], "text": "\nStorage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from -5°C to 30°C (23°F to 86°F).\n\n " }

Advise the patient to read the FDA-approved patient labeling ( Patient Information).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (\n \n Patient Information).\n\n " }

Embryofetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryofetal Toxicity\n" }

Inform females of reproductive potential of the potential risk to a fetus. Advise these patients to use effective contraception during treatment with tazarotene cream. Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.1, 8.3)] .

{ "type": "p", "children": [], "text": "\nInform females of reproductive potential of the potential risk to a fetus. Advise these patients to use effective contraception during treatment with tazarotene cream. Advise patients to inform their healthcare provider of a known or suspected pregnancy\n \n [see Warnings and Precautions (\n \n 5.1)\n \n and\n \n Use in Specific Populations (\n \n 8.1,\n \n 8.3)]\n \n .\n\n " }

Photosensitivity and Risk of Sunburn

{ "type": "p", "children": [], "text": "\nPhotosensitivity and Risk of Sunburn\n" }

Advise patients to avoid excessive sun exposure and to use of sunscreens and protective measures (hat, visor). Advise patients to avoid using tazarotene if also taking other medicines may increase sensitivity to sunlight.

{ "type": "p", "children": [], "text": "\nAdvise patients to avoid excessive sun exposure and to use of sunscreens and protective measures (hat, visor). Advise patients to avoid using tazarotene if also taking other medicines may increase sensitivity to sunlight.\n\n " }

Important Administration Instructions

{ "type": "p", "children": [], "text": "\nImportant Administration Instructions\n" }

Advise the patient of the following:

{ "type": "p", "children": [], "text": "\nAdvise the patient of the following:\n\n " }

{ "type": "", "children": [], "text": "" }

Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080

{ "type": "p", "children": [], "text": "\nDistributed by:\n Cosette Pharmaceuticals, Inc. \n South Plainfield, NJ 07080\n\n " }

Revised: 12/2023 8-TAZCPLNC1     VC7727

{ "type": "p", "children": [], "text": "Revised: 12/2023 \n 8-TAZCPLNC1     VC7727\n " }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="45%"/> <col align="left" valign="top" width="55%"/> <thead> <tr class="First First Last Last"> <th align="center" class="Lrule Rrule" colspan="2">Patient Information <br/> TAZAROTENE (taz-AR-oh-teen) <br/> Cream, 0.05% and 0.1% </th> </tr> </thead> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="2">This Patient Information has been approved by the U.S. Food and Drug Administration.                                       Revised: 12/2023                   </td> </tr> </tfoot> <tbody> <tr class="Botrule First First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Important information</span>: Tazarotene cream is for use on skin only. Do not use tazarotene cream in your eyes, mouth, or vagina. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What is the most important information I should know about tazarotene cream? <br/> Tazarotene cream may cause birth defects if used during pregnancy. </span> <ul class="Disc"> <li> <span class="Bold">Females must not be pregnant when they start using tazarotene cream or become pregnant during treatment with tazarotene cream.</span> </li> <li>For females who are able to get pregnant: <ul class="Circle"> <li>Your doctor will order a pregnancy test for you within 2 weeks before you begin treatment with tazarotene cream to be sure that you are not pregnant. Your doctor will decide when to do the test.</li> <li>Begin treatment with tazarotene cream during a normal menstrual period.</li> <li>Use an effective form of birth control during treatment with tazarotene cream. Talk with your doctor about birth control options that may be used to prevent pregnancy during treatment with tazarotene cream.</li> <li> <span class="Bold">Stop using tazarotene cream and tell your doctor right away if you become pregnant while using tazarotene cream.</span> </li> </ul> </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What is tazarotene cream?</span> <ul class="Disc"> <li>Tazarotene cream 0.05% and 0.1% is a prescription medicine used on the skin (topical) to treat people with plaque psoriasis.</li> <li>Tazarotene cream 0.1% is also used on the skin to treat people with acne vulgaris.</li> <li>It is not known if tazarotene cream is safe and effective for: <ul class="Circle"> <li>the treatment of plaque psoriasis in children under 18 years of age</li> <li>the treatment of acne vulgaris in children under 12 years of age</li> </ul> </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Who should not use tazarotene cream? <br/> Do not use tazarotene cream if you: </span> <ul class="Disc"> <li>are pregnant or plan to become pregnant. See " <span class="Bold"><a href="#Important">What is the most important information I should know about tazarotene cream?</a></span>" at the beginning of this leaflet. </li> <li>are allergic to tazarotene or any of the ingredients in tazarotene cream. See the end of this leaflet for a complete list of ingredients in tazarotene cream.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What should I tell my doctor before using tazarotene cream? <br/> Before you use tazarotene cream, tell your doctor about all of your medical conditions, including if you: </span> <ul class="Disc"> <li>have eczema or any other skin problems</li> <li>are breastfeeding or plan to breastfeed. It is not known if tazarotene cream passes into your breast milk. Talk to your doctor about using tazarotene cream while breastfeeding.</li> </ul>Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> <span class="Bold">Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight</span>. <br/> Also, tell your doctor about any cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How should I use tazarotene cream?</span> <ul class="Disc"> <li>Use tazarotene cream exactly as your doctor tells you to use it.</li> <li>Apply tazarotene cream 1 time each day, in the evening.</li> <li> <span class="Bold">Do not</span>get tazarotene cream in your eyes, on your eyelids, or in your mouth. If tazarotene cream gets in or near your eyes, rinse them well with water. Call your doctor or get medical help if you have eye irritation that does not go away. </li> <li>Wash your hands after applying tazarotene cream.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Follow these instructions for applying tazarotene cream:</span> <ul class="Disc"> <li> <span class="Bold">If you have psoriasis:</span> <ul class="Circle"> <li>If you shower or bathe before applying tazarotene cream, your skin should be dry before applying the cream.</li> <li>You may use a cream or lotion to soften or moisten your skin at least 1 hour before you apply tazarotene cream.</li> <li>Apply a thin layer of tazarotene cream to cover only the psoriasis lesions.</li> </ul> </li> <li> <span class="Bold">If you have acne:</span> <ul class="Circle"> <li>Gently wash and dry your face before applying tazarotene cream.</li> <li>Apply a thin layer of tazarotene cream to cover only the acne lesions.</li> </ul> </li> <li>If you swallow tazarotene cream, call your doctor or go to the nearest hospital emergency room right away.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What should I avoid while using tazarotene cream?</span> <ul class="Disc"> <li>Avoid sunlight, including sunlamps, during treatment with tazarotene cream. Tazarotene cream can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.</li> <li>Talk to your doctor if you get a sunburn during treatment with tazarotene cream. If you get a sunburn, do not use tazarotene cream until your sunburn is healed.</li> <li>Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry.</li> <li>Avoid using tazarotene cream on unaffected skin or skin with eczema because it may cause severe irritation.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the possible side effects of tazarotene cream? <br/> Tazarotene cream may cause serious side effects, including: </span> <ul class="Disc"> <li> <span class="Bold">Skin irritation and allergic reactions (hypersensitivity).</span>Tazarotene cream may cause increased skin irritation and hives. Tell your doctor if you develop hives, or itching, burning, redness, or peeling of your skin during treatment with tazarotene cream. If you develop hives or skin irritation, your doctor may tell you to stop using tazarotene cream until your skin heals, tell you to use tazarotene cream less often, or change your tazarotene cream dose. Also, wind or cold weather may be more irritating to your skin while you are using tazarotene cream. </li> <li> <span class="Bold">Sensitivity to sunlight and risk of sunburn.</span>See " <span class="Bold"><a href="#Avoid">What should I avoid while using tazarotene cream?</a></span>" </li> </ul> <span class="Bold">The most common side effects of tazarotene cream in people with psoriasis include</span>itching, redness and burning. <br/> <span class="Bold">The most common side effects of tazarotene cream in people with acne include</span>peeling, dry skin, redness and burning. These are not all the possible side effects of tazarotene cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How should I store tazarotene cream?</span> <ul class="Disc"> <li>Store tazarotene cream at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>Keep tazarotene cream and all medicines out of the reach of children.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of tazarotene cream.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tazarotene cream for a condition for which it was not prescribed. Do not give tazarotene cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about tazarotene cream that is written for health professionals. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in tazarotene cream? <br/> Active ingredient: </span>tazarotene <br/> <span class="Bold">Inactive ingredients:</span> benzyl alcohol 1%, carbomer copolymer type A, carbomer homopolymer type B, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium hydroxide, sodium thiosulfate, and sorbitan monooleate </td> </tr> <tr class="Botrule Last Last"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Distributed by:</span> <br/> Cosette Pharmaceuticals, Inc.             8-TAZCPLNC1 <br/> South Plainfield, NJ 07080                   VC7727 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"45%\"/>\n<col align=\"left\" valign=\"top\" width=\"55%\"/>\n<thead>\n<tr class=\"First First Last Last\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"2\">Patient Information \n <br/> TAZAROTENE (taz-AR-oh-teen) \n <br/> Cream, 0.05% and 0.1%\n </th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First First Last Last\">\n<td align=\"left\" colspan=\"2\">This Patient Information has been approved by the U.S. Food and Drug Administration.                                       Revised: 12/2023                   </td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Important information</span>: Tazarotene cream is for use on skin only. Do not use tazarotene cream in your eyes, mouth, or vagina.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is the most important information I should know about tazarotene cream? \n <br/> Tazarotene cream may cause birth defects if used during pregnancy.\n </span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Females must not be pregnant when they start using tazarotene cream or become pregnant during treatment with tazarotene cream.</span>\n</li>\n<li>For females who are able to get pregnant:\n \n <ul class=\"Circle\">\n<li>Your doctor will order a pregnancy test for you within 2 weeks before you begin treatment with tazarotene cream to be sure that you are not pregnant. Your doctor will decide when to do the test.</li>\n<li>Begin treatment with tazarotene cream during a normal menstrual period.</li>\n<li>Use an effective form of birth control during treatment with tazarotene cream. Talk with your doctor about birth control options that may be used to prevent pregnancy during treatment with tazarotene cream.</li>\n<li>\n<span class=\"Bold\">Stop using tazarotene cream and tell your doctor right away if you become pregnant while using tazarotene cream.</span>\n</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is tazarotene cream?</span>\n<ul class=\"Disc\">\n<li>Tazarotene cream 0.05% and 0.1% is a prescription medicine used on the skin (topical) to treat people with plaque psoriasis.</li>\n<li>Tazarotene cream 0.1% is also used on the skin to treat people with acne vulgaris.</li>\n<li>It is not known if tazarotene cream is safe and effective for:\n \n <ul class=\"Circle\">\n<li>the treatment of plaque psoriasis in children under 18 years of age</li>\n<li>the treatment of acne vulgaris in children under 12 years of age</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Who should not use tazarotene cream? \n <br/> Do not use tazarotene cream if you:\n </span>\n<ul class=\"Disc\">\n<li>are pregnant or plan to become pregnant. See \"\n \n <span class=\"Bold\"><a href=\"#Important\">What is the most important information I should know about tazarotene cream?</a></span>\" at the beginning of this leaflet.\n \n </li>\n<li>are allergic to tazarotene or any of the ingredients in tazarotene cream. See the end of this leaflet for a complete list of ingredients in tazarotene cream.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What should I tell my doctor before using tazarotene cream? \n <br/> Before you use tazarotene cream, tell your doctor about all of your medical conditions, including if you:\n </span>\n<ul class=\"Disc\">\n<li>have eczema or any other skin problems</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if tazarotene cream passes into your breast milk. Talk to your doctor about using tazarotene cream while breastfeeding.</li>\n</ul>Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. \n <br/>\n<span class=\"Bold\">Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight</span>. \n <br/> Also, tell your doctor about any cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How should I use tazarotene cream?</span>\n<ul class=\"Disc\">\n<li>Use tazarotene cream exactly as your doctor tells you to use it.</li>\n<li>Apply tazarotene cream 1 time each day, in the evening.</li>\n<li>\n<span class=\"Bold\">Do not</span>get tazarotene cream in your eyes, on your eyelids, or in your mouth. If tazarotene cream gets in or near your eyes, rinse them well with water. Call your doctor or get medical help if you have eye irritation that does not go away.\n \n </li>\n<li>Wash your hands after applying tazarotene cream.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Follow these instructions for applying tazarotene cream:</span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">If you have psoriasis:</span>\n<ul class=\"Circle\">\n<li>If you shower or bathe before applying tazarotene cream, your skin should be dry before applying the cream.</li>\n<li>You may use a cream or lotion to soften or moisten your skin at least 1 hour before you apply tazarotene cream.</li>\n<li>Apply a thin layer of tazarotene cream to cover only the psoriasis lesions.</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">If you have acne:</span>\n<ul class=\"Circle\">\n<li>Gently wash and dry your face before applying tazarotene cream.</li>\n<li>Apply a thin layer of tazarotene cream to cover only the acne lesions.</li>\n</ul>\n</li>\n<li>If you swallow tazarotene cream, call your doctor or go to the nearest hospital emergency room right away.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What should I avoid while using tazarotene cream?</span>\n<ul class=\"Disc\">\n<li>Avoid sunlight, including sunlamps, during treatment with tazarotene cream. Tazarotene cream can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.</li>\n<li>Talk to your doctor if you get a sunburn during treatment with tazarotene cream. If you get a sunburn, do not use tazarotene cream until your sunburn is healed.</li>\n<li>Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry.</li>\n<li>Avoid using tazarotene cream on unaffected skin or skin with eczema because it may cause severe irritation.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the possible side effects of tazarotene cream? \n <br/> Tazarotene cream may cause serious side effects, including:\n </span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Skin irritation and allergic reactions (hypersensitivity).</span>Tazarotene cream may cause increased skin irritation and hives. Tell your doctor if you develop hives, or itching, burning, redness, or peeling of your skin during treatment with tazarotene cream. If you develop hives or skin irritation, your doctor may tell you to stop using tazarotene cream until your skin heals, tell you to use tazarotene cream less often, or change your tazarotene cream dose. Also, wind or cold weather may be more irritating to your skin while you are using tazarotene cream.\n \n </li>\n<li>\n<span class=\"Bold\">Sensitivity to sunlight and risk of sunburn.</span>See \"\n \n <span class=\"Bold\"><a href=\"#Avoid\">What should I avoid while using tazarotene cream?</a></span>\"\n \n </li>\n</ul>\n<span class=\"Bold\">The most common side effects of tazarotene cream in people with psoriasis include</span>itching, redness and burning. \n <br/>\n<span class=\"Bold\">The most common side effects of tazarotene cream in people with acne include</span>peeling, dry skin, redness and burning. These are not all the possible side effects of tazarotene cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How should I store tazarotene cream?</span>\n<ul class=\"Disc\">\n<li>Store tazarotene cream at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>Keep tazarotene cream and all medicines out of the reach of children.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of tazarotene cream.</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tazarotene cream for a condition for which it was not prescribed. Do not give tazarotene cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about tazarotene cream that is written for health professionals.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in tazarotene cream? \n <br/> Active ingredient:\n </span>tazarotene \n <br/>\n<span class=\"Bold\">Inactive ingredients:</span> benzyl alcohol 1%, carbomer copolymer type A, carbomer homopolymer type B, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium hydroxide, sodium thiosulfate, and sorbitan monooleate\n \n </td>\n</tr>\n<tr class=\"Botrule Last Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Distributed by:</span>\n<br/> Cosette Pharmaceuticals, Inc.             8-TAZCPLNC1 \n <br/> South Plainfield, NJ 07080                   VC7727\n \n </td>\n</tr>\n</tbody>\n</table></div>" }

NDC 0713-0670-31

{ "type": "p", "children": [], "text": "\nNDC 0713-0670-31\n" }

Tazarotene Cream 0.1%

{ "type": "p", "children": [], "text": "\nTazarotene Cream 0.1%\n" }

30 g

{ "type": "p", "children": [], "text": "\n30 g\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

For Topical Use only - Not for Oral, Ophthalmic or Intravaginal Use.

{ "type": "p", "children": [], "text": "\nFor Topical Use only - Not for Oral, Ophthalmic or Intravaginal Use.\n" }

Cosette Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "\nCosette Pharmaceuticals, Inc.\n" }

NDC 0713-0670-60

{ "type": "p", "children": [], "text": "\nNDC 0713-0670-60\n" }

Tazarotene Cream 0.1%

{ "type": "p", "children": [], "text": "\nTazarotene Cream 0.1%\n" }

60 g

{ "type": "p", "children": [], "text": "\n60 g\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

For Topical Use only - Not for Oral, Ophthalmic or Intravaginal Use.

{ "type": "p", "children": [], "text": "\nFor Topical Use only - Not for Oral, Ophthalmic or Intravaginal Use.\n" }

Cosette Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "\nCosette Pharmaceuticals, Inc.\n" }

NDC 0713-0765-31

{ "type": "p", "children": [], "text": "\nNDC 0713-0765-31\n" }

Tazarotene Cream 0.05%

{ "type": "p", "children": [], "text": "\nTazarotene Cream 0.05%\n" }

30 g

{ "type": "p", "children": [], "text": "\n30 g\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

For Topical Use only. Not for Ophthalmic Use.

{ "type": "p", "children": [], "text": "\nFor Topical Use only. Not for Ophthalmic Use.\n" }

Cosette Pharmaceuticals, Inc. NDC 0713-0765-60

{ "type": "p", "children": [], "text": "\nCosette Pharmaceuticals, Inc.\n\n\n\n\nNDC 0713-0765-60\n" }

Tazarotene Cream 0.05%

{ "type": "p", "children": [], "text": "\nTazarotene Cream 0.05%\n" }

60 g

{ "type": "p", "children": [], "text": "\n60 g\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

For Topical Use only. Not for Ophthalmic Use.

{ "type": "p", "children": [], "text": "\nFor Topical Use only. Not for Ophthalmic Use.\n" }

Cosette Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "\nCosette Pharmaceuticals, Inc. \n \n\n\n" }

Tazarotene gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.

Tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.

The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

It is recommended that treatment starts with tazarotene gel, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm2) of tazarotene gel once per day, in the evening, to cover only the psoriatic lesions on no more than 20% of body surface area. If a bath or shower is taken prior to application, the skin should be dry before applying the gel. If emollients are used, they should be applied at least an hour before application of tazarotene gel. Because unaffected skin may be more susceptible to irritation, application of tazarotene to these areas should be carefully avoided. Tazarotene gel was investigated for up to 12 months during clinical trials for psoriasis.

Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm2) of tazarotene gel 0.1% once per day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. Tazarotene gel was investigated for up to 12 weeks during clinical trials for acne. Use effective sunscreens and wear protective clothing while using tazarotene gel [see Warnings and Precautions (5.3)].

Gel, 0.05% and 0.1%, in 30 g and 100 g tubes. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a translucent, aqueous gel.

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Tazarotene gel is contraindicated in:

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{ "type": "ul", "children": [ "Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].", "Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions (5.2)]." ], "text": "" }

Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, tazarotene gel may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis.

Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals.

Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance and causes fetal malformations in animals, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology (12.3)].

There were thirteen reported pregnancies in subjects who participated in the clinical trials for topical tazarotene. Nine of the subjects had been treated with topical tazarotene, and the other four had been treated with vehicle. One of the subjects who was treated with tazarotene cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical tazarotene during the clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown.

Females of Child-bearing Potential Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene gel is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered.

A negative result for pregnancy test should be obtained within 2 weeks prior to tazarotene gel therapy. Tazarotene gel therapy should begin during a normal menstrual period [see Use in Specific Populations (8.1)].

Application of tazarotene gel may cause excessive irritation in the skin of certain sensitive individuals. Local reactions (including blistering and skin desquamation, pruritus, burning, erythema) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene.

If these adverse reactions occur, consider discontinuing the medication or reducing the dosing frequency, as appropriate, until the integrity of the skin is restored. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate treatment.

Concomitant topical medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before treatment with tazarotene gel is initiated.

Tazarotene gel, should not be used on eczematous skin, as it may cause severe irritation.

Weather extremes, such as wind or cold, may be more irritating to patients using tazarotene gel.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during the use of tazarotene gel. Patients must be warned to use sunscreens and protective clothing when using tazarotene gel. Patients with sunburn should be advised not to use tazarotene gel until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using tazarotene gel.

Tazarotene gel should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Psoriasis A total of 439 subjects 14 to 87 years of age were treated with tazarotene gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported with tazarotene gel, 0.05% and 0.1% occurring in 10 to 30% of subjects, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Reactions occurring in 1 to 10% of subjects included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in "psoriasis worsening" and "sun-induced erythema" were noted in some subjects over the 4th to 12th months of treatment as compared to the first three months of a 1 year study. In general, the incidence of adverse events with tazarotene gel 0.05% was 2 to 5% lower than that seen with tazarotene gel 0.1%.

Acne A total of 596 subjects 12 to 44 years of age were treated with tazarotene gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported during clinical trials with tazarotene gel, 0.1% in the treatment of acne occurring in 10 to 30% of subjects, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Reactions occurring in 1 to 10% of subjects included irritation, skin pain, fissuring, localized edema and skin discoloration.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during postapproval use of tazarotene.

Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.

No formal drug-drug interaction studies were conducted with tazarotene gel.

{ "type": "p", "children": [], "text": "No formal drug-drug interaction studies were conducted with tazarotene gel." }

In a trial of 27 healthy female subjects between the ages of 20-55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD Cmax and AUC0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng·hr/mL, respectively) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

{ "type": "p", "children": [], "text": "In a trial of 27 healthy female subjects between the ages of 20-55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD Cmax and AUC0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng·hr/mL, respectively) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle." }

The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

{ "type": "p", "children": [], "text": "The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated." }

Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazarotene gel may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from tazarotene gel during pregnancy; therefore, tazarotene gel should be discontinued as soon as pregnancy is recognized [see Contraindications (4), Warnings and Precautions (5.1), Clinical Pharmacology (12.3)]. Limited case reports of pregnancy in females enrolled in clinical trials for tazarotene gel have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown.

In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 0.5 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene gel, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification. In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1%, there were single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.

In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 0.5 and 13 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays. In pregnant rats, tazarotene dosed orally prior to mating through early gestation resulted in decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations at doses approximately 2 times higher than the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1% [see Data].

The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data In rats, a tazarotene gel, 0.05% formulation dosed topically during gestation days 6 through 17 at 0.25 mg/kg/day, which represented 0.5 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1% (i.e., 2 mg/cm2 over a 20% body surface area), resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel, which represented 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1%, during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.

When tazarotene was given orally to animals, developmental delays were seen in rats, and malformations and post-implantation loss were observed in rats and rabbits at doses producing 0.5 and 13 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1%.

In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, which represented 2 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1%, classic developmental effects of retinoids were observed including decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights. A low incidence of retinoid-related malformations was observed at that dose.

In a pre- and postnatal development toxicity study, topical administration of tazarotene gel (0.125 mg/kg/day) to pregnant female rats from gestation day 16 through lactation day 20 reduced pup survival, but did not affect the reproductive capacity of the offspring. Based on data from another study, the maximum systemic exposure in the rat would be 0.3 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1%.

Risk Summary There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of 14C-tazarotene gel to the skin of lactating rats, radioactivity was detected in rat milk. The lack of clinical data during lactation precludes a clear determination of the risk of tazarotene gel to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tazarotene gel and any potential adverse effects on the breastfed child from tazarotene gel or from the underlying maternal condition.

Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating tazarotene gel therapy which should begin during a menstrual period.

Contraception Females Based on animal studies, tazarotene gel may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with tazarotene gel.

The safety and efficacy of tazarotene gel have not been established in pediatric patients with psoriasis or acne under the age of 12 years.

Of the total number of subjects in clinical trials of tazarotene gel for plaque psoriasis, 163 were over the age of 65. Subjects over 65 years of age experienced more adverse events and lower treatment success rates after 12 weeks of use of tazarotene gel compared with those 65 years of age and younger. Currently there is no other clinical experience on the differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Tazarotene gel for the treatment of acne has not been clinically evaluated in persons over the age of 65.

Excessive topical use of tazarotene gel, 0.05% and 0.1% may lead to marked redness,  peeling, or discomfort [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Excessive topical use of tazarotene gel, 0.05% and 0.1% may lead to marked redness,  peeling, or discomfort [see Warnings and Precautions (5.2)]." }

Tazarotene gel, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

{ "type": "p", "children": [], "text": "Tazarotene gel, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary." }

Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel.

{ "type": "p", "children": [], "text": "Tazarotene gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel." }

Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below:

{ "type": "p", "children": [], "text": "Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below:" }

Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.

{ "type": "p", "children": [], "text": "Tazarotene gel, 0.05% and 0.1% contains the following inactive ingredients: benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine." }

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of plaque psoriasis and facial acne vulgaris is unknown.

The pharmacodynamics of tazarotene gel in the treatment of plaque psoriasis and facial acne vulgaris are unknown.

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly bound to plasma proteins (greater than 99%).

Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways. The half-life of tazarotenic acid was approximately 18 hours, following topical application of tazarotene to normal, acne or psoriatic skin.

The human in vivo studies described below were conducted with tazarotene gel applied topically at approximately 2 mg/cm2 and left on the skin for 10 to 12 hours. Both the peak plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) refer to the active metabolite only.

Two single, topical dose studies were conducted using 14C-tazarotene gel. Systemic absorption, as determined from radioactivity in the excreta, was less than 1% of the applied dose (without occlusion) in six subjects with psoriasis and approximately 5% of the applied dose (under occlusion) in six healthy subjects. One non-radiolabeled single-dose study comparing the 0.05% gel to the 0.1% gel in healthy subjects indicated that the Cmax and AUC were 40% higher for the 0.1% gel.

After 7 days of topical dosing with measured doses of tazarotene 0.1% gel on 20% of the total body surface without occlusion in 24 healthy subjects, the Cmax for tazarotenic acid was 0.72 ± 0.58 ng/mL (mean ± SD) occurring 9 hours after the last dose, and the AUC0-24hr for tazarotenic acid was 10.1 ± 7.2 ng·hr/mL. Systemic absorption was 0.91 ± 0.67% of the applied dose.

In a 14-day study in five subjects with psoriasis, measured doses of tazarotene 0.1% gel were applied daily by nursing staff to involved skin without occlusion (8 to 18% of total body surface area; mean ± SD: 13 ± 5%). The Cmax for tazarotenic acid was 12.0 ± 7.6 ng/mL occurring 6 hours after the final dose, and the AUC0-24hr for tazarotenic acid was 105 ± 55 ng·hr/mL. Systemic absorption was 14.8 ± 7.6% of the applied dose. Extrapolation of these results to represent dosing on 20% of total body surface yielded estimates for tazarotenic acid with Cmax of 18.9 ± 10.6 ng/mL and AUC0-24hr of 172 ± 88 ng·hr/mL.

An in vitro percutaneous absorption study, using radiolabeled drug and freshly excised human skin or human cadaver skin, indicated that approximately 4 to 5% of the applied dose was in the stratum corneum (tazarotene: tazarotenic acid = 5:1) and 2 to 4% was in the viable epidermis-dermis layer (tazarotene: tazarotenic acid = 2:1) 24 hours after topical application of the gel.

A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in the rat 0.3 times that seen in subjects treated with the MRHD of tazarotene gel, 0.1%.

A long-term study with topical administration of up to 0.1% tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals. Systemic exposure at the highest dose was 2 times that seen in subjects treated with the MRHD of tazarotene gel, 0.1%.

Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.

No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure in the rat at the highest dose was 0.3 times that observed in subjects treated with the MRHD of tazarotene gel, 0.1%.

No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene, which produced systemic exposure that was approximately equivalent to that observed in subjects treated with the MRHD of tazarotene gel, 0.1%.

No impairment of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral doses of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose, which produced systemic exposure 2 times that observed in subjects treated with the MRHD of tazarotene gel, 0.1% [see Use in Specific Populations (8.1)].

Psoriasis: In two large vehicle-controlled clinical trials, tazarotene gel, 0.05% and 0.1% applied once daily for 12 weeks was significantly more effective than vehicle in reducing the severity of the clinical signs of plaque psoriasis covering up to 20% of body surface area. In one of the studies, subjects were followed up for an additional 12 weeks following cessation of therapy with tazarotene gel. Mean baseline scores and changes from baseline (reductions) after treatment in these two trials are shown in Table 1.

{ "type": "p", "children": [], "text": "\nPsoriasis: In two large vehicle-controlled clinical trials, tazarotene gel, 0.05% and 0.1% applied once daily for 12 weeks was significantly more effective than vehicle in reducing the severity of the clinical signs of plaque psoriasis covering up to 20% of body surface area. In one of the studies, subjects were followed up for an additional 12 weeks following cessation of therapy with tazarotene gel. Mean baseline scores and changes from baseline (reductions) after treatment in these two trials are shown in Table 1." }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="0"> <caption> <span>Table 1. Plaque Elevation, Scaling, and Erythema in Two Controlled Clinical Trials for Psoriasis </span> </caption> <colgroup> <col width="8.39166736948638%"/> <col width="6.15670068314076%"/> <col width="9.08324196677069%"/> <col width="6.88201062663406%"/> <col width="6.87357679008181%"/> <col width="6.52778949143966%"/> <col width="7.37960698321667%"/> <col width="6.88201062663406%"/> <col width="6.87357679008181%"/> <col width="6.9241798093953%"/> <col width="6.89887829973855%"/> <col width="6.91574597284305%"/> <col width="6.87357679008181%"/> <col width="7.33743780045543%"/> </colgroup> <tfoot> <tr class="First Last"> <td colspan="14">Plaque elevation, scaling, and erythema scored on a 0-4 scale with 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.<br/> B*=Mean Baseline Severity: C-12*=Mean Change from Baseline at end of 12 weeks of therapy:<br/> C-24*=Mean Change from Baseline at week 24 (12 weeks after the end of therapy).<br/> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td align="justify" class="Lrule Rrule" colspan="2" rowspan="3" valign="top">  <br/> </td><td align="center" class="Rrule" colspan="4" valign="top"> <span class="Bold">Tazarotene Gel</span>,<span class="Bold"> 0.05%</span> <br/> </td><td align="center" class="Rrule" colspan="4" valign="top"> <span class="Bold">Tazarotene Gel</span>,<span class="Bold"> 0.1%</span> <br/> </td><td align="center" class="Rrule" colspan="4" valign="top"> <span class="Bold">Vehicle Gel</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="top"> Trunk/Arm/Leg<br/> Lesions<br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> Knee/Elbow<br/> Lesions<br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> Trunk/Arm/Leg<br/> Lesions<br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> Knee/Elbow<br/> Lesions<br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> Trunk/Arm/Leg<br/> Lesions<br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> Knee/Elbow<br/> Lesions<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> N=108<br/> </td><td align="center" class="Rrule" valign="top"> N=111<br/> </td><td align="center" class="Rrule" valign="top"> N=108<br/> </td><td align="center" class="Rrule" valign="top"> N=111<br/> </td><td align="center" class="Rrule" valign="top"> N=108<br/> </td><td align="center" class="Rrule" valign="top"> N=112<br/> </td><td align="center" class="Rrule" valign="top"> N=108<br/> </td><td align="center" class="Rrule" valign="top"> N=112<br/> </td><td align="center" class="Rrule" valign="top"> N=108<br/> </td><td align="center" class="Rrule" valign="top"> N=113<br/> </td><td align="center" class="Rrule" valign="top"> N=108<br/> </td><td align="center" class="Rrule" valign="top"> N=113<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> Plaque<br/> Elevation<br/> </td><td align="justify" class="Rrule" valign="top"> B*<br/> C-12*<br/> C-24*<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -1.4<br/> -1.2<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.3<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.3<br/> -1.1<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.1<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -1.4<br/> -1.1<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.4<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.5<br/> -1.0<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.3<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.4</span> <br/> -0.8<br/> -0.9<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -0.7<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -0.7<br/> -0.7<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -0.6<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> Scaling<br/> </td><td align="justify" class="Rrule" valign="top"> B*<br/> C-12*<br/> C-24*<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.4</span> <br/> -1.1<br/> -0.9<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -1.1<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -1.1<br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -0.9<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.4</span> <br/> -1.3<br/> -1.0<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -1.3<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -1.2<br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.7</span> <br/> -1.2<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.4</span> <br/> -0.7<br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.6</span> <br/> -0.7<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -0.6<br/> -0.7<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.7</span> <br/> -0.6<br/> </td> </tr> <tr class="Last"> <td align="justify" class="Lrule Rrule" valign="top"> Erythema<br/> </td><td align="justify" class="Rrule" valign="top"> B*<br/> C-12*<br/> C-24*<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.4</span> <br/> -1.0<br/> -1.1<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.7</span> <br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.2</span> <br/> -0.9<br/> -0.7<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.4</span> <br/> -1.0<br/> -0.9<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.8</span> <br/> -1.1<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.3</span> <br/> -1.0<br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -0.8<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.3</span> <br/> -0.6<br/> -0.7<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.7</span> <br/> -0.5<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.2</span> <br/> -0.5<br/> -0.6<br/> </td><td align="center" class="Rrule" valign="top"> <span class="Underline">2.5</span> <br/> -0.5<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"0\">\n<caption>\n<span>Table 1. Plaque Elevation, Scaling, and Erythema in Two Controlled Clinical Trials for Psoriasis \n\t\t\t</span>\n</caption>\n<colgroup>\n<col width=\"8.39166736948638%\"/>\n<col width=\"6.15670068314076%\"/>\n<col width=\"9.08324196677069%\"/>\n<col width=\"6.88201062663406%\"/>\n<col width=\"6.87357679008181%\"/>\n<col width=\"6.52778949143966%\"/>\n<col width=\"7.37960698321667%\"/>\n<col width=\"6.88201062663406%\"/>\n<col width=\"6.87357679008181%\"/>\n<col width=\"6.9241798093953%\"/>\n<col width=\"6.89887829973855%\"/>\n<col width=\"6.91574597284305%\"/>\n<col width=\"6.87357679008181%\"/>\n<col width=\"7.33743780045543%\"/>\n</colgroup>\n<tfoot>\n<tr class=\"First Last\">\n<td colspan=\"14\">Plaque elevation, scaling, and erythema scored on a 0-4 scale with 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.<br/> B*=Mean Baseline Severity: C-12*=Mean Change from Baseline at end of 12 weeks of therapy:<br/> C-24*=Mean Change from Baseline at week 24 (12 weeks after the end of therapy).<br/>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"justify\" class=\"Lrule Rrule\" colspan=\"2\" rowspan=\"3\" valign=\"top\">  <br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"4\" valign=\"top\"> <span class=\"Bold\">Tazarotene Gel</span>,<span class=\"Bold\"> 0.05%</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"4\" valign=\"top\"> <span class=\"Bold\">Tazarotene Gel</span>,<span class=\"Bold\"> 0.1%</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"4\" valign=\"top\"> <span class=\"Bold\">Vehicle Gel</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"> Trunk/Arm/Leg<br/> Lesions<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> Knee/Elbow<br/> Lesions<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> Trunk/Arm/Leg<br/> Lesions<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> Knee/Elbow<br/> Lesions<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> Trunk/Arm/Leg<br/> Lesions<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> Knee/Elbow<br/> Lesions<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> N=108<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=111<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=108<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=111<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=108<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=112<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=108<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=112<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=108<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=113<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=108<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=113<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> Plaque<br/> Elevation<br/> </td><td align=\"justify\" class=\"Rrule\" valign=\"top\"> B*<br/> C-12*<br/> C-24*<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -1.4<br/> -1.2<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.3<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.3<br/> -1.1<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.1<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -1.4<br/> -1.1<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.4<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.5<br/> -1.0<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.3<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.4</span>\n<br/> -0.8<br/> -0.9<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -0.7<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -0.7<br/> -0.7<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -0.6<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> Scaling<br/> </td><td align=\"justify\" class=\"Rrule\" valign=\"top\"> B*<br/> C-12*<br/> C-24*<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.4</span>\n<br/> -1.1<br/> -0.9<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -1.1<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -1.1<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -0.9<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.4</span>\n<br/> -1.3<br/> -1.0<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -1.3<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -1.2<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.7</span>\n<br/> -1.2<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.4</span>\n<br/> -0.7<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.6</span>\n<br/> -0.7<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -0.6<br/> -0.7<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.7</span>\n<br/> -0.6<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> Erythema<br/> </td><td align=\"justify\" class=\"Rrule\" valign=\"top\"> B*<br/> C-12*<br/> C-24*<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.4</span>\n<br/> -1.0<br/> -1.1<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.7</span>\n<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.2</span>\n<br/> -0.9<br/> -0.7<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.4</span>\n<br/> -1.0<br/> -0.9<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.8</span>\n<br/> -1.1<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.3</span>\n<br/> -1.0<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -0.8<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.3</span>\n<br/> -0.6<br/> -0.7<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.7</span>\n<br/> -0.5<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.2</span>\n<br/> -0.5<br/> -0.6<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Underline\">2.5</span>\n<br/> -0.5<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

Global improvement over baseline at the end of 12 weeks of treatment in these two trials is shown in Table 2.

{ "type": "p", "children": [], "text": "Global improvement over baseline at the end of 12 weeks of treatment in these two trials is shown in Table 2." }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="671.517"> <caption> <span>Table 2. Global Improvement over Baseline after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Psoriasis</span> </caption> <colgroup> <col width="19.9841552782729%"/> <col width="13.3293721529016%"/> <col width="13.3293721529016%"/> <col width="13.339275103981%"/> <col width="13.339275103981%"/> <col width="13.339275103981%"/> <col width="13.339275103981%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="justify" class="Lrule Rrule" rowspan="2" valign="top">  <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Tazarotene Gel,</span><span class="Bold"> 0.05%</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Tazarotene Gel</span><span class="Bold">, 0.1%</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Vehicle Gel</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> N=81<br/> </td><td align="center" class="Rrule" valign="top"> N=93<br/> </td><td align="center" class="Rrule" valign="top"> N=79<br/> </td><td align="center" class="Rrule" valign="top"> N=69<br/> </td><td align="center" class="Rrule" valign="top"> N=84<br/> </td><td align="center" class="Rrule" valign="top"> N=91<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> 100% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 2 (2%)<br/> </td><td align="center" class="Rrule" valign="top"> 1 (1%)<br/> </td><td align="center" class="Rrule" valign="top"> 0<br/> </td><td align="center" class="Rrule" valign="top"> 0<br/> </td><td align="center" class="Rrule" valign="top"> 1 (1%)<br/> </td><td align="center" class="Rrule" valign="top"> 0<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> ≥75% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 23 (28%)<br/> </td><td align="center" class="Rrule" valign="top"> 17 (18%)<br/> </td><td align="center" class="Rrule" valign="top"> 30 (38%)<br/> </td><td align="center" class="Rrule" valign="top"> 17 (25%)<br/> </td><td align="center" class="Rrule" valign="top"> 10 (12%)<br/> </td><td align="center" class="Rrule" valign="top"> 9 (10%)<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> ≥50% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 42 (52%)<br/> </td><td align="center" class="Rrule" valign="top"> 39 (42%)<br/> </td><td align="center" class="Rrule" valign="top"> 51 (65%)<br/> </td><td align="center" class="Rrule" valign="top"> 36 (52%)<br/> </td><td align="center" class="Rrule" valign="top"> 28 (33%)<br/> </td><td align="center" class="Rrule" valign="top"> 21 (23%)<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> 1-49% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 21 (26%)<br/> </td><td align="center" class="Rrule" valign="top"> 32 (34%)<br/> </td><td align="center" class="Rrule" valign="top"> 18 (23%)<br/> </td><td align="center" class="Rrule" valign="top"> 23 (33%)<br/> </td><td align="center" class="Rrule" valign="top"> 27 (32%)<br/> </td><td align="center" class="Rrule" valign="top"> 32 (35%)<br/> </td> </tr> <tr class="Last"> <td align="justify" class="Lrule Rrule" valign="top"> No change or worse<br/> </td><td align="center" class="Rrule" valign="top"> 18 (22%)<br/> </td><td align="center" class="Rrule" valign="top"> 22 (24%)<br/> </td><td align="center" class="Rrule" valign="top"> 10 (13%)<br/> </td><td align="center" class="Rrule" valign="top"> 10 (14%)<br/> </td><td align="center" class="Rrule" valign="top"> 29 (35%)<br/> </td><td align="center" class="Rrule" valign="top"> 38 (42%)<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"671.517\">\n<caption>\n<span>Table 2. Global Improvement over Baseline after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Psoriasis</span>\n</caption>\n<colgroup>\n<col width=\"19.9841552782729%\"/>\n<col width=\"13.3293721529016%\"/>\n<col width=\"13.3293721529016%\"/>\n<col width=\"13.339275103981%\"/>\n<col width=\"13.339275103981%\"/>\n<col width=\"13.339275103981%\"/>\n<col width=\"13.339275103981%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"justify\" class=\"Lrule Rrule\" rowspan=\"2\" valign=\"top\">  <br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Tazarotene Gel,</span><span class=\"Bold\"> 0.05%</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Tazarotene Gel</span><span class=\"Bold\">, 0.1%</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Vehicle Gel</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> N=81<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=93<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=79<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=69<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=84<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=91<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> 100% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 2 (2%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 1 (1%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 0<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 0<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 1 (1%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 0<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> ≥75% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 23 (28%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 17 (18%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 30 (38%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 17 (25%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 10 (12%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 9 (10%)<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> ≥50% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 42 (52%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 39 (42%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 51 (65%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 36 (52%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 28 (33%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 21 (23%)<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> 1-49% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 21 (26%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 32 (34%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 18 (23%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 23 (33%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 27 (32%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 32 (35%)<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> No change or worse<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 18 (22%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 22 (24%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 10 (13%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 10 (14%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 29 (35%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 38 (42%)<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

The 0.1% gel was more effective than the 0.05% gel, but the 0.05% gel was associated with less local irritation than the 0.1% gel [see Adverse Reactions (6.1)].

{ "type": "p", "children": [], "text": "The 0.1% gel was more effective than the 0.05% gel, but the 0.05% gel was associated with less local irritation than the 0.1% gel [see Adverse Reactions (6.1)]." }

Acne: In two large vehicle-controlled trials, tazarotene gel, 0.1% applied once daily was significantly more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion counts after treatment for 12 weeks in these two trials are shown in Table 3.

{ "type": "p", "children": [], "text": "\nAcne: In two large vehicle-controlled trials, tazarotene gel, 0.1% applied once daily was significantly more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion counts after treatment for 12 weeks in these two trials are shown in Table 3." }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="641.592"> <caption> <span>Table 3. Reduction in Lesion Counts after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne </span> </caption> <colgroup> <col width="20.5949419568823%"/> <col width="19.8486733001658%"/> <col width="19.8486733001658%"/> <col width="19.8486733001658%"/> <col width="19.8590381426202%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="justify" class="Lrule Rrule" rowspan="2" valign="top">  <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Tazarotene Gel,</span><span class="Bold"> 0.1%</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Vehicle Gel</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> N=150<br/> </td><td align="center" class="Rrule" valign="top"> N=149<br/> </td><td align="center" class="Rrule" valign="top"> N=148<br/> </td><td align="center" class="Rrule" valign="top"> N=149<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> Noninflammatory<br/> lesions<br/> </td><td align="center" class="Rrule" valign="top"> 55%<br/> </td><td align="center" class="Rrule" valign="top"> 43%<br/> </td><td align="center" class="Rrule" valign="top"> 35%<br/> </td><td align="center" class="Rrule" valign="top"> 27%<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> Inflammatory lesions<br/> </td><td align="center" class="Rrule" valign="top"> 42%<br/> </td><td align="center" class="Rrule" valign="top"> 47%<br/> </td><td align="center" class="Rrule" valign="top"> 30%<br/> </td><td align="center" class="Rrule" valign="top"> 28%<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top"> Total lesions<br/> </td><td align="center" class="Rrule" valign="top"> 52%<br/> </td><td align="center" class="Rrule" valign="top"> 45%<br/> </td><td align="center" class="Rrule" valign="top"> 33%<br/> </td><td align="center" class="Rrule" valign="top"> 27%<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"641.592\">\n<caption>\n<span>Table 3. Reduction in Lesion Counts after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne \n\t\t\t</span>\n</caption>\n<colgroup>\n<col width=\"20.5949419568823%\"/>\n<col width=\"19.8486733001658%\"/>\n<col width=\"19.8486733001658%\"/>\n<col width=\"19.8486733001658%\"/>\n<col width=\"19.8590381426202%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"justify\" class=\"Lrule Rrule\" rowspan=\"2\" valign=\"top\">  <br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Tazarotene Gel,</span><span class=\"Bold\"> 0.1%</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Vehicle Gel</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> N=150<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=149<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=148<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=149<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> Noninflammatory<br/> lesions<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 55%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 43%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 35%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 27%<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> Inflammatory lesions<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 42%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 47%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 30%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 28%<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\" valign=\"top\"> Total lesions<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 52%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 45%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 33%<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 27%<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

Global improvement over baseline at the end of 12 weeks of treatment in these two trials is shown in Table 4.

{ "type": "p", "children": [], "text": "Global improvement over baseline at the end of 12 weeks of treatment in these two trials is shown in Table 4." }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="621.775"> <caption> <span>Table 4. Global Improvement over Baseline after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne </span> </caption> <colgroup> <col width="23.048128342246%"/> <col width="19.2513368983957%"/> <col width="17.7967914438503%"/> <col width="19.9465240641711%"/> <col width="19.9572192513369%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="justify" class="Lrule Rrule" rowspan="2" valign="top">  <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Tazarotene Gel</span><span class="Bold">, 0.1%</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top"> <span class="Bold">Vehicle Gel</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> N=105<br/> </td><td align="center" class="Rrule" valign="top"> N=117<br/> </td><td align="center" class="Rrule" valign="top"> N=117<br/> </td><td align="center" class="Rrule" valign="top"> N=110<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> 100% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 1 (1%)<br/> </td><td align="center" class="Rrule" valign="top"> 0<br/> </td><td align="center" class="Rrule" valign="top"> 0<br/> </td><td align="center" class="Rrule" valign="top"> 0<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> ≥75% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 40 (38%)<br/> </td><td align="center" class="Rrule" valign="top"> 21 (18%)<br/> </td><td align="center" class="Rrule" valign="top"> 23 (20%)<br/> </td><td align="center" class="Rrule" valign="top"> 11 (10%)<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> ≥50% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 71 (68%)<br/> </td><td align="center" class="Rrule" valign="top"> 56 (48%)<br/> </td><td align="center" class="Rrule" valign="top"> 47 (40%)<br/> </td><td align="center" class="Rrule" valign="top"> 32 (29%)<br/> </td> </tr> <tr class="Botrule"> <td align="justify" class="Lrule Rrule" valign="top"> 1-49% improvement<br/> </td><td align="center" class="Rrule" valign="top"> 23 (22%)<br/> </td><td align="center" class="Rrule" valign="top"> 49 (42%)<br/> </td><td align="center" class="Rrule" valign="top"> 48 (41%)<br/> </td><td align="center" class="Rrule" valign="top"> 46 (42%)<br/> </td> </tr> <tr class="Last"> <td align="justify" class="Lrule Rrule" valign="top"> No change or worse<br/> </td><td align="center" class="Rrule" valign="top"> 11 (10%)<br/> </td><td align="center" class="Rrule" valign="top"> 12 (10%)<br/> </td><td align="center" class="Rrule" valign="top"> 22 (19%)<br/> </td><td align="center" class="Rrule" valign="top"> 32 (29%)<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"621.775\">\n<caption>\n<span>Table 4. Global Improvement over Baseline after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne \n\t\t\t</span>\n</caption>\n<colgroup>\n<col width=\"23.048128342246%\"/>\n<col width=\"19.2513368983957%\"/>\n<col width=\"17.7967914438503%\"/>\n<col width=\"19.9465240641711%\"/>\n<col width=\"19.9572192513369%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"justify\" class=\"Lrule Rrule\" rowspan=\"2\" valign=\"top\">  <br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Tazarotene Gel</span><span class=\"Bold\">, 0.1%</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\"> <span class=\"Bold\">Vehicle Gel</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> N=105<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=117<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=117<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> N=110<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> 100% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 1 (1%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 0<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 0<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 0<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> ≥75% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 40 (38%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 21 (18%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 23 (20%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 11 (10%)<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> ≥50% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 71 (68%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 56 (48%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 47 (40%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 32 (29%)<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> 1-49% improvement<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 23 (22%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 49 (42%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 48 (41%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 46 (42%)<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td align=\"justify\" class=\"Lrule Rrule\" valign=\"top\"> No change or worse<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 11 (10%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 12 (10%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 22 (19%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 32 (29%)<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

Tazarotene gel is a translucent, aqueous gel, available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes.

{ "type": "p", "children": [], "text": "Tazarotene gel is a translucent, aqueous gel, available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes." }

Tazarotene gel, 0.05%    30 g    NDC 73473-309-30 Tazarotene gel, 0.05%    100 g  NDC 73473-309-10 Tazarotene gel, 0.1%      30 g    NDC 73473-310-30 Tazarotene gel, 0.1%      100 g  NDC 73473-310-10

{ "type": "p", "children": [], "text": "Tazarotene gel, 0.05%    30 g    NDC 73473-309-30 Tazarotene gel, 0.05%    100 g  NDC 73473-309-10 Tazarotene gel, 0.1%      30 g    NDC 73473-310-30 Tazarotene gel, 0.1%      100 g  NDC 73473-310-10" }

Storage: Store at 20℃ to 25℃ (68℉ to 77℉). Excursions permitted from 15℃ to 30℃ (59℉ to 86℉).

{ "type": "p", "children": [], "text": "Storage: Store at 20℃ to 25℃ (68℉ to 77℉). Excursions permitted from 15℃ to 30℃ (59℉ to 86℉)." }

100 g Tube Carton Label for Tazarotene Gel, 0.05%

{ "type": "p", "children": [], "text": "100 g Tube Carton Label for Tazarotene Gel, 0.05%" }

NDC 73473-309-10

{ "type": "p", "children": [], "text": "\nNDC 73473-309-10\n" }

Tazarotene Gel, 0.05% For Dermatologic Use Only Not for Ophthalmic Use Rx Only

{ "type": "p", "children": [], "text": "\nTazarotene Gel, 0.05%\n\nFor Dermatologic Use Only Not for Ophthalmic Use Rx Only\n" }

100 gram

{ "type": "p", "children": [], "text": "\n100 gram\n" }

100 g Tube Carton Label for Tazarotene Gel, 0.1%

{ "type": "p", "children": [], "text": "100 g Tube Carton Label for Tazarotene Gel, 0.1%" }

NDC 73473-310-10

{ "type": "p", "children": [], "text": "\nNDC 73473-310-10\n" }

Tazarotene Gel, 0.1% For Dermatologic Use Only Not for Ophthalmic Use Rx Only

{ "type": "p", "children": [], "text": "\nTazarotene Gel, 0.1%\n For Dermatologic Use Only Not for Ophthalmic Use Rx Only\n" }

100 gram

{ "type": "p", "children": [], "text": "\n100 gram\n" }

ARAZLO ®(tazarotene) lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

{ "type": "p", "children": [], "text": "ARAZLO\n \n ®(tazarotene) lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.\n\n " }

Apply a thin layer of ARAZLO to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes. If ARAZLO gets in or near eyes, rinse thoroughly with water.

{ "type": "p", "children": [], "text": "Apply a thin layer of ARAZLO to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes. If ARAZLO gets in or near eyes, rinse thoroughly with water." }

ARAZLO is for topical use only. Not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "ARAZLO is for topical use only. Not for oral, ophthalmic, or intravaginal use." }

Wash hands thoroughly after applying ARAZLO.

{ "type": "p", "children": [], "text": "Wash hands thoroughly after applying ARAZLO." }

Avoid concomitant use with oxidizing agents, such as benzoyl peroxide. If the concomitant use of ARAZLO with oxidizing agents is required, apply each at different times of the day (e.g. one in the morning and the other in the evening) [see Drug Interactions (7)] .

{ "type": "p", "children": [], "text": "Avoid concomitant use with oxidizing agents, such as benzoyl peroxide. If the concomitant use of ARAZLO with oxidizing agents is required, apply each at different times of the day (e.g. one in the morning and the other in the evening)\n \n [see\n \n Drug Interactions (7)]\n \n .\n\n " }

Use effective sunscreens and wear protective clothing while using ARAZLO [see Warnings and Precautions (5.3)] .

{ "type": "p", "children": [], "text": "Use effective sunscreens and wear protective clothing while using ARAZLO\n \n [see\n \n Warnings and Precautions (5.3)]\n \n .\n\n " }

Lotion, 0.045%

{ "type": "p", "children": [], "text": "Lotion, 0.045%" }

Each gram of ARAZLO contains 0.45 mg (0.045%) tazarotene in a white to off-white topical lotion.

{ "type": "p", "children": [], "text": "Each gram of ARAZLO contains 0.45 mg (0.045%) tazarotene in a white to off-white topical lotion." }

ARAZLO is contraindicated in pregnancy. ARAZLO may cause fetal harm when administered to a pregnant patient [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] .

{ "type": "p", "children": [], "text": "ARAZLO is contraindicated in pregnancy. ARAZLO may cause fetal harm when administered to a pregnant patient\n \n [see\n \n Warnings and Precautions (5.1),\n \n Use in Specific Populations (8.1, 8.3)]\n \n .\n\n " }

Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, ARAZLO may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy .Safety in pregnant patients has not been established. The potential risk to the fetus outweighs the potential benefit to the mother; therefore, discontinue ARAZLO as soon as pregnancy is recognized.

Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis. However, limited case reports of pregnancy in females enrolled in clinical trials for ARAZLO have not reported a clear association with tazarotene and major birth defects or miscarriage risk [see Contraindications (4), Use in Specific Populations (8.1)] .

Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Tazarotene is a teratogenic substance in animals, and it is not known what level of exposure is required for teratogenicity in humans.

Advise pregnant patients of the potential risk to a fetus. Obtain a pregnancy test within 2 weeks prior to ARAZLO therapy. Initiate ARAZLO therapy during a menstrual period. Advise patients of childbearing potential to use effective contraception during treatment with ARAZLO [see Dosage and Administration (2), Use in Specific Populations (8.3)] .

Patients using ARAZLO may experience application site pain, dryness, exfoliation, erythema, and pruritus. Depending upon severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of ARAZLO, or discontinue use. Therapy can be resumed, or the frequency of application can be increased, as the patient becomes able to tolerate treatment.

Avoid use of concomitant medications and cosmetics that have a strong drying effect. It is recommended to postpone treatment with ARAZLO until the drying effects of these products subside.

Avoid application of ARAZLO to eczematous or sunburned skin.

Because of heightened burning susceptibility, minimize unprotected exposure to ultraviolet light including sunlight and sunlamps during the use of ARAZLO. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use sunscreen products and protective clothing over treated areas when sun exposure cannot be avoided. Patients with sunburn should be advised not to use ARAZLO until fully recovered.

ARAZLO should be administered with caution if the patient is taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Weather extremes, such as wind or cold, may be more irritating to patients using ARAZLO.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In 2 multicenter, randomized, double-blind, vehicle-controlled clinical trials, subjects age 9 years and older applied ARAZLO or vehicle once daily for 12 weeks. The majority of subjects were White (74%) and female (66%). Approximately 22% were Hispanic/Latino and 42% were younger than 18 years of age, fourteen of 779 subjects (1.8%) treated with ARAZLO were between 9 years to less than 12 years of age. Adverse reactions reported by ≥1% of subjects treated with ARAZLO and more frequently than subjects treated with vehicle are summarized in Table 1. Most adverse reactions were mild to moderate in severity. Severe adverse reactions represented 1.3% of the subjects treated. Overall, 2.4% (19/779) of subjects discontinued ARAZLO because of local skin reactions.

Table 1:Adverse Reactions Reported by ≥1% of the ARAZLO Group and More Frequently than the Vehicle Group

<div class="scrollingtable"><table width="48%"> <col width="21%"/> <col width="18%"/> <col width="16%"/> <thead> <tr class="First"> <th align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="bottom"><span class="Bold">Adverse Reactions</span> <br/> <span class="Bold">N (%)</span></th> </tr> <tr class="Last"> <th align="left" class="Botrule Lrule Rrule" valign="bottom"></th><th align="center" class="Botrule Lrule Rrule" valign="bottom"><span class="Bold">ARAZLO</span> <br/> <span class="Bold">N=779</span></th><th align="center" class="Botrule Lrule Rrule" valign="bottom"><span class="Bold">Vehicle</span> <br/> <span class="Bold">N=791</span></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Application site pain defined as application site stinging, burning or pain</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="bottom"> <p class="First">Application site pain <a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="bottom"> <p class="First">41 (5)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="bottom"> <p class="First">2 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="bottom"> <p class="First">Application site dryness</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">30 (4)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="bottom"> <p class="First">Application site exfoliation</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">16 (2)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">0 (0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="bottom"> <p class="First">Application site erythema</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">15 (2)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">0 (0)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="bottom"> <p class="First">Application site pruritus</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">10 (1)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="bottom"> <p class="First">0 (0)</p> </td> </tr> </tbody> </table></div>

Skin irritation was evaluated by active assessment of erythema, scaling, itching, burning and stinging, with grades for none, mild, moderate, or severe. The maximum severity generally peaked at Week 2 of therapy and decreased thereafter. The percentage of subjects with these signs and symptoms at any post-baseline visit are summarized in Table 2.

Table 2: Incidence of Local Cutaneous Irritation at any Post-Baseline Visit

<div class="scrollingtable"><table cellpadding="0pt" width="48%"> <col width="11%"/> <col width="22%"/> <col width="22%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">ARAZLO Lotion</span> </p> <p> <span class="Bold">N=774</span> </p> <p>Mild/Moderate/Severe</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Vehicle Lotion</span> </p> <p> <span class="Bold">N=789</span> </p> <p>Mild/Moderate/Severe</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Erythema</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">49%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">38%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Scaling</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">51%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">23%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Itching</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">29%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">14%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Burning</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">30%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Stinging</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">22%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">5%</p> </td> </tr> </tbody> </table></div>

No formal drug-drug interaction studies were conducted with ARAZLO.

{ "type": "p", "children": [], "text": "No formal drug-drug interaction studies were conducted with ARAZLO." }

Concomitant use with oxidizing agents, as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene.

{ "type": "p", "children": [], "text": "Concomitant use with oxidizing agents, as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene." }

In a trial of 27 healthy female subjects, between the ages of 20–55 years, receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, the concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C maxand AUC 0-24of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng•hr/mL, respectively) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

{ "type": "p", "children": [], "text": "In a trial of 27 healthy female subjects, between the ages of 20–55 years, receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, the concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C\n \n maxand AUC\n \n 0-24of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng•hr/mL, respectively) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.\n\n " }

The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

{ "type": "p", "children": [], "text": "The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated." }

Risk Summary

ARAZLO is contraindicated in pregnancy.

There are no available data on ARAZLO use in pregnant patients to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, ARAZLO may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. The potential risk to the fetus outweighs the potential benefit to the mother; therefore, ARAZLO should be discontinued as soon as pregnancy is recognized.

In animal reproduction studies with pregnant rats, reduced fetal body weights and reduced skeletal ossification were observed after topical administration of a tazarotene gel formulation during the period of organogenesis at a dose equivalent to the maximum recommended human dose (MRHD) (based on AUC comparison). In animal reproduction studies with pregnant rabbits, single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies were observed after topical administration of a tazarotene gel formulation at 15 times the MRHD (based on AUC comparison) (see Data).

In animal reproduction studies with pregnant rats and rabbits, malformations, fetal toxicity, developmental delays, and/or behavioral delays were observed after oral administration of tazarotene during the period of organogenesis at doses 1 and 30 times, respectively, the MRHD (based on AUC comparison). In pregnant rats, decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations were observed after oral administration of tazarotene prior to mating through early gestation at doses 6 times the MRHD (based on AUC comparison) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In an embryofetal development study in rats, a tazarotene gel formulation, 0.5% (0.25 mg/kg/day tazarotene) was topically administered to pregnant rats during gestation days 6 through 17. Reduced fetal body weights and reduced skeletal ossification occurred at this dose (equivalent to the MRHD based on AUC comparison). In an embryofetal development study in rabbits, a tazarotene gel formulation, 0.5% (0.25 mg/kg/day tazarotene) was topically administered to pregnant rabbits during gestation days 6 through 18. Single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies were noted at this dose (15 times the MRHD based on AUC comparison).

When tazarotene was given orally to animals, developmental delays were seen in rats; malformations and post- implantation loss were observed in rats and rabbits at doses producing 1 and 30 times, respectively, the MRHD (based on AUC comparison).

In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, classic developmental effects of retinoids including decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights were observed at this dose (6 times the MRHD based on AUC comparison). A low incidence of retinoid-related malformations was observed at this dose.

In a pre- and postnatal development toxicity study, topical administration of a tazarotene gel formulation (0.125 mg/kg/day) to pregnant female rats from gestation day 16 through lactation day 20 reduced pup survival, but did not affect the reproductive capacity of the offspring. Based on data from another study, the systemic drug exposure in the rat at this dose would be equivalent to the MRHD (based on AUC comparison).

Risk Summary

There are no data on the presence of tazarotene or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of a 14C-tazarotene gel formulation to the skin of lactating rats, radioactivity was detected in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ARAZLO and any potential adverse effects on the breastfed child from ARAZLO.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use ARAZLO for the shortest duration possible while breastfeeding. Advise breastfeeding patients not to apply ARAZLO directly to the nipple and areola to prevent direct infant exposure.

Pregnancy Testing

Pregnancy testing is recommended for patients of childbearing potential within 2 weeks prior to initiating ARAZLO therapy which should begin during a menstrual period.

Contraception

Advise patients of childbearing potential to use effective contraception during treatment with ARAZLO.

Safety and effectiveness of ARAZLO for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years and older based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12-week clinical trials and an open-label pharmacokinetic study. A total of 300 pediatric subjects aged 9 to less than 17 years received ARAZLO in the clinical studies [see Clinical Pharmacology (12.3)and Clinical Studies (14)] .

The safety and effectiveness of ARAZLO in pediatric patients below the age of 9 years have not been established.

Clinical trials of ARAZLO did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.

Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, monitor the patient closely and administer appropriate supportive measures, as necessary.

{ "type": "p", "children": [], "text": "Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, monitor the patient closely and administer appropriate supportive measures, as necessary." }

ARAZLO (tazarotene) is a white to off-white lotion containing 0.045% tazarotene by weight for topical administration.

{ "type": "p", "children": [], "text": "ARAZLO (tazarotene) is a white to off-white lotion containing 0.045% tazarotene by weight for topical administration." }

Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below:

{ "type": "p", "children": [], "text": "Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below:" }

Tazarotene:

{ "type": "p", "children": [], "text": "Tazarotene:" }

Molecular Formula: C 21H 21NO 2S             Molecular Weight: 351.46

{ "type": "p", "children": [], "text": "Molecular Formula: C\n \n 21H\n \n 21NO\n \n 2S             Molecular Weight: 351.46\n\n " }

Each gram of ARAZLO contains 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.

{ "type": "p", "children": [], "text": "Each gram of ARAZLO contains 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%." }

Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of acne vulgaris is unknown.

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Tazarotenic acid is highly bound to plasma proteins (greater than 99%).

Systemic exposure following topical application of ARAZLO was evaluated in 28 subjects in an open-label, randomized, pharmacokinetic study. Subjects aged 9 years and older with moderate to severe acne applied approximately 4 grams of ARAZLO to the entire face (excluding eyes and lips), neck, upper chest, upper back and shoulders once daily for 14 Days.

The majority of collected samples had concentrations below the limit of quantification (LOQ) for tazarotene (0.005 ng/mL). The mean C maxand mean AUC (0-t)values for tazarotene from quantifiable samples were 0.007 ng/mL and 0.164 ng•hr/mL on Day 14 to 15, respectively. The mean C maxand AUC (0-t)of tazarotene in subjects aged 9 to less than 12 years was approximately 3.7 and 3.6 fold higher, respectively, compared to that observed in subjects 12 years and older.

Tazarotenic acid concentrations were measurable in the majority of samples following single and repeated topical administration of ARAZLO (LOQ = 0.005 ng/mL). The mean C maxand AUC (0-t)values for tazarotenic acid from quantifiable samples were 0.365 ng/mL and 5.72 ng•hr/mL on Days 14 to 15, respectively. The mean C maxand AUC (0-t)of tazarotenic acid in subjects aged 9 to less than 12 years was approximately 2.4 and 2.3 fold higher, respectively, compared to that observed in subjects 12 years and older.

A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in the rat equivalent to the MRHD (based on AUC comparison).

A long-term study with topical application of up to 0.1% of tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals. Tazarotenic acid systemic exposures at the highest dose was 7 times the MRHD (based on AUC comparison).

Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in human lymphocytes. Tazarotene was non-mutagenic in CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in an in vivo mouse micronucleus test.

No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of a tazarotene gel formulation up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure in the rat at the highest dose was equivalent to the MRHD (based on AUC comparison).

No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of tazarotene up to 1 mg/kg/day which produced a systemic exposure 4 times the MRHD (based on AUC comparison).

No impairment of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral doses of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose which produced a systemic exposure 6 times the MRHD (based on AUC comparison).

The safety and efficacy of once daily use of ARAZLO for the treatment of acne vulgaris were assessed in two multicenter, randomized, double-blind clinical trials in subjects 9 years and older with facial acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 non-inflammatory lesions (open and closed comedones) and two or fewer facial nodules. The majority of subjects were White (74%) and female (66%). Approximately 22% were Hispanic/Latino and 42% were younger than 18 years of age. The efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12. Success on the EGSS was defined as at least a 2-grade improvement from Baseline and an EGSS score of clear (0) or almost clear (1). Table 3 lists the efficacy results for trials 1 (NCT03168321) and 2 (NCT03168334).

{ "type": "p", "children": [], "text": "The safety and efficacy of once daily use of ARAZLO for the treatment of acne vulgaris were assessed in two multicenter, randomized, double-blind clinical trials in subjects 9 years and older with facial acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 non-inflammatory lesions (open and closed comedones) and two or fewer facial nodules. The majority of subjects were White (74%) and female (66%). Approximately 22% were Hispanic/Latino and 42% were younger than 18 years of age. The efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12. Success on the EGSS was defined as at least a 2-grade improvement from Baseline and an EGSS score of clear (0) or almost clear (1). Table 3 lists the efficacy results for trials 1 (NCT03168321) and 2 (NCT03168334)." }

<div class="scrollingtable"><table width="53%"> <caption> <span>Table 3: Efficacy Results at Week 12</span> </caption> <col width="20%"/> <col width="14%"/> <col width="11%"/> <col width="17%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Toprule" valign="top"> <p class="First"> <span class="Bold">Trial 1</span> </p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First"> <span class="Bold">ARAZLO Lotion</span> <br/> <span class="Bold">N=402</span> </p> </td><td align="center" class="Botrule Toprule" valign="top"> <p class="First"> <span class="Bold">Vehicle</span> <br/> <span class="Bold">N=411</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Treatment Difference</span> </p> <p> <span class="Bold">(95% Confidence Interval)</span> </p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">EGSS</span> </p> </td><td valign="top"></td><td valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Clear or Almost Clear and</p> </td><td align="center" valign="top"> <p class="First">25.5%</p> </td><td align="center" valign="top"> <p class="First">13%</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">12.5% (7.1%, 17.9%)</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">2-Grade Reduction from Baseline</p> </td><td class="Botrule" valign="top"></td><td class="Botrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">Non-Inflammatory Facial Lesions</span> </p> </td><td valign="top"></td><td valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Mean Absolute Reduction</p> </td><td align="center" valign="top"> <p class="First">21.0</p> </td><td align="center" valign="top"> <p class="First">16.4</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4.5 (2.6, 6.4)</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">    Mean Percent Reduction</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">51.4%</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">41.5%</p> </td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">Inflammatory Facial Lesions</span> </p> </td><td valign="top"></td><td valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Mean Absolute Reduction</p> </td><td align="center" valign="top"> <p class="First">15.6</p> </td><td align="center" valign="top"> <p class="First">12.4</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3.3 (1.9, 4.7)</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">    Mean Percent Reduction</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">55.5%</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">45.7%</p> </td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First"> <span class="Bold">Trial 2</span> </p> </td><td align="center" class="Botrule" valign="top"> <p class="First"> <span class="Bold">ARAZLO Lotion</span> <br/> <span class="Bold">N=397</span> </p> </td><td align="center" class="Botrule" valign="top"> <p class="First"> <span class="Bold">Vehicle</span> <br/> <span class="Bold">N=404</span> </p> </td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">EGSS</span> </p> </td><td valign="top"></td><td valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">Clear or Almost Clear and</p> <p>2-Grade Reduction from Baseline</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">29.6%</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">17.3%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12.3% (6.5%, 18.1%)</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">Non-Inflammatory Facial Lesions</span> </p> </td><td valign="top"></td><td valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Mean Absolute Reduction</p> </td><td align="center" valign="top"> <p class="First">24.6</p> </td><td align="center" valign="top"> <p class="First">16.6</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">8.1 (5.9, 10.2)</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">    Mean Percent Reduction</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">60%</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">41.6%</p> </td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">Inflammatory Facial Lesions</span> </p> </td><td valign="top"></td><td valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Mean Absolute Reduction</p> </td><td align="center" valign="top"> <p class="First">16.7</p> </td><td align="center" valign="top"> <p class="First">13.4</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3.2 (1.9, 4.5)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="top"> <p class="First">    Mean Percent Reduction</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">59.5%</p> </td><td align="center" class="Botrule" valign="top"> <p class="First">49%</p> </td><td class="Botrule Rrule" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"53%\">\n<caption>\n<span>Table 3: Efficacy Results at Week 12</span>\n</caption>\n<col width=\"20%\"/>\n<col width=\"14%\"/>\n<col width=\"11%\"/>\n<col width=\"17%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 1</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">ARAZLO Lotion</span>\n<br/>\n<span class=\"Bold\">N=402</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle</span>\n<br/>\n<span class=\"Bold\">N=411</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Treatment Difference</span>\n</p>\n<p>\n<span class=\"Bold\">(95% Confidence Interval)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">EGSS</span>\n</p>\n</td><td valign=\"top\"></td><td valign=\"top\"></td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Clear or Almost Clear and</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">25.5%</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">13%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">12.5% (7.1%, 17.9%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">2-Grade Reduction from Baseline</p>\n</td><td class=\"Botrule\" valign=\"top\"></td><td class=\"Botrule\" valign=\"top\"></td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Non-Inflammatory Facial Lesions</span>\n</p>\n</td><td valign=\"top\"></td><td valign=\"top\"></td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Absolute Reduction</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">21.0</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">16.4</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">4.5 (2.6, 6.4)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Percent Reduction</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">51.4%</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">41.5%</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Inflammatory Facial Lesions</span>\n</p>\n</td><td valign=\"top\"></td><td valign=\"top\"></td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Absolute Reduction</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">15.6</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">12.4</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">3.3 (1.9, 4.7)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Percent Reduction</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">55.5%</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">45.7%</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Trial 2</span>\n</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">ARAZLO Lotion</span>\n<br/>\n<span class=\"Bold\">N=397</span>\n</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle</span>\n<br/>\n<span class=\"Bold\">N=404</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">EGSS</span>\n</p>\n</td><td valign=\"top\"></td><td valign=\"top\"></td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">Clear or Almost Clear and</p>\n<p>2-Grade Reduction from Baseline</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">29.6%</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">17.3%</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">12.3% (6.5%, 18.1%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Non-Inflammatory Facial Lesions</span>\n</p>\n</td><td valign=\"top\"></td><td valign=\"top\"></td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Absolute Reduction</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">24.6</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">16.6</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">8.1 (5.9, 10.2)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Percent Reduction</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">60%</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">41.6%</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Inflammatory Facial Lesions</span>\n</p>\n</td><td valign=\"top\"></td><td valign=\"top\"></td><td class=\"Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Absolute Reduction</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">16.7</p>\n</td><td align=\"center\" valign=\"top\">\n<p class=\"First\">13.4</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"top\">\n<p class=\"First\">3.2 (1.9, 4.5)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Mean Percent Reduction</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">59.5%</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"top\">\n<p class=\"First\">49%</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

ARAZLO (tazarotene) Lotion, 0.045% is a white to off-white lotion supplied in a white aluminum tube as follows:

{ "type": "p", "children": [], "text": "ARAZLO (tazarotene) Lotion, 0.045% is a white to off-white lotion supplied in a white aluminum tube as follows:" }

{ "type": "ul", "children": [ "45 g (NDC 0187-2098-45)" ], "text": "" }

Storage and Handling Conditions

{ "type": "p", "children": [], "text": "\nStorage and Handling Conditions\n" }

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

{ "type": "p", "children": [], "text": "Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing." }

Advise the patient to read the FDA-approved patient labeling (Patient Information).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information)." }

Embryofetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryofetal Toxicity\n" }

Inform patients of childbearing potential of the potential risk to a fetus. To avoid pregnancy, advise these patients to use effective contraception during treatment with ARAZLO. Advise patients to discontinue the medication if pregnant and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1), (8.3)] .

{ "type": "p", "children": [], "text": "Inform patients of childbearing potential of the potential risk to a fetus. To avoid pregnancy, advise these patients to use effective contraception during treatment with ARAZLO. Advise patients to discontinue the medication if pregnant and to inform their healthcare provider of a known or suspected pregnancy\n \n [see\n \n Contraindications (4.1),\n \n Warnings and Precautions (5.1), and\n \n Use in Specific Populations (8.1), (8.3)]\n \n .\n\n " }

Lactation

{ "type": "p", "children": [], "text": "\nLactation\n" }

Advise patients to use ARAZLO for the shortest duration possible while breastfeeding. Advise breastfeeding patients not to apply ARAZLO directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)] .

{ "type": "p", "children": [], "text": "Advise patients to use ARAZLO for the shortest duration possible while breastfeeding. Advise breastfeeding patients not to apply ARAZLO directly to the nipple and areola to avoid direct infant exposure\n \n [see\n \n Use in Specific Populations (8.2)]\n \n .\n\n " }

Skin Irritation

{ "type": "p", "children": [], "text": "\nSkin Irritation\n" }

Advise patients to avoid applying ARAZLO to eczematous or sunburned skin. If undue irritation occurs, reduce frequency of application, temporarily interrupt treatment, or discontinue use. Treatment may be resumed once irritation subsides [see Warnings and Precautions (5.2)] .

{ "type": "p", "children": [], "text": "Advise patients to avoid applying ARAZLO to eczematous or sunburned skin. If undue irritation occurs, reduce frequency of application, temporarily interrupt treatment, or discontinue use. Treatment may be resumed once irritation subsides\n \n [see\n \n Warnings and Precautions (5.2)]\n \n .\n\n " }

Photosensitivity and Risk of Sunburn

{ "type": "p", "children": [], "text": "\nPhotosensitivity and Risk of Sunburn\n" }

Advise patients to minimize exposure to sunlight and sunlamps; recommend the use of sunscreen products and protective apparel (e.g., wide-brimmed hat) when sun exposure cannot be avoided. Advise patients to avoid using ARAZLO if also taking other medicines that may increase sensitivity to sunlight [see Warnings and Precautions (5.3)] .

{ "type": "p", "children": [], "text": "Advise patients to minimize exposure to sunlight and sunlamps; recommend the use of sunscreen products and protective apparel (e.g., wide-brimmed hat) when sun exposure cannot be avoided. Advise patients to avoid using ARAZLO if also taking other medicines that may increase sensitivity to sunlight\n \n [see\n \n Warnings and Precautions (5.3)]\n \n .\n\n " }

Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA

{ "type": "p", "children": [], "text": "\nDistributed by:\n Bausch Health US, LLC \n Bridgewater, NJ 08807 USA\n\n " }

Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada

{ "type": "p", "children": [], "text": "\nManufactured by:\n Bausch Health Companies Inc. \n Laval, Quebec H7L 4A8, Canada\n\n " }

Patented. See https://patents.ortho-dermatologics.com for US patent information. ARAZLO is a trademark of Bausch Health Companies Inc. or its affiliates. © 2023 Bausch Health Companies Inc. or its affiliates 9701202

{ "type": "p", "children": [], "text": "Patented. See https://patents.ortho-dermatologics.com for US patent information. \n ARAZLO is a trademark of Bausch Health Companies Inc. or its affiliates. \n © 2023 Bausch Health Companies Inc. or its affiliates \n 9701202\n " }

<div class="scrollingtable"><table width="100%"> <col width="100%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> <br/> <span class="Bold">ARAZLO <span class="Sup">®</span>(ah-RAZ-low) </span> <br/> <span class="Bold">(tazarotene)</span> <br/> <span class="Bold">lotion, for topical use</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Important information:</span>ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">What is the most important information I should know about ARAZLO?</span> </p> <p> <span class="Bold">ARAZLO may cause birth defects if used during pregnancy.</span> </p> <p> <span class="Bold">You must not be pregnant when you start using ARAZLO or become pregnant during treatment with ARAZLO.</span> </p> <ul> <li> <span class="Bold">For people who are able to get pregnant:</span> </li> <li>Your healthcare provider should order a pregnancy test for you within 2 weeks before you begin treatment with ARAZLO to be sure that you are not pregnant. Your healthcare provider will decide when to do the test.</li> <li>Begin treatment with ARAZLO during a normal menstrual period.</li> <li>Use an effective form of birth control (contraception) during treatment with ARAZLO. Talk with your healthcare provider about birth control options that may be used to prevent pregnancy during treatment with ARAZLO.</li> <li> <span class="Bold">Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment with ARAZLO.</span> </li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">What is ARAZLO?</span> </p> <p>ARAZLO is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne vulgaris.</p> <p>It is not known if ARAZLO is safe and effective in children under 9 years of age.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Do not use ARAZLO if you</span>are pregnant or plan to become pregnant. See, “What is the most important information I should know about ARAZLO?” at the beginning of this leaflet. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:</span> </p> <ul> <li>have eczema or any other skin problems</li> <li>are breastfeeding or plan to breastfeed. It is not known if ARAZLO passes into your breast milk. If you use ARAZLO while breastfeeding, use ARAZLO for the shortest time needed. Do not apply ARAZLO directly to the nipple and the areola to avoid your child being exposed to the medicine.</li> </ul> <p> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. </p> <p> <span class="Bold">Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight.</span>Ask your healthcare provider for a list of medicines if you are not sure. </p> <p> <span class="Bold">Especially tell your healthcare provider</span>about any medicines (such as benzoyl peroxide) used on your skin or cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin. </p> <p>Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">How should I use ARAZLO?</span> </p> <ul> <li>Use ARAZLO exactly as your healthcare provider tells you to use it.</li> <li>Apply a thin layer of ARAZLO to cover the affected areas 1 time each day.</li> <li>If you use other medicines on your skin such as benzoyl peroxide during treatment with ARAZLO, you should apply one in the morning and one in the evening to separate the application time.</li> <li>Do not get ARAZLO in your eyes, the corners of your nose, or in your mouth. If ARAZLO gets in your eyes, rinse them well with water. Call your healthcare provider or get medical help if you have eye irritation that does not go away.</li> <li>Wash your hands after applying ARAZLO.</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">What should I avoid during treatment with ARAZLO?</span> </p> <ul> <li>Avoid sunlight, including sunlamps during treatment with ARAZLO. ARAZLO can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen and wear a wide-brimmed hat and clothes that cover your skin if you have to be in sunlight.</li> <li>Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry.</li> <li>Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">What are the possible side effects of ARAZLO?</span> </p> <p> <span class="Bold">ARAZLO may cause serious side effects, including:</span> </p> <ul> <li>See, <span class="Bold">“What is the most important information I should know about ARAZLO?”</span> </li> <li> <span class="Bold">Skin irritation.</span>ARAZLO may cause application site skin pain, dryness, flaking or peeling, redness, and itching. Tell your healthcare provider if you develop any skin irritation during treatment with ARAZLO. If you develop any of these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you apply ARAZLO, or completely stop treatment with ARAZLO. Also, wind or cold weather may be more irritating to your skin during treatment with ARAZLO. </li> <li> <span class="Bold">Sensitivity to sunlight and risk of sunburn.</span>See, “What should I avoid during treatment with ARAZLO?” </li> <li> <span class="Bold">The most common side effects of ARAZLO include</span>skin pain, dryness, peeling, redness, and itching. </li> </ul> <p>These are not all the possible side effects of ARAZLO.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">How should I store ARAZLO?</span> </p> <ul> <li>Store ARAZLO at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>Do not freeze.</li> </ul> <p> <span class="Bold">Keep ARAZLO and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">General information about the safe and effective use of ARAZLO.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ARAZLO for a condition for which it was not prescribed. Do not give ARAZLO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ARAZLO that is written for health professionals.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">What are the ingredients in ARAZLO?</span> </p> <p> <span class="Bold">Active ingredient:</span>tazarotene </p> <p> <span class="Bold">Inactive ingredients:</span>carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70% </p> <p> <span class="Bold">Distributed by:</span>Bausch Health US, LLC, Bridgewater, NJ 08807 USA </p> <p> <span class="Bold">Manufactured by:</span>Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada <br/> Patented. See https://patents.ortho-dermatologics.com for US patent information. </p> <p>ARAZLO is a trademark of Bausch Health Companies Inc. or its affiliates.</p> <p>© 2023 Bausch Health Companies Inc. or its affiliates</p> <p>For more information, call 1-800-321-4576.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n<br/>\n<span class=\"Bold\">ARAZLO\n \n <span class=\"Sup\">®</span>(ah-RAZ-low)\n \n </span>\n<br/>\n<span class=\"Bold\">(tazarotene)</span>\n<br/>\n<span class=\"Bold\">lotion, for topical use</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Important information:</span>ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about ARAZLO?</span>\n</p>\n<p>\n<span class=\"Bold\">ARAZLO may cause birth defects if used during pregnancy.</span>\n</p>\n<p>\n<span class=\"Bold\">You must not be pregnant when you start using ARAZLO or become pregnant during treatment with ARAZLO.</span>\n</p>\n<ul>\n<li>\n<span class=\"Bold\">For people who are able to get pregnant:</span>\n</li>\n<li>Your healthcare provider should order a pregnancy test for you within 2 weeks before you begin treatment with ARAZLO to be sure that you are not pregnant. Your healthcare provider will decide when to do the test.</li>\n<li>Begin treatment with ARAZLO during a normal menstrual period.</li>\n<li>Use an effective form of birth control (contraception) during treatment with ARAZLO. Talk with your healthcare provider about birth control options that may be used to prevent pregnancy during treatment with ARAZLO.</li>\n<li>\n<span class=\"Bold\">Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment with ARAZLO.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">What is ARAZLO?</span>\n</p>\n<p>ARAZLO is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne vulgaris.</p>\n<p>It is not known if ARAZLO is safe and effective in children under 9 years of age.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use ARAZLO if you</span>are pregnant or plan to become pregnant. See, “What is the most important information I should know about ARAZLO?” at the beginning of this leaflet.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:</span>\n</p>\n<ul>\n<li>have eczema or any other skin problems</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if ARAZLO passes into your breast milk. If you use ARAZLO while breastfeeding, use ARAZLO for the shortest time needed. Do not apply ARAZLO directly to the nipple and the areola to avoid your child being exposed to the medicine.</li>\n</ul>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements.\n \n </p>\n<p>\n<span class=\"Bold\">Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight.</span>Ask your healthcare provider for a list of medicines if you are not sure.\n \n </p>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider</span>about any medicines (such as benzoyl peroxide) used on your skin or cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin.\n \n </p>\n<p>Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use ARAZLO?</span>\n</p>\n<ul>\n<li>Use ARAZLO exactly as your healthcare provider tells you to use it.</li>\n<li>Apply a thin layer of ARAZLO to cover the affected areas 1 time each day.</li>\n<li>If you use other medicines on your skin such as benzoyl peroxide during treatment with ARAZLO, you should apply one in the morning and one in the evening to separate the application time.</li>\n<li>Do not get ARAZLO in your eyes, the corners of your nose, or in your mouth. If ARAZLO gets in your eyes, rinse them well with water. Call your healthcare provider or get medical help if you have eye irritation that does not go away.</li>\n<li>Wash your hands after applying ARAZLO.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">What should I avoid during treatment with ARAZLO?</span>\n</p>\n<ul>\n<li>Avoid sunlight, including sunlamps during treatment with ARAZLO. ARAZLO can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen and wear a wide-brimmed hat and clothes that cover your skin if you have to be in sunlight.</li>\n<li>Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry.</li>\n<li>Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of ARAZLO?</span>\n</p>\n<p>\n<span class=\"Bold\">ARAZLO may cause serious side effects, including:</span>\n</p>\n<ul>\n<li>See,\n \n <span class=\"Bold\">“What is the most important information I should know about ARAZLO?”</span>\n</li>\n<li>\n<span class=\"Bold\">Skin irritation.</span>ARAZLO may cause application site skin pain, dryness, flaking or peeling, redness, and itching. Tell your healthcare provider if you develop any skin irritation during treatment with ARAZLO. If you develop any of these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you apply ARAZLO, or completely stop treatment with ARAZLO. Also, wind or cold weather may be more irritating to your skin during treatment with ARAZLO.\n \n </li>\n<li>\n<span class=\"Bold\">Sensitivity to sunlight and risk of sunburn.</span>See, “What should I avoid during treatment with ARAZLO?”\n \n </li>\n<li>\n<span class=\"Bold\">The most common side effects of ARAZLO include</span>skin pain, dryness, peeling, redness, and itching.\n \n </li>\n</ul>\n<p>These are not all the possible side effects of ARAZLO.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store ARAZLO?</span>\n</p>\n<ul>\n<li>Store ARAZLO at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>Do not freeze.</li>\n</ul>\n<p>\n<span class=\"Bold\">Keep ARAZLO and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of ARAZLO.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ARAZLO for a condition for which it was not prescribed. Do not give ARAZLO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ARAZLO that is written for health professionals.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in ARAZLO?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span>tazarotene\n \n </p>\n<p>\n<span class=\"Bold\">Inactive ingredients:</span>carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%\n \n </p>\n<p>\n<span class=\"Bold\">Distributed by:</span>Bausch Health US, LLC, Bridgewater, NJ 08807 USA\n \n </p>\n<p>\n<span class=\"Bold\">Manufactured by:</span>Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada \n <br/> Patented. See https://patents.ortho-dermatologics.com for US patent information.\n \n </p>\n<p>ARAZLO is a trademark of Bausch Health Companies Inc. or its affiliates.</p>\n<p>© 2023 Bausch Health Companies Inc. or its affiliates</p>\n<p>For more information, call 1-800-321-4576.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "This Patient Information has been approved by the U.S. Food and Drug Administration. \n Revised: 08/2023 \n 9701202\n " ], "text": "" }

NDC0187-2098-45

{ "type": "p", "children": [], "text": "\nNDC0187-2098-45\n\n " }

For Topical Use Only Not For Eye Use Rx only

{ "type": "p", "children": [], "text": "\nFor Topical Use Only\n\nNot For Eye Use\n\nRx only\n" }

ARAZLO® (tazarotene) Lotion, 0.045%

{ "type": "p", "children": [], "text": "\nARAZLO®\n\n(tazarotene) Lotion, 0.045%\n" }

Net Wt. 45 g

{ "type": "p", "children": [], "text": "\nNet Wt. 45 g\n" }

OrthoDermatologics

{ "type": "p", "children": [], "text": "\nOrthoDermatologics\n\n " }

Tazarotene Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

{ "type": "p", "children": [], "text": "Tazarotene Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older." }

Tazarotene Foam is for topical use only. Tazarotene Foam is not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "Tazarotene Foam is for topical use only. Tazarotene Foam is not for oral, ophthalmic, or intravaginal use." }

Tazarotene Foam should be applied once daily in the evening after washing with a mild cleanser and fully drying the affected area. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears. Avoid the eyes, lips, and mucous membranes. Wash hands after application.

{ "type": "p", "children": [], "text": "Tazarotene Foam should be applied once daily in the evening after washing with a mild cleanser and fully drying the affected area. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears. Avoid the eyes, lips, and mucous membranes. Wash hands after application." }

Patients may use moisturizer as needed.

{ "type": "p", "children": [], "text": "Patients may use moisturizer as needed." }

If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides. Treatment should be discontinued if irritation persists.

{ "type": "p", "children": [], "text": "If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides. Treatment should be discontinued if irritation persists." }

0.1%, white to off-white foam

{ "type": "p", "children": [], "text": "0.1%, white to off-white foam" }

Tazarotene Foam is contraindicated in pregnancy.

{ "type": "p", "children": [], "text": "Tazarotene Foam is contraindicated in pregnancy." }

Tazarotene Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1, 8.3)].

{ "type": "p", "children": [], "text": "\nTazarotene Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1, 8.3)].\n" }

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].

{ "type": "p", "children": [], "text": "\nIf this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].\n" }

Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology (12)].

There were 5 reported pregnancies in subjects who participated in clinical trials for topical tazarotene foam. One of the subjects was found to have been treated with topical tazarotene for 25 days, 2 were treated with vehicle foam, and the other 2 did not receive either tazarotene foam or vehicle foam. The subjects were discontinued from the trials when their pregnancy was reported. The one pregnant woman who was inadvertently exposed to topical tazarotene during the clinical trial delivered a full-term healthy infant.

Females of Childbearing Potential:

Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene foam is used. The possibility of pregnancy should be considered in females of child-bearing potential at the time of institution of therapy.

A negative serum or urine result for pregnancy test having a sensitivity down to at least 25 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to therapy with Tazarotene Foam, which should begin during a normal menstrual period for females of childbearing potential. Advise patients of the need to use an effective method of contraception to avoid pregnancy [see Use in Specific Populations (8.1, 8.3)].

Tazarotene Foam should be used with caution in patients with a history of local tolerability reactions or local hypersensitivity. Retinoids should not be used on abraded or eczematous skin, as they may cause severe irritation. Contact with the mouth, eyes, and mucous membranes should be avoided. In case of accidental contact, rinse well with water.

Some individuals may experience skin redness, peeling, burning or excessive pruritus. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced to an interval the patient can tolerate. However, efficacy at reduced frequency of application has not been established.

Weather extremes, such as wind or cold, may be more irritating to patients using Tazarotene Foam.

Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided. Patients must be warned to use sunscreens and protective clothing when using Tazarotene Foam. Patients with sunburn should be advised not to use Tazarotene Foam until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using Tazarotene Foam and ensure that the precautions are observed [see FDA-approved patient labeling]. Due to the potential for photosensitivity resulting in greater risk for sunburn, Tazarotene Foam should be used with caution in patients with a personal or family history of skin cancer.

Tazarotene Foam should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

The propellant in Tazarotene Foam is flammable. Instruct the patient to avoid fire, flame, and/or smoking during and immediately following application.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data reflect exposure to Tazarotene Foam in 744 subjects with acne vulgaris. Subjects were aged 12 to 45 years and were treated once daily in the evening for 12 weeks. Adverse reactions reported in ≥ 1% of subjects treated with Tazarotene Foam are presented in Table 1. Most adverse reactions were mild to moderate in severity. Severe adverse reactions represented 3.0% of the subjects treated. Overall, 2.7% (20/744) of subjects discontinued Tazarotene Foam because of local skin reactions.

<div class="scrollingtable"><table width="70%"> <caption> <span>Table 1. Incidence of Adverse Reactions in ≥1 % of Subjects Treated with Tazarotene Foam</span> </caption> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">Tazarotene Foam<br/>N = 744</th><th align="center" class="Rrule">Vehicle Foam<br/>N = 741</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Patients with any adverse reaction, n (%)</td><td align="center" class="Rrule">163 (22)</td><td align="center" class="Rrule">19 (3)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site irritation</td><td align="center" class="Rrule">107 (14)</td><td align="center" class="Rrule">9 (1)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site dryness</td><td align="center" class="Rrule">50 (7)</td><td align="center" class="Rrule">8 (1)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site erythema</td><td align="center" class="Rrule">48 (6)</td><td align="center" class="Rrule">3 (&lt;1)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site exfoliation</td><td align="center" class="Rrule">44 (6)</td><td align="center" class="Rrule">3 (&lt;1)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site pain</td><td align="center" class="Rrule">9 (1)</td><td align="center" class="Rrule">0</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site photosensitivity (including sunburn)</td><td align="center" class="Rrule">8 (1)</td><td align="center" class="Rrule">3 (&lt;1)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Application site pruritus</td><td align="center" class="Rrule">7 (1)</td><td align="center" class="Rrule">3 (&lt;1)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Application site dermatitis</td><td align="center" class="Rrule">6 (1)</td><td align="center" class="Rrule">1 (&lt;1)</td> </tr> </tbody> </table></div>

Additional adverse reactions that were reported in <1% of subjects treated with Tazarotene Foam included application site reactions (including discoloration, discomfort, edema, rash, and swelling), dermatitis, impetigo, and pruritus.

Local skin reactions, dryness, erythema, and peeling actively assessed by the investigator and burning/stinging and itching reported by the subject were evaluated at baseline, during treatment, and end of treatment. During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter with the continued use of Tazarotene Foam.

No formal drug-drug interaction studies were conducted with Tazarotene Foam.

{ "type": "p", "children": [], "text": "No formal drug-drug interaction studies were conducted with Tazarotene Foam." }

Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is recommended to postpone treatment until the effects of these products subside before use of Tazarotene Foam is started.

{ "type": "p", "children": [], "text": "Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is recommended to postpone treatment until the effects of these products subside before use of Tazarotene Foam is started." }

Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene. If combination therapy is required, they should be applied at different times of the day (e.g., one in the morning and the other in the evening).

{ "type": "p", "children": [], "text": "Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene. If combination therapy is required, they should be applied at different times of the day (e.g., one in the morning and the other in the evening)." }

The impact of tazarotene on the pharmacokinetics of progestin-only oral contraceptives (i.e., minipills) has not been evaluated.

{ "type": "p", "children": [], "text": "The impact of tazarotene on the pharmacokinetics of progestin-only oral contraceptives (i.e., minipills) has not been evaluated." }

In a trial of 27 healthy female subjects between the ages of 20 to 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

{ "type": "p", "children": [], "text": "In a trial of 27 healthy female subjects between the ages of 20 to 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle." }

Tazarotene Foam is contraindicated in pregnancy [see Contraindications (4)].

There are no adequate and well -controlled studies with Tazarotene Foam in pregnant women. Tazarotene Foam is contraindicated in females who are or may become pregnant [see Contraindications (4)]. Females of child-bearing potential should be warned of the potential risk and use of adequate birth-control measures when Tazarotene Foam is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative serum or urine result for pregnancy test having a sensitivity down to at least 25 mlU/mL for hCG should be obtained within 2 weeks prior to therapy with Tazarotene Foam, which should begin during a normal menstrual period for females of childbearing potential.

In rats, tazarotene 0.05% gel administered topically during gestation days 6 through 17 at 0.25 mg/kg/day resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.

Systemic exposure (AUC) to tazarotenic acid at topical doses of 0.25 mg/kg/day tazarotene in a gel formulation in rats and rabbits were 15 to 166 times, respectively, the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface acrea.

A with other retinoids, when tazarotene was administered orally to experimental animals, developmental delays were seen in rats, and teratogenic effects and post-implantation loss were observed in rats and rabbits at doses 13 and 325 times, respectively, the AUC to tazarotenic acid in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

In female rats orally administered 2 mg/kg/day tazarotene from 15 days before mating through gestation day 7, a number of classic developmental effects of retinoids were observed including decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights. A low incidence of retinoid-related malformations was also observed. AUC in rats was 42 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

After single topical doses of 14C-tazarotene to the skin of lactating rats, radioactivity was detected in milk, suggesting that there would be transfer of drug-related material to the offspring via milk. It is not known whether this drug is excreted in human milk. The safe use of Tazarotene Foam during lactation has not been established. A decision should be made whether to discontinue breastfeeding or to discontinue therapy with Tazarotene Foam taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

The safety and effectiveness of Tazarotene Foam in pediatric patients younger than 12 years have not been established. Clinical studies of Tazarotene Foam included 860 patients aged 12 to 17 years with acne vulgaris.

Tazarotene Foam for the treatment of acne has not been clinically evaluated in persons over the age of 65.

Excessive topical application of Tazarotene Foam may lead to marked redness, peeling, or discomfort. [see Warnings and Precautions (5.2)]. Management of accidental ingestion or excessive application to the skin should be as clinically indicated.

{ "type": "p", "children": [], "text": "Excessive topical application of Tazarotene Foam may lead to marked redness, peeling, or discomfort. [see Warnings and Precautions (5.2)]. Management of accidental ingestion or excessive application to the skin should be as clinically indicated." }

Tazarotene (tazarotene) Foam, 0.1% contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical use only.

{ "type": "p", "children": [], "text": "Tazarotene (tazarotene) Foam, 0.1% contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical use only." }

Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The structural formula is represented below:

{ "type": "p", "children": [], "text": "Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The structural formula is represented below:" }

         Molecular Formula: C21H21NO2S Molecular Weight: 351.46

{ "type": "p", "children": [], "text": "         Molecular Formula: C21H21NO2S Molecular Weight: 351.46" }

Tazarotene is a pale yellow to yellow substance. Tazarotene Foam contains tazarotene, 1 mg/g, in aqueous-based white to off-white foam vehicle consisting of butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. Tazarotene Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.

{ "type": "p", "children": [], "text": "Tazarotene is a pale yellow to yellow substance. Tazarotene Foam contains tazarotene, 1 mg/g, in aqueous-based white to off-white foam vehicle consisting of butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. Tazarotene Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant." }

Tazarotene is a retinoid prodrug that is converted to its active form, the cognate carboxylic acid of tazarotene, by rapid deesterification in animals and man. Tazarotenic acid binds to all 3 members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ but shows relative selectivity for RARβ and RARγ and may modify gene expression. The clinical significance of these findings is unknown.

The mechanism of tazarotene action in acne vulgaris is not defined. However, the basis of tazarotene's therapeutic effect in acne may be due to its anti-hyperproliferative, normalizing-of-differentiation and anti-inflammatory effects. Tazarotene inhibited corneocyte accumulation in rhino mouse skin and cross- linked envelope formation in cultured human keratinocytes. The clinical significance of these findings is unknown.

The pharmacodynamics of Tazarotene Foam are unknown.

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Tazarotenic acid was highly bound to plasma proteins (greater than 99%). Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones, and other polar metabolites which were eliminated through urinary and fecal pathways.

Systemic exposure following topical application of Tazarotene Foam 0.1% was evaluated in one trial. Patients aged 15 years and older with moderate-to-severe acne applied approximately 3.7 grams of Tazarotene Foam 0.1% (N = 13) to approximately 15% body surface area (face, upper chest, upper back, and shoulders) once daily for 22 days. On Day 22, the mean (±SD) tazarotenic acid Cmax was 0.43 (±0.19) ng/mL, the AUC0-24h was 6.98 (±3.56) ng∙h/mL, and the half-life was 21.7 (±15.7) hours. The median Tmax was 6 hours (range: 4.4 to 12 hours). The AUC0-24h for tazarotenic acid was approximately 50-fold higher compared with the parent compound tazarotene. The mean (±SD) half-life of tazarotene was 8.1 (±3.7) hours.

Accumulation was observed upon repeated once-daily dosing as the tazarotenic acid predose concentrations were measurable in the majority of subjects. Steady state was attained within 22 days of daily application. Once-daily dosing resulted in little to no accumulation of tazarotene as predose concentrations were mostly below the quantitation limit throughout the study.

Carcinogenesis:

A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risk. Based on pharmacokinetic data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in rats approximately 2 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

A long-term topical application study of up to 0.1% tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared with vehicle control animals. AUC at the highest dose in mice was 49 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

In evaluation of photocarcinogenicity, median time to onset of tumors was decreased and the number of tumors increased in hairless mice following chronic topical dosing with exposure to ultraviolet radiation at tazarotene concentrations of 0.001%, 0.005%, and 0.01% in a gel formulation for up to 40 weeks.

Mutagenesis:

Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.

Impairment of Fertility:

No impairment of fertility was observed in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure at the 0.125 mg/kg/day dose in rats would be equivalent to 7.6 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene. AUC at the highest dose in rats was 23 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

No effect on parameters of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral doses of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose [see Pregnancy (8.1)]. AUC at the highest dose in rats was 42 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

Reproductive capabilities of F1 animals, including F2 survival and development, were not affected by topical administration of tazarotene gel to female F0 parental rats from gestation day 16 through lactation day 20 at the maximum tolerated dose of 0.125 mg/kg/day. Based on data from another study, the AUC in rats would be equivalent to 7.6 times the AUC in acne patients treated with 2 mg/cm2 of Tazarotene Foam 0.1% over a 15% body surface area.

In 2 multi-center, randomized, double-blind, vehicle-controlled trials, a total of 1,485 subjects with moderate-to-severe acne vulgaris were randomized 1:1 to Tazarotene Foam or vehicle applied once daily for 12 weeks. Acne severity was evaluated using lesion counts and the 6-point Investigator's Global Assessment (IGA) scale (see Table 2). At baseline, 80% of subjects were graded as "moderate" or Grade 3 and 20% were graded as "severe" or Grade 4 on the IGA scale. At baseline, subjects had an average of 79.8 total lesions of which the mean number of inflammatory lesions was 31.9 and the mean number of non-inflammatory lesions was 47.8. Subjects ranged in age from 12 to 45 years, with 860 (58%) subjects aged 12 to 17 years; 428 (29%) subjects aged 18 to 25 years; 143 (10%) subjects aged 26 to 35 years and 54 (4%) subjects aged 36 to 45 years. Subjects enrolled in the trials by race were white (77%), black (15%), Asian (4%), and other (4%). Hispanics comprised 18% of the population. An equal number of males (49%) and females (51%) were enrolled. Treatment success was defined as a score of "clear" (Grade 0) or "almost clear" (Grade 1) and at least 2-grade improvement from the baseline score to Week 12.

{ "type": "p", "children": [], "text": "In 2 multi-center, randomized, double-blind, vehicle-controlled trials, a total of 1,485 subjects with moderate-to-severe acne vulgaris were randomized 1:1 to Tazarotene Foam or vehicle applied once daily for 12 weeks. Acne severity was evaluated using lesion counts and the 6-point Investigator's Global Assessment (IGA) scale (see Table 2). At baseline, 80% of subjects were graded as \"moderate\" or Grade 3 and 20% were graded as \"severe\" or Grade 4 on the IGA scale. At baseline, subjects had an average of 79.8 total lesions of which the mean number of inflammatory lesions was 31.9 and the mean number of non-inflammatory lesions was 47.8. Subjects ranged in age from 12 to 45 years, with 860 (58%) subjects aged 12 to 17 years; 428 (29%) subjects aged 18 to 25 years; 143 (10%) subjects aged 26 to 35 years and 54 (4%) subjects aged 36 to 45 years. Subjects enrolled in the trials by race were white (77%), black (15%), Asian (4%), and other (4%). Hispanics comprised 18% of the population. An equal number of males (49%) and females (51%) were enrolled. Treatment success was defined as a score of \"clear\" (Grade 0) or \"almost clear\" (Grade 1) and at least 2-grade improvement from the baseline score to Week 12." }

<div class="scrollingtable"><table width="70%"> <caption> <span>Table 2. Investigator's Global Assessment Scale</span> </caption> <col align="center" valign="top" width="10%"/> <col align="left" valign="top" width="10%"/> <col align="left" valign="top" width="80%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Grade</th><th align="center" class="Rrule" colspan="2">Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">0</td><td align="left" class="Rrule">Clear</td><td align="left" class="Rrule">Clear skin with no inflammatory or non-inflammatory lesions.</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">1</td><td align="left" class="Rrule">Almost clear</td><td align="left" class="Rrule">Rare non-inflammatory lesions with no more than rare papules.</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">2</td><td align="left" class="Rrule">Mild</td><td align="left" class="Rrule">Greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions).</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">3</td><td align="left" class="Rrule">Moderate</td><td align="left" class="Rrule">Greater than Grade 2, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">4</td><td align="left" class="Rrule">Severe</td><td align="left" class="Rrule">Greater than Grade 3, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions.</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">5</td><td align="left" class="Rrule">Very severe</td><td align="left" class="Rrule">Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"70%\">\n<caption>\n<span>Table 2. Investigator's Global Assessment Scale</span>\n</caption>\n<col align=\"center\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"80%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\">Grade</th><th align=\"center\" class=\"Rrule\" colspan=\"2\">Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\">0</td><td align=\"left\" class=\"Rrule\">Clear</td><td align=\"left\" class=\"Rrule\">Clear skin with no inflammatory or non-inflammatory lesions.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">1</td><td align=\"left\" class=\"Rrule\">Almost clear</td><td align=\"left\" class=\"Rrule\">Rare non-inflammatory lesions with no more than rare papules.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">2</td><td align=\"left\" class=\"Rrule\">Mild</td><td align=\"left\" class=\"Rrule\">Greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions).</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">3</td><td align=\"left\" class=\"Rrule\">Moderate</td><td align=\"left\" class=\"Rrule\">Greater than Grade 2, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">4</td><td align=\"left\" class=\"Rrule\">Severe</td><td align=\"left\" class=\"Rrule\">Greater than Grade 3, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\">5</td><td align=\"left\" class=\"Rrule\">Very severe</td><td align=\"left\" class=\"Rrule\">Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.</td>\n</tr>\n</tbody>\n</table></div>" }

Absolute and percent reductions in lesion counts and the IGA scale after 12 weeks of treatment in these 2 trials are shown in Table 3. Each trial needed to have a statistically significant reduction in 2 out of 3 lesion counts at Week 12.

{ "type": "p", "children": [], "text": "Absolute and percent reductions in lesion counts and the IGA scale after 12 weeks of treatment in these 2 trials are shown in Table 3. Each trial needed to have a statistically significant reduction in 2 out of 3 lesion counts at Week 12." }

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 3. Reductions in Lesion Counts and Improvements in Investigator's Global Assessment at Week 12</span> </caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <thead> <tr class="Botrule First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule" colspan="2">Trial 1</th><th align="center" class="Rrule" colspan="2">Trial 2</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"></th><th align="center">Tazarotene Foam<br/>N = 371</th><th align="center" class="Rrule">Vehicle Foam<br/>N = 372</th><th align="center">Tazarotene Foam<br/>N = 373</th><th align="center" class="Rrule">Vehicle Foam<br/>N = 369</th> </tr> </thead> <tbody> <tr class="First"> <td align="left" class="Lrule Rrule"><span class="Bold">Inflammatory Lesions</span></td><td align="center"></td><td align="center" class="Rrule"></td><td align="center"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Mean absolute reduction from Baseline</td><td align="center">18.0</td><td align="center" class="Rrule">14.0</td><td align="center">18.0</td><td align="center" class="Rrule">15.0</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Mean percent reduction from Baseline</td><td align="center">58%</td><td align="center" class="Rrule">45%</td><td align="center">55%</td><td align="center" class="Rrule">45%</td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Non-inflammatory Lesions</span></td><td align="center"></td><td align="center" class="Rrule"></td><td align="center"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Mean absolute reduction from Baseline</td><td align="center">28.0</td><td align="center" class="Rrule">17.0</td><td align="center">26.0</td><td align="center" class="Rrule">18.0</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Mean percent reduction from Baseline</td><td align="center">55%</td><td align="center" class="Rrule">33%</td><td align="center">57%</td><td align="center" class="Rrule">41%</td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Total Lesions</span></td><td align="center"></td><td align="center" class="Rrule"></td><td align="center"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Mean absolute reduction from Baseline</td><td align="center">46.0</td><td align="center" class="Rrule">31.0</td><td align="center">43.0</td><td align="center" class="Rrule">33.0</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Mean percent reduction from Baseline</td><td align="center">56%</td><td align="center" class="Rrule">39%</td><td align="center">56%</td><td align="center" class="Rrule">43%</td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Investigator's Global Assessment (IGA),</span></td><td align="center"></td><td align="center" class="Rrule"></td><td align="center"></td><td align="center" class="Rrule"></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  n (%) Minimum 2-Dgrade improvement <span class="Italics">and</span> IGA of 0 or 1</td><td align="center" valign="bottom">107 (29%)</td><td align="center" class="Rrule" valign="bottom">60 (16%)</td><td align="center" valign="bottom">103 (28%)</td><td align="center" class="Rrule" valign="bottom">49 (13%)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"80%\">\n<caption>\n<span>Table 3. Reductions in Lesion Counts and Improvements in Investigator's Global Assessment at Week 12</span>\n</caption>\n<col align=\"left\" valign=\"top\" width=\"40%\"/>\n<col align=\"center\" valign=\"top\" width=\"15%\"/>\n<col align=\"center\" valign=\"top\" width=\"15%\"/>\n<col align=\"center\" valign=\"top\" width=\"15%\"/>\n<col align=\"center\" valign=\"top\" width=\"15%\"/>\n<thead>\n<tr class=\"Botrule First\">\n<th align=\"left\" class=\"Lrule Rrule\"></th><th align=\"center\" class=\"Rrule\" colspan=\"2\">Trial 1</th><th align=\"center\" class=\"Rrule\" colspan=\"2\">Trial 2</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Lrule Rrule\"></th><th align=\"center\">Tazarotene Foam<br/>N = 371</th><th align=\"center\" class=\"Rrule\">Vehicle Foam<br/>N = 372</th><th align=\"center\">Tazarotene Foam<br/>N = 373</th><th align=\"center\" class=\"Rrule\">Vehicle Foam<br/>N = 369</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Inflammatory Lesions</span></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\">Mean absolute reduction from Baseline</td><td align=\"center\">18.0</td><td align=\"center\" class=\"Rrule\">14.0</td><td align=\"center\">18.0</td><td align=\"center\" class=\"Rrule\">15.0</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Mean percent reduction from Baseline</td><td align=\"center\">58%</td><td align=\"center\" class=\"Rrule\">45%</td><td align=\"center\">55%</td><td align=\"center\" class=\"Rrule\">45%</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Non-inflammatory Lesions</span></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\">Mean absolute reduction from Baseline</td><td align=\"center\">28.0</td><td align=\"center\" class=\"Rrule\">17.0</td><td align=\"center\">26.0</td><td align=\"center\" class=\"Rrule\">18.0</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Mean percent reduction from Baseline</td><td align=\"center\">55%</td><td align=\"center\" class=\"Rrule\">33%</td><td align=\"center\">57%</td><td align=\"center\" class=\"Rrule\">41%</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Total Lesions</span></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\">Mean absolute reduction from Baseline</td><td align=\"center\">46.0</td><td align=\"center\" class=\"Rrule\">31.0</td><td align=\"center\">43.0</td><td align=\"center\" class=\"Rrule\">33.0</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Mean percent reduction from Baseline</td><td align=\"center\">56%</td><td align=\"center\" class=\"Rrule\">39%</td><td align=\"center\">56%</td><td align=\"center\" class=\"Rrule\">43%</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Investigator's Global Assessment (IGA),</span></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\"></td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">  n (%) Minimum 2-Dgrade improvement <span class=\"Italics\">and</span> IGA of 0 or 1</td><td align=\"center\" valign=\"bottom\">107 (29%)</td><td align=\"center\" class=\"Rrule\" valign=\"bottom\">60 (16%)</td><td align=\"center\" valign=\"bottom\">103 (28%)</td><td align=\"center\" class=\"Rrule\" valign=\"bottom\">49 (13%)</td>\n</tr>\n</tbody>\n</table></div>" }

How Supplied:

Tazarotene Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:

<div class="scrollingtable"><table class="Noautorules" width="50%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left">50-g aluminum can</td><td align="left">NDC 68308-685-50</td> </tr> </tbody> </table></div>

Storage and Handling:

See FDA-approved patient labeling (Patient Information).

{ "type": "p", "children": [], "text": "See FDA-approved patient labeling (Patient Information)." }

Inform the patient of the following:

{ "type": "p", "children": [], "text": "Inform the patient of the following:" }

{ "type": "ul", "children": [ "Fetal risk associated with Tazarotene Foam for females of childbearing potential. Advise patients to use an effective method of contraception during treatment to avoid pregnancy. Advise the patient to stop medication if she becomes pregnant and call her doctor.", "If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides.", "Do not place Tazarotene Foam in the freezer.", "Avoid exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.", "Avoid contact with the eyes. If Tazarotene Foam gets in or near their eyes, to rinse thoroughly with water.", "Wash their hands after applying Tazarotene Foam.", "Avoid fire, flame, or smoking during and immediately following application since Tazarotene Foam is flammable.", "Keep out of the reach of children.", "Not for ophthalmic, oral, or intravaginal use." ], "text": "" }

Distributed by: Mayne Pharma Raleigh, NC 27609

{ "type": "p", "children": [], "text": "Distributed by:\nMayne Pharma\nRaleigh, NC 27609" }

141190

{ "type": "p", "children": [], "text": "141190" }

Pharmacist-Detach here and Give Instructions to Patient

{ "type": "p", "children": [], "text": "Pharmacist-Detach here and Give Instructions to Patient" }

Tazarotene Foam

{ "type": "p", "children": [], "text": "\nTazarotene Foam\n" }

IMPORTANT: For skin use only. Do not get Tazarotene Foam in your eyes, mouth, or vagina.

{ "type": "p", "children": [], "text": "\nIMPORTANT: For skin use only. Do not get Tazarotene Foam in your eyes, mouth, or vagina.\n" }

Read the Patient Information that comes with Tazarotene Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

{ "type": "p", "children": [], "text": "Read the Patient Information that comes with Tazarotene Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment." }

What is Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nWhat is Tazarotene Foam?\n" }

Tazarotene Foam is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.

{ "type": "p", "children": [], "text": "Tazarotene Foam is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older." }

It is not known if Tazarotene Foam is safe and effective in children under 12 years of age.

{ "type": "p", "children": [], "text": "It is not known if Tazarotene Foam is safe and effective in children under 12 years of age." }

Who should not use Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nWho should not use Tazarotene Foam?\n" }

Do not use Tazarotene Foam if you are pregnant or plan to become pregnant. Tazarotene Foam may harm your unborn baby, if used during pregnancy.

{ "type": "p", "children": [], "text": "\nDo not use Tazarotene Foam if you are pregnant or plan to become pregnant. Tazarotene Foam may harm your unborn baby, if used during pregnancy." }

If you are a female who can become pregnant:

{ "type": "p", "children": [], "text": "\nIf you are a female who can become pregnant:\n" }

{ "type": "ul", "children": [ "Use an effective method of birth control during treatment with Tazarotene Foam. Talk with your doctor about birth control methods that are right for you during treatment with Tazarotene Foam.", "Your doctor should do a blood or urine pregnancy test within 2 weeks before you begin to use Tazarotene Foam to be sure you are not pregnant.", "If you have menstrual periods, begin using Tazarotene Foam during a normal menstrual period to help assure that you are not pregnant when you begin use." ], "text": "" }

Stop using Tazarotene Foam and call your doctor right away if you become pregnant during treatment with Tazarotene Foam.

{ "type": "p", "children": [], "text": "\nStop using Tazarotene Foam and call your doctor right away if you become pregnant during treatment with Tazarotene Foam.\n" }

What should I tell my doctor before using Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nWhat should I tell my doctor before using Tazarotene Foam?\n" }

Before you use Tazarotene Foam, tell your doctor if you:

{ "type": "p", "children": [], "text": "\nBefore you use Tazarotene Foam, tell your doctor if you:\n" }

{ "type": "ul", "children": [ "or a family member have or had skin cancer.", "have eczema.", "have had a reaction to topical products in the past.", "have any condition that makes you sensitive to light.", "have any other medical conditions.", "are pregnant or plan to become pregnant. See \"Who should not use Tazarotene Foam?\"\n", "are breastfeeding or plan to breastfeed. It is not known if tazarotene passes into your breast milk. You and your doctor should decide if you will use Tazarotene Foam or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you use Tazarotene Foam." ], "text": "" }

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements.

{ "type": "p", "children": [], "text": "\nTell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements." }

Especially tell your doctor if you:

{ "type": "p", "children": [], "text": "Especially tell your doctor if you:" }

{ "type": "ul", "children": [ "use other medicines or products that make your skin dry", "take other medicines that may increase your sensitivity to sunlight" ], "text": "" }

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

{ "type": "p", "children": [], "text": "Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above." }

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

{ "type": "p", "children": [], "text": "Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine." }

How should I use Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nHow should I use Tazarotene Foam?\n" }

{ "type": "ul", "children": [ "Use Tazarotene Foam exactly as your doctor tells you to. Do not use more Tazarotene Foam than prescribed and do not use it more often than your doctor tells you to.", "If you are a female and have menstrual periods, begin using Tazarotene Foam during a normal menstrual period to help assure that you are not pregnant when you begin use. See \"Who should not use Tazarotene Foam?\"\n", "Tazarotene Foam is flammable. Avoid fire, flame, and smoking during and right after you apply Tazarotene Foam.", "Gently clean the affected area (face and/or upper trunk) with a mild cleanser and dry completely before using Tazarotene Foam.", "Apply Tazarotene Foam one time each day, before going to bed, to the affected areas (face and/or upper trunk) where you have acne lesions. Use enough foam to cover the entire affected area with a thin film of Tazarotene Foam.", "Keep Tazarotene Foam away from your eyes, mouth, and vagina. If Tazarotene Foam comes into contact with your eyes, rinse them well with water.", "Wash your hands after applying Tazarotene Foam.", "If you use too much Tazarotene Foam, you may get redness, peeling, or skin irritation in the treated area. Call your doctor if this happens, or if you accidentally swallow Tazarotene Foam.", "Follow your doctor's directions for other routine skin care and the use of make-up.", "You may also use a moisturizer as needed." ], "text": "" }

Instructions for applying Tazarotene Foam

{ "type": "p", "children": [], "text": "\nInstructions for applying Tazarotene Foam\n" }

1. Shake the Tazarotene Foam can before use.

{ "type": "p", "children": [], "text": "1. Shake the Tazarotene Foam can before use." }

2. Remove cap from can. See Figure A.

{ "type": "p", "children": [], "text": "2. Remove cap from can. See Figure A." }

Figure A

{ "type": "p", "children": [], "text": "\nFigure A" }

3. Hold the Tazarotene Foam can upright at a slight angle and press the nozzle. See Figure B.

{ "type": "p", "children": [], "text": "3. Hold the Tazarotene Foam can upright at a slight angle and press the nozzle. See Figure B." }

Figure B

{ "type": "p", "children": [], "text": "\nFigure B" }

4. Dispense a small amount of Tazarotene Foam into the palm of your hand. See Figure C.

{ "type": "p", "children": [], "text": "4. Dispense a small amount of Tazarotene Foam into the palm of your hand. See Figure C." }

Figure C

{ "type": "p", "children": [], "text": "\nFigure C" }

5. Use the fingertips of your other hand to apply enough Tazarotene Foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin. See Figure D.

{ "type": "p", "children": [], "text": "5. Use the fingertips of your other hand to apply enough Tazarotene Foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin. See Figure D." }

Figure D

{ "type": "p", "children": [], "text": "\nFigure D" }

6. Wash hands after applying Tazarotene Foam. See Figure E.

{ "type": "p", "children": [], "text": "6. Wash hands after applying Tazarotene Foam. See Figure E." }

Figure E

{ "type": "p", "children": [], "text": "\nFigure E" }

Avoid getting Tazarotene Foam in your eyes, mouth, or vagina.

{ "type": "p", "children": [], "text": "Avoid getting Tazarotene Foam in your eyes, mouth, or vagina." }

What should I avoid while using Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nWhat should I avoid while using Tazarotene Foam?\n" }

{ "type": "ul", "children": [ "Avoid using abrasive soaps or cleansers that might dry or irritate your skin, unless your doctor tells you it is ok.", "Avoid sunlight. Tazarotene Foam can make your skin sensitive to sunlight and the light from sunlamps or tanning beds. You could get a sunburn. Use sunscreen and protective clothing during the day if you must be in sunlight.", "Avoid using Tazarotene Foam if you have a sunburn. If you have a sunburn, wait until it is fully healed before using Tazarotene Foam.", "Talk to your doctor before using Tazarotene Foam if you are sensitive to sunlight, take medications that increase your sensitivity to sunlight, or you must spend a lot of time in the sun for your job.", "Avoid weather extremes, such as wind and cold, because they may irritate your skin more while you are using Tazarotene Foam." ], "text": "" }

What are the possible side effects of Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of Tazarotene Foam?\n" }

Tazarotene Foam may harm your unborn baby, if used during pregnancy.

{ "type": "p", "children": [], "text": "\nTazarotene Foam may harm your unborn baby, if used during pregnancy.\n" }

{ "type": "ul", "children": [ "Do not use Tazarotene Foam during pregnancy. See \"Who should not use Tazarotene Foam?\"" ], "text": "" }

The most common side effects of Tazarotene Foam are:

{ "type": "p", "children": [], "text": "The most common side effects of Tazarotene Foam are:" }

{ "type": "ul", "children": [ "burning or stinging", "dry skin", "red skin", "peeling or flaking skin" ], "text": "" }

Sometimes these symptoms can become severe and may be uncomfortable. Tell your doctor if these side effects become uncomfortable for you. Your doctor may tell you to stop using Tazarotene Foam until your skin heals and your symptoms improve, or to use Tazarotene Foam less often to help you tolerate it better.

{ "type": "p", "children": [], "text": "Sometimes these symptoms can become severe and may be uncomfortable. Tell your doctor if these side effects become uncomfortable for you. Your doctor may tell you to stop using Tazarotene Foam until your skin heals and your symptoms improve, or to use Tazarotene Foam less often to help you tolerate it better." }

These are not all the possible side effects of Tazarotene Foam. For more information, ask your doctor or pharmacist.

{ "type": "p", "children": [], "text": "These are not all the possible side effects of Tazarotene Foam. For more information, ask your doctor or pharmacist." }

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

{ "type": "p", "children": [], "text": "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088." }

You may also report side effects to Mayne Pharma at 1-844-825-8500.

{ "type": "p", "children": [], "text": "You may also report side effects to Mayne Pharma at 1-844-825-8500." }

How should I store Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nHow should I store Tazarotene Foam?\n" }

{ "type": "ul", "children": [ "Store Tazarotene Foam at room temperature, between 68°F to 77°F (20°C to 25°C).", "Store Tazarotene Foam upright.", "Do not freeze Tazarotene Foam.", "Tazarotene Foam is flammable. Keep the can away from fire and heat. Do not spray Tazarotene Foam near fire or direct heat.", "Do not puncture the can or throw it into a fire, even if the can is empty." ], "text": "" }

Keep Tazarotene Foam and all medicines out of the reach of children. General Information about Tazarotene Foam

{ "type": "p", "children": [], "text": "\nKeep Tazarotene Foam and all medicines out of the reach of children. General Information about Tazarotene Foam\n" }

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Tazarotene Foam for a condition for which it was not prescribed. Do not give Tazarotene Foam to other people even if they have the same symptoms that you have. It may harm them.

{ "type": "p", "children": [], "text": "Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Tazarotene Foam for a condition for which it was not prescribed. Do not give Tazarotene Foam to other people even if they have the same symptoms that you have. It may harm them." }

This Patient Information leaflet summarizes the most important information about Tazarotene Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Tazarotene Foam that is written for health professionals.

{ "type": "p", "children": [], "text": "This Patient Information leaflet summarizes the most important information about Tazarotene Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Tazarotene Foam that is written for health professionals." }

What are the ingredients in Tazarotene Foam?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in Tazarotene Foam?\n" }

Active ingredient: tazarotene

{ "type": "p", "children": [], "text": "Active ingredient: tazarotene" }

Inactive ingredients: butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.

{ "type": "p", "children": [], "text": "Inactive ingredients: butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant." }

This Patient Information has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration." }

Distributed by: Mayne Pharma Raleigh, NC 27609

{ "type": "p", "children": [], "text": "Distributed by:\nMayne Pharma\nRaleigh, NC 27609" }

03/2023

{ "type": "p", "children": [], "text": "03/2023" }

NDC 68308-685-50

{ "type": "p", "children": [], "text": "NDC 68308-685-50" }

Tazarotene

{ "type": "p", "children": [], "text": "Tazarotene" }

Foam, 0.1%

{ "type": "p", "children": [], "text": "Foam, 0.1%" }

50 grams

{ "type": "p", "children": [], "text": "50 grams" }

Rx onlyFor topical use only

{ "type": "p", "children": [], "text": "Rx onlyFor topical use only" }

STORE UPRIGHT

{ "type": "p", "children": [], "text": "STORE UPRIGHT" }

mayne pharma

{ "type": "p", "children": [], "text": "mayne pharma" }

RecyclableAluminumContainer

{ "type": "p", "children": [], "text": "RecyclableAluminumContainer" }