ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

{ "type": "p", "children": [], "text": "ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older." }

Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently.

{ "type": "p", "children": [], "text": "Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently." }

Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.

{ "type": "p", "children": [], "text": "Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may \n be necessary.\n " }

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 ml) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis {see Warnings and Precautions 5.1].Do not use with occlusive dressings unless directed by a physician.

{ "type": "p", "children": [], "text": "Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 ml) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis {see Warnings and Precautions 5.1].Do not use with occlusive dressings unless directed by a physician." }

ULTRAVATE lotion is for external use only.

{ "type": "p", "children": [], "text": "ULTRAVATE lotion is for external use only." }

Avoid use on the face, scalp, groin, or axillae.

{ "type": "p", "children": [], "text": "Avoid use on the face, scalp, groin, or axillae." }

ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use.

{ "type": "p", "children": [], "text": "ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use." }

ULTRAVATE (halobetasol propionate) lotion, 0.05% is a white to off-white lotion. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate.

{ "type": "p", "children": [], "text": "ULTRAVATE (halobetasol propionate) lotion, 0.05% is a white to off-white lotion. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate." }

None.

{ "type": "p", "children": [], "text": "None." }

ULTRAVATE lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.The potential for hypothalamic-pituitary adrenal (HPA) suppression with ULTRAVATE lotion was evaluated in the following studies:

Because of the potential for systemic absorption, use of topical corticosteroids, including ULTRAVATE lotion, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surtace areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids. Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surtace-to-body mass ratios [see Use in Specific Populations (8.4)].

Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including ULTRAVATE lotion. Some local adverse reactions may be irreversible.

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of ULTRAVATE lotion until the infection has been adequately treated.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue ULTRAVATE lotion if allergic contact dermatitis is established.

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 practice.

During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with ULTRAVATE lotion twice daily for up to two weeks (up to approximately 50 grams/week).

Table 1 presents adverse reactions that occured in at least 1% of subjects treated with ULTRAVATE lotion twice daily for up to two weeks, and more frequently than in vehicle-treated subjects.

<div class="scrollingtable"><table width="65%"> <caption> <span>Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with ULTRAVATE Lotion for up to Two Weeks</span> </caption> <colgroup> <col align="left" valign="middle" width="60%"/> <col align="center" valign="middle" width="20%"/> <col align="center" valign="middle" width="20%"/> </colgroup> <thead> <tr class="Botrule First First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">ULTRAVATE Lotion <br/> (N=277) </th><th align="center" class="Rrule">Vehicle Lotion <br/> (N=259) </th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"><span class="Italics">Adverse Reaction</span></th><th align="center" class="Rrule">%</th><th align="center" class="Rrule">%</th> </tr> </thead> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="3"></td> </tr> </tfoot> <tbody> <tr class="Botrule First First"> <td align="left" class="Lrule Rrule">Telangiectasia</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">0%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Application site atrophy</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">&lt;1%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Headache</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">&lt;1%</td> </tr> </tbody> </table></div>

Less common dverse reactions (incidence less than 1% but greater than 0.1%) that occured in subjects treated with ULTRAVATE lotion included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.

There are no available data on Ultravate lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data]. The clinical relevance of the animal findings is not clear.

The background risk of major birth defects and miscarriage for the indicated population are unknown. 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

Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants.

Animal Data

Halobetasol propionate has been shown to be teratogenic in rats and rabbits when given systemically during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. These doses are approximately 13, 33, and 3 times, respectively, the human topical dose of halobetasol propionate, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats.Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

Risk Summary

There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastted infant, or the effects on milk production after topical application to women who are breastteeding.

Systemically administered corticosteroids appear in human milk and could suppress growth, intertere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastteeding should be considered along with the mother's clinical need for UL TRAVATE lotion and any potentialadverse effects on the breastted infant from ULTRAVATE lotion or from the underlying maternal condition.

Clinical Considerations

Advise breastfeeding women not to apply ULTRAVATE lotion directly to the nipple and areola to avoid direct infant exposure.

Safety and effectiveness of ULTRAVATE lotion for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older. It is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled safety trial in 16 adolescents (12 to less than 17 years of age). Adolescent patients with moderate to severe plaque psoriasis covering a minimum of 10% of the total body surface area were treated twice daily for 2 weeks with ULTRAVATE lotion. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 14 patients. After 2 weeks of treatment, 1 of 14 patients (7%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of sl 8 μg/dL) that recovered upon retest. No other adverse reactions were reported in the study.

Because of higher skin surtace area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Clinical studies with ULTRAVATE lotion included 89 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years. Clinical studies of ULTRAVATE lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Topically applied ULTRAVATE lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Topically applied ULTRAVATE lotion can be absorbed in sufficient amounts to produce systemic effects [see\n \n Warnings and Precautions (5.1)].\n\n " }

ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21­ chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17­ propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C 25H 31ClF 2O 5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula:

{ "type": "p", "children": [], "text": "ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21­ chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17­ propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C\n \n 25H\n \n 31ClF\n \n 2O\n \n 5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula:\n\n " }

Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water.

{ "type": "p", "children": [], "text": "Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water." }

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

Vasoconstriction: A vasoconstrictor assay in healthy subjects with ULTRAVATE lotion indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitaty-Adrenal (HPA) Axis Suppression:

The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH). In the first study, ULTRAVATE lotion was applied to20 adult subjects with moderate to severe plaque psoriasis. A mean dose of 3.5 grams ULTRAVATE lotion was applied twice daily for two weeks and produced HPA axis suppression in 5 of 20 (25%) subjects. The effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment. In the second study, ULTRAVATE lotion was applied to 16 adolescent subjects 12 years to less than 17 years of age with moderate to severe plaque psoriasis affecting a mean body surtace area of 11.5% (range from 10% to 14%). The mean dose was 3.6 grams applied twice daily for two weeks. A subset of 14 of the 16 completed subjects had evaluable ACTH stimulation tests, and HPA axis suppression was observed in 1 of these 14 subjects (7%). In the second study also, the effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

In the HPA clinical study /see Clinical Pharmacology (12.2)1, pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects. Based on the geometric mean plasma concentrations at 12 hours post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) C maxconcentrations for ULTRAVATE lotion on Day 8 was 201.1 ± 157.5 pg/ml, with the corresponding median T maxvalue of 3 hours (range O - 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1632 ± 1147 pg•h/ml.

Specific Populations Pediatric Patients

In the pediatric HPA study [see Clinical Pharmacology (12.2)], trough plasma concentrations of HBP were measured on Day 8 and Day 15 in a subset of 14 subjects. The HBP levels in the plasma were below the quantification limit (20 pg/ml) for all subjects at all time points with the exception of one subject at Day 15 (trough concentration of HBP of 28.2 pg/ml).

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Halobetasol Propionate Topical Foam at dose concentrations from 0.005% to 0.05% or from 0.011 to 0.11 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro.

Studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

ULTRAVATE lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, doble-blind, vehicle-controlled trials.

{ "type": "p", "children": [], "text": "ULTRAVATE lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, doble-blind, vehicle-controlled trials. " }

These trials were conducted in 443 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level global evaluation scale, on which a subject scored either moderate or severe. Overall, 57% of subjects were male and 86% were Caucasian.

{ "type": "p", "children": [], "text": "These trials were conducted in 443 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level global evaluation scale, on which a subject scored either moderate or severe. Overall, 57% of subjects were male and 86% were Caucasian." }

Subjects applied ULTRAVATE lotion or vehicle to all affected areas twice daily for up to 14 consecutive days.

{ "type": "p", "children": [], "text": "Subjects applied ULTRAVATE lotion or vehicle to all affected areas twice daily for up to 14 consecutive days. " }

The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two grade improvement from baseline at Week 2 (end of treatment). Table 2 presents these results.

{ "type": "p", "children": [], "text": "The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two grade improvement from baseline at Week 2 (end of treatment). Table 2 presents these results. " }

<div class="scrollingtable"><table width="65%"> <caption> <span>Table 2: Overall Treatment Success in Subjects with Plaque Psoriasis at Week 2</span> </caption> <colgroup> <col align="left" valign="middle" width="26%"/> <col align="center" valign="middle" width="19%"/> <col align="center" valign="middle" width="18%"/> <col align="center" valign="middle" width="19%"/> <col align="center" valign="middle" width="18%"/> </colgroup> <thead> <tr class="Botrule First First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule" colspan="2" valign="top">Study 1</th><th align="center" class="Rrule" colspan="2" valign="top">Study 2</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">ULTRAVATE Lotion <br/> N=110 </th><th align="center" class="Rrule">Vehicle Lotion <br/> N=76 </th><th align="center" class="Rrule">ULTRAVATE Lotion <br/> N=110 </th><th align="center" class="Rrule">Vehicle Lotion <br/> N=112 </th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Subject whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two grade improvement from baseline. </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First First Last Last"> <td align="left" class="Lrule Rrule">Overall Treatment Success <a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="center" class="Rrule">49 (44.5%)</td><td align="center" class="Rrule">7 (6.3%)</td><td align="center" class="Rrule">49 (44.5%)</td><td align="center" class="Rrule">8 (7.1%)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"65%\">\n<caption>\n<span>Table 2: Overall Treatment Success in Subjects with Plaque Psoriasis at Week 2</span>\n</caption>\n<colgroup>\n<col align=\"left\" valign=\"middle\" width=\"26%\"/>\n<col align=\"center\" valign=\"middle\" width=\"19%\"/>\n<col align=\"center\" valign=\"middle\" width=\"18%\"/>\n<col align=\"center\" valign=\"middle\" width=\"19%\"/>\n<col align=\"center\" valign=\"middle\" width=\"18%\"/>\n</colgroup>\n<thead>\n<tr class=\"Botrule First First\">\n<th align=\"left\" class=\"Lrule Rrule\"></th><th align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">Study 1</th><th align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">Study 2</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"left\" class=\"Lrule Rrule\"></th><th align=\"center\" class=\"Rrule\">ULTRAVATE Lotion\n <br/>\n\t\t\tN=110\n </th><th align=\"center\" class=\"Rrule\">Vehicle Lotion\n <br/>\n\t\t\tN=76\n </th><th align=\"center\" class=\"Rrule\">ULTRAVATE Lotion\n <br/>\n\t\t\tN=110\n </th><th align=\"center\" class=\"Rrule\">Vehicle Lotion\n <br/>\n\t\t\tN=112\n </th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"5\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-1\" name=\"footnote-1\">*</a>\n</dt>\n<dd>Subject whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two grade improvement from baseline. </dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First First Last Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Overall Treatment Success\n <a class=\"Sup\" href=\"#footnote-1\" name=\"footnote-reference-1\">*</a></td><td align=\"center\" class=\"Rrule\">49 (44.5%)</td><td align=\"center\" class=\"Rrule\">7 (6.3%)</td><td align=\"center\" class=\"Rrule\">49 (44.5%)</td><td align=\"center\" class=\"Rrule\">8 (7.1%)</td>\n</tr>\n</tbody>\n</table></div>" }

The secondary measures of efficacy were Treatment Success for individual signs of psoriasis (scaling, erythema, and plaque elevation) at the end of treatment (see Table 3).

{ "type": "p", "children": [], "text": "The secondary measures of efficacy were Treatment Success for individual signs of psoriasis (scaling, erythema, and plaque\n \nelevation) at the end of treatment (see Table 3).\n " }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: Individual Signs Treatment Success in Subjects with Plaque Psoriasis at Week 2</span> </caption> <tfoot> <tr> <td align="left" colspan="0"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>Subjects who were cleared or almost cleared of the designated clinical sign with at least a two grade improvement from baseline. </dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td></td><td colspan="2">Study 1</td><td colspan="2">Study 2</td> </tr> <tr> <td>Treatment Success <a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a></td><td>ULTRAVATE Lotion N=10</td><td>Vehicle Lotion N=111</td><td>ULTRAVATE Lotion N=110</td><td>Vehicle Lotio N=112</td> </tr> <tr> <td>Scaling</td><td>61 (55.5%)</td><td>12 (10.8%)</td><td>65 (59.1%)</td><td>11 (9.8%)</td> </tr> <tr> <td>Erythema</td><td>40 (36.4%)</td><td>8 (7.2%)</td><td>48 (43.6%)</td><td>12 (10.7%)</td> </tr> <tr class="Last"> <td>Plaque Elevation</td><td>50 (45.5%)</td><td>9 (8.1%)</td><td>48 (43.6%)</td><td>9 (8.0%)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 3: Individual Signs Treatment Success in Subjects with Plaque Psoriasis at Week 2</span>\n</caption>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"0\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-2\" name=\"footnote-2\">*</a>\n</dt>\n<dd>Subjects who were cleared or almost cleared of the designated clinical sign with at least a two grade improvement from baseline. </dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td></td><td colspan=\"2\">Study 1</td><td colspan=\"2\">Study 2</td>\n</tr>\n<tr>\n<td>Treatment Success\n <a class=\"Sup\" href=\"#footnote-2\" name=\"footnote-reference-2\">*</a></td><td>ULTRAVATE Lotion N=10</td><td>Vehicle Lotion N=111</td><td>ULTRAVATE Lotion N=110</td><td>Vehicle Lotio N=112</td>\n</tr>\n<tr>\n<td>Scaling</td><td>61 (55.5%)</td><td>12 (10.8%)</td><td>65 (59.1%)</td><td>11 (9.8%)</td>\n</tr>\n<tr>\n<td>Erythema</td><td>40 (36.4%)</td><td>8 (7.2%)</td><td>48 (43.6%)</td><td>12 (10.7%)</td>\n</tr>\n<tr class=\"Last\">\n<td>Plaque Elevation</td><td>50 (45.5%)</td><td>9 (8.1%)</td><td>48 (43.6%)</td><td>9 (8.0%)</td>\n</tr>\n</tbody>\n</table></div>" }

ULTRAVATE lotion, 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 ml (59 g) of ULTRAVATE lotion.

NOC 73159-008-60 60 ml (59 g) bottle

Store at 25'C (77'F); excursions permitted to 15°G and 30°G (59° F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

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)." }

Advise patients using ULTRAVATE lotion of the following information and instructions:

{ "type": "p", "children": [], "text": "Advise patients using ULTRAVATE lotion of the following information and instructions:" }

Important Administration Instructions

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

Instruct patients to discontinue ULTRAVATE lotion when psoriasis is controlled. ULTRAVATE lotion should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks. Inform patients that total dosage should not exceed 50 grams per week [see Dosage and Administration (2)].

{ "type": "p", "children": [], "text": "\nInstruct patients to discontinue ULTRAVATE lotion when psoriasis is controlled. ULTRAVATE lotion should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks. Inform patients that total dosage should not exceed 50 grams per week\n \n [see Dosage and Administration (2)].\n\n " }

Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae [see Dosage and Administration (2)].

{ "type": "p", "children": [], "text": "Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae\n \n [see Dosage and Administration (2)].\n\n " }

Effects on Endocrine System

{ "type": "p", "children": [], "text": "\nEffects on Endocrine System\n" }

UL TRAVATE lotion may cause HPA axis suppression. Advise patients that use of UL TRAVATE lotion, may require periodic evaluation for HPA axis suppression. Advise patients to avoid use of multiple corticosteroid-containing products [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "\nUL TRAVATE lotion may cause HPA axis suppression. Advise patients that use of UL TRAVATE lotion, may require periodic evaluation for HPA axis suppression. Advise patients to avoid use of multiple corticosteroid-containing products\n \n [see Warnings and Precautions (5.1)].\n\n " }

Local Adverse Reactions

{ "type": "p", "children": [], "text": "\nLocal Adverse Reactions\n" }

Inform patients that topical corticosteroids may cause local adverse reactions, some of which may be irreversible. These reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency comcosteroids, including ULTRAVATE lotion [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "\nInform patients that topical corticosteroids may cause local adverse reactions, some of which may be irreversible. These reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency comcosteroids, including ULTRAVATE lotion\n \n [see Warnings and Precautions (5.2)].\n\n " }

Breastteeding women should not apply ULTRAVATE lotion directly to the nipple and areola to avoid directly exposing the infant [see Lactation (8.2)].

{ "type": "p", "children": [], "text": "Breastteeding women should not apply ULTRAVATE lotion directly to the nipple and areola to avoid directly exposing the infant\n \n [see Lactation (8.2)].\n" }

ULTRAVATE is a trademark of Lacer Pharma, LLC Manufactured by: Ferndale Laboratories, Inc., Ferndale, Ml 48220 Distributed by: Lacer Pharma, LLC, Biloxi, MS 39532 U.S. Patent 8,962,028 Document Control No. 69311. Rev.: 0125

{ "type": "p", "children": [], "text": "ULTRAVATE is a trademark of Lacer Pharma, LLC \n Manufactured by: Ferndale Laboratories, Inc., Ferndale, Ml 48220 \n Distributed by: Lacer Pharma, LLC, Biloxi, MS 39532 \n U.S. Patent 8,962,028 \n Document Control No. 69311. \n Rev.: 0125\n " }

NDC 73159-008-60

{ "type": "p", "children": [], "text": "NDC 73159-008-60" }

ULTRAVATE lotion, 0.05%

{ "type": "p", "children": [], "text": "ULTRAVATE lotion, 0.05%" }

For topical use only.

{ "type": "p", "children": [], "text": "For topical use only." }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY" }

Net Wt. 60 mL (59 g) bottle

{ "type": "p", "children": [], "text": "Net Wt. 60 mL (59 g) bottle" }

Halobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

{ "type": "p", "children": [], "text": "\nHalobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.\n" }

Shake can prior to use and turn can completely upside down to dispense. Apply Halobetasol Propionate Topical Foam as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product.

{ "type": "p", "children": [], "text": "Shake can prior to use and turn can completely upside down to dispense. Apply Halobetasol Propionate Topical Foam as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product." }

Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of the diagnosis may be necessary.

{ "type": "p", "children": [], "text": "Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of the diagnosis may be necessary." }

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Do not use with occlusive dressings unless directed by a physician.

{ "type": "p", "children": [], "text": "Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Do not use with occlusive dressings unless directed by a physician." }

Avoid use on the face, groin, or axillae.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae." }

Avoid contact with eyes. Wash hands after each application, unless it is for treatment of the hands.

{ "type": "p", "children": [], "text": "Avoid contact with eyes. Wash hands after each application, unless it is for treatment of the hands." }

Halobetasol propionate topical foam is for topical use only.

{ "type": "p", "children": [], "text": "Halobetasol propionate topical foam is for topical use only." }

Halobetasol propionate topical foam is not for ophthalmic, oral, or intravaginal use.

{ "type": "p", "children": [], "text": "Halobetasol propionate topical foam is not for ophthalmic, oral, or intravaginal use." }

Halobetasol Propionate Topical Foam is a white to off-white topical foam. Each gram of Halobetasol Propionate Topical Foam, 0.05% contains 0.5 mg of halobetasol propionate.

{ "type": "p", "children": [], "text": "Halobetasol Propionate Topical Foam is a white to off-white topical foam. Each gram of Halobetasol Propionate Topical Foam, 0.05% contains 0.5 mg of halobetasol propionate." }

None.

{ "type": "p", "children": [], "text": "None." }

Halobetasol Propionate Topical Foam is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid. The potential for hypothalamic-pituitary-adrenal (HPA) suppression with Halobetasol Propionate Topical Foam was evaluated in the following studies:

Because of the potential for systemic absorption, use of topical corticosteroids, including Halobetasol Propionate Topical Foam, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.

Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios [see Use in Specific Populations (8.4)].

Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Halobetasol Propionate Topical Foam. Some local adverse reactions may be irreversible.

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Halobetasol Propionate Topical Foam until the infection has been adequately treated.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue Halobetasol Propionate Topical Foam if allergic contact dermatitis is established.

Halobetasol Propionate Topical Foam is flammable. Avoid fire, flame, 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with Halobetasol Propionate Topical Foam twice daily for up to two weeks (up to approximately 50 grams per week). Table 1 presents selected adverse reactions that occurred in at least 1% of subjects.

<div class="scrollingtable"><table width="65%"> <caption> <span>Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects through Week 2</span> </caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="30%"/> <col align="center" valign="top" width="30%"/> <thead> <tr class="Botrule First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">HBP Foam<br/>N=351</th><th align="center" class="Rrule">Vehicle Foam<br/>N=353</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"><span class="Italics">Adverse Reaction</span></th><th align="center" class="Rrule">%</th><th align="center" class="Rrule">%</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">Skin atrophy (n=1) and telangiectasia (n=2) were reported with Halobetasol Propionate Topical Foam, but not with vehicle foam.</td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">  Application site burning/stinging</td><td align="center" class="Rrule">12%</td><td align="center" class="Rrule">15%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Application site pain</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">&lt;1%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  Headache</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">&lt;1%</td> </tr> </tbody> </table></div>

Because the 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 local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.

Risk Summary

There are no available data on Halobetasol Propionate Topical Foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of Halobetasol Propionate Topical Foam [see Clinical Pharmacology (12.3)].

The background risk of major birth defects and miscarriage for the indicated population are unknown. 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

Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. Halobetasol propionate was embryotoxic in rabbits, but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

Risk Summary

There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Halobetasol Propionate Topical Foam and any potential adverse effects on the breastfed infant from Halobetasol Propionate Topical Foam or from the underlying maternal condition.

Clinical Considerations

Advise breastfeeding women not to apply Halobetasol Propionate Topical Foam directly to the nipple and/or areola to avoid direct infant exposure.

Safety and effectiveness of Halobetasol Propionate Topical Toam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.

The safety and effectiveness of Halobetasol Propionate Topical Foam for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. Subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with Halobetasol Propionate Topical Foam. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 23 subjects. After 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 µg/dL) that recovered upon retesting after at least 4 weeks of stopping the treatment [see Clinical Pharmacology (12.2)].

Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions (5.1)].

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see Warnings and Precautions (5.1)].

Clinical studies with Halobetasol Propionate Topical Foam included 131 patients aged 65 years and over. No overall differences in safety or effectiveness were observed between these patients and those younger than 65 years.

Topically applied Halobetasol Propionate Topical Foam can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Topically applied Halobetasol Propionate Topical Foam can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]." }

Halobetasol Propionate Topical Foam is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It has the following structural formula:

{ "type": "p", "children": [], "text": "Halobetasol Propionate Topical Foam is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It has the following structural formula:" }

It is practically insoluble in water and freely soluble in dichloromethane and in acetone. Each gram of Halobetasol Propionate Topical Foam contains 0.5 mg of halobetasol propionate in a white to off-white foam base consisting of alcohol (dehydrated), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol and purified water. Halobetasol Propionate Topical Foam is dispensed from an aluminum can pressurized with a hydrocarbon (isobutane and propane) propellant.

{ "type": "p", "children": [], "text": "It is practically insoluble in water and freely soluble in dichloromethane and in acetone. Each gram of Halobetasol Propionate Topical Foam contains 0.5 mg of halobetasol propionate in a white to off-white foam base consisting of alcohol (dehydrated), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol and purified water. Halobetasol Propionate Topical Foam is dispensed from an aluminum can pressurized with a hydrocarbon (isobutane and propane) propellant." }

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

Vasoconstrictor Assay

A vasoconstrictor assay in healthy patients with Halobetasol Propionate Topical Foam, 0.05% indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-pituitary-adrenal (HPA) axis suppression

The potential for hypothalamic-pituitary-adrenal (HPA) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH). In the first study, Halobetasol Propionate Topical Foam was applied to 25 adult subjects with moderate to severe plaque psoriasis involving a mean body surface area of 18.4%. A mean dose of 3.7 g of Halobetasol Propionate Topical Foam was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in 6 of 25 (24%) subjects. All subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment.

In the second study, Halobetasol Propionate Topical Foam was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with a mean percent BSA of 15.1% (range of 11% to 23%). The mean dose of Halobetasol Propionate Topical Foam used was 3.1 grams, which was applied twice daily for two weeks. In the study, 24 subjects completed the study, and 23 subjects had evaluable ACTH stimulation tests. HPA axis suppression was observed in 6 of the 23 subjects (26.1%), and all subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

In the HPA-axis and pharmacokinetic study, as described above in Clinical Pharmacology (12.2), pharmacokinetics was evaluated in a subgroup of 23 adult subjects with moderate to severe plaque psoriasis following twice daily treatment for 14 days. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects and steady state was achieved by Day 14. The mean (± standard deviation) Cmax concentration for HBP on Day 14 was 199.7 ± 217.3 pg/mL, with the corresponding median Tmax value of 1 hour (range 0 – 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1434.9 ± 1310.6 pg∙h/mL.

In the HPA axis study in subjects 12 to less than 18 years [see Clinical Pharmacology (12.2)], trough plasma concentrations of HBP were measured on Day 8 and Day 15 in 23 subjects following twice daily treatment for 14 days. On Day 8, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate in plasma that were above the quantifiable limit (≥20.0 pg/mL); mean halobetasol concentration was 154.6 ± 308.67 pg/mL. Similarly, on Day 15, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate above the quantifiable limit; mean halobetasol concentration was 59.9 ± 90.15 pg/mL. Of the 9 subjects with quantifiable plasma concentrations at Day 15, seven (7) also had quantifiable plasma concentrations at Day 8.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Halobetasol Propionate Topical Foam at dose concentrations from 0.005% to 0.05% or from 0.011 to 0.11 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro.

Studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

Halobetasol Propionate Topical Foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled studies (Study 1 [NCT02368210] and Study 2 [NCT02742441]).

{ "type": "p", "children": [], "text": "Halobetasol Propionate Topical Foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled studies (Study 1 [NCT02368210] and Study 2 [NCT02742441])." }

These studies were conducted in 560 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level Investigator's Global Assessment (IGA) scale, on which a subject scored either moderate or severe. Overall, approximately 60% of subjects were male and approximately 90% were Caucasian.

{ "type": "p", "children": [], "text": "These studies were conducted in 560 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level Investigator's Global Assessment (IGA) scale, on which a subject scored either moderate or severe. Overall, approximately 60% of subjects were male and approximately 90% were Caucasian." }

Subjects applied Halobetasol Propionate Topical Foam or vehicle to all affected areas twice daily for up to 14 consecutive days.

{ "type": "p", "children": [], "text": "Subjects applied Halobetasol Propionate Topical Foam or vehicle to all affected areas twice daily for up to 14 consecutive days." }

The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two-grade improvement from baseline at Week 2 (end of treatment) based on the IGA. The studies also evaluated treatment success for the individual signs of psoriasis (plaque elevation, scaling, and erythema) at the end of treatment. Table 2 presents these results.

{ "type": "p", "children": [], "text": "The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two-grade improvement from baseline at Week 2 (end of treatment) based on the IGA. The studies also evaluated treatment success for the individual signs of psoriasis (plaque elevation, scaling, and erythema) at the end of treatment. Table 2 presents these results." }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 2: Efficacy Results at Week 2 in Subjects with Plaque Psoriasis</span> </caption> <col align="left" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule" rowspan="2"></th><th align="center" class="Botrule Rrule" colspan="2">Study 1</th><th align="center" class="Botrule Rrule" colspan="2">Study 2</th> </tr> <tr class="Last"> <th align="center" class="Rrule">Halobetasol Propionate Topical Foam<br/>N=75</th><th align="center" class="Rrule">Vehicle Foam<br/>N=76</th><th align="center" class="Rrule">Halobetasol Propionate Topical Foam<br/>N=205</th><th align="center" class="Rrule">Vehicle Foam<br/>N=204</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Subjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two-grade improvement from baseline based on the IGA.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>Subjects who were cleared or almost cleared of the designated clinical sign with at least a two-grade improvement from baseline. Individual signs were rated by severity using a five-point scale ranging from 0 (clear) to 4 (severe). Subjects with baseline value of 0 or 1 were excluded.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Overall Treatment Success<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="center" class="Rrule">19 (25%)</td><td align="center" class="Rrule">3 (4%)</td><td align="center" class="Rrule">63 (31%)</td><td align="center" class="Rrule">15 (7%)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Plaque Elevation<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a></td><td align="center" class="Rrule">20/75 (27%)</td><td align="center" class="Rrule">3/76 (4%)</td><td align="center" class="Rrule">71/202 (35%)</td><td align="center" class="Rrule">20/203 (10%)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Scaling<a class="Sup" href="#footnote-2">†</a></td><td align="center" class="Rrule">21/75 (28%)</td><td align="center" class="Rrule">4/76 (5%)</td><td align="center" class="Rrule">68/201 (34%)</td><td align="center" class="Rrule">20/204 (10%)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Erythema<a class="Sup" href="#footnote-2">†</a></td><td align="center" class="Rrule">16/75 (21%)</td><td align="center" class="Rrule">2/76 (3%)</td><td align="center" class="Rrule">59/205 (29%)</td><td align="center" class="Rrule">17/204 (8%)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 2: Efficacy Results at Week 2 in Subjects with Plaque Psoriasis</span>\n</caption>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<thead>\n<tr class=\"First\">\n<th align=\"left\" class=\"Lrule Rrule\" rowspan=\"2\"></th><th align=\"center\" class=\"Botrule Rrule\" colspan=\"2\">Study 1</th><th align=\"center\" class=\"Botrule Rrule\" colspan=\"2\">Study 2</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"center\" class=\"Rrule\">Halobetasol Propionate Topical Foam<br/>N=75</th><th align=\"center\" class=\"Rrule\">Vehicle Foam<br/>N=76</th><th align=\"center\" class=\"Rrule\">Halobetasol Propionate Topical Foam<br/>N=205</th><th align=\"center\" class=\"Rrule\">Vehicle Foam<br/>N=204</th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"5\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-1\" name=\"footnote-1\">*</a>\n</dt>\n<dd>Subjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two-grade improvement from baseline based on the IGA.</dd>\n<dt>\n<a href=\"#footnote-reference-2\" name=\"footnote-2\">†</a>\n</dt>\n<dd>Subjects who were cleared or almost cleared of the designated clinical sign with at least a two-grade improvement from baseline. Individual signs were rated by severity using a five-point scale ranging from 0 (clear) to 4 (severe). Subjects with baseline value of 0 or 1 were excluded.</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">Overall Treatment Success<a class=\"Sup\" href=\"#footnote-1\" name=\"footnote-reference-1\">*</a></td><td align=\"center\" class=\"Rrule\">19 (25%)</td><td align=\"center\" class=\"Rrule\">3 (4%)</td><td align=\"center\" class=\"Rrule\">63 (31%)</td><td align=\"center\" class=\"Rrule\">15 (7%)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Plaque Elevation<a class=\"Sup\" href=\"#footnote-2\" name=\"footnote-reference-2\">†</a></td><td align=\"center\" class=\"Rrule\">20/75 (27%)</td><td align=\"center\" class=\"Rrule\">3/76 (4%)</td><td align=\"center\" class=\"Rrule\">71/202 (35%)</td><td align=\"center\" class=\"Rrule\">20/203 (10%)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Scaling<a class=\"Sup\" href=\"#footnote-2\">†</a></td><td align=\"center\" class=\"Rrule\">21/75 (28%)</td><td align=\"center\" class=\"Rrule\">4/76 (5%)</td><td align=\"center\" class=\"Rrule\">68/201 (34%)</td><td align=\"center\" class=\"Rrule\">20/204 (10%)</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Erythema<a class=\"Sup\" href=\"#footnote-2\">†</a></td><td align=\"center\" class=\"Rrule\">16/75 (21%)</td><td align=\"center\" class=\"Rrule\">2/76 (3%)</td><td align=\"center\" class=\"Rrule\">59/205 (29%)</td><td align=\"center\" class=\"Rrule\">17/204 (8%)</td>\n</tr>\n</tbody>\n</table></div>" }

Halobetasol Propionate Topical Foam, 0.05% is a white to off-white foam.

It is supplied in aluminum cans of:

50 grams (NDC 68308-769-50)

Store at 20°-25°C (68°-77°F); excursions permitted to 15°C and 30°C (59°F to 86°F). Contents under pressure.

Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze.

Halobetasol Propionate Topical Foam is flammable; avoid heat, flame, or smoking when using this product.

Important Administration Instructions:

Rx Only

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

Distributed by: Mayne Pharma Raleigh, NC 27609

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

Rev 05/2023

{ "type": "p", "children": [], "text": "Rev 05/2023" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="100%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">PATIENT INFORMATION<br/>Halobetasol Propionate (hal-oh-BAY-ta-sol PRO-pee-oh-nate)<br/> Topical Foam, 0.05%</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="1" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration</td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule"><span class="Bold">Important: Halobetasol Propionate Topical Foam is for use on the skin only.</span> Do not apply Halobetasol Propionate Topical Foam near or in your eyes, mouth, or vagina.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">What is Halobetasol Propionate Topical Foam?</span> <br/>Halobetasol Propionate Topical Foam is a prescription corticosteroid medicine used on the skin to treat plaque psoriasis in people 12 years of age and older. It is not known if Halobetasol Propionate Topical Foam is safe and effective in children under 12 years of age.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Before using Halobetasol Propionate Topical Toam, tell your healthcare provider about all of your medical conditions, including if you:</span> <ul class="Disc"> <li>have had irritation or other skin reaction to a steroid medicine in the past.</li> <li>have a skin infection. You may need medicine to treat the skin infection before using Halobetasol Propionate Topical Foam.</li> <li>have diabetes.</li> <li>have adrenal gland problems.</li> <li>have liver problems.</li> <li>plan to have surgery.</li> <li>are pregnant or plan to become pregnant. It is not known if Halobetasol Propionate Topical Foam will harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if halobetasol propionate passes into your breast milk. If you use Halobetasol Propionate Topical Foam and breastfeed, do not apply Halobetasol Propionate Topical Foam to your nipple or areola to avoid getting Halobetasol Propionate Topical Foam into your baby's mouth.</li> </ul> <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. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection, or use other products on your skin that contain corticosteroid.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">How should I use Halobetasol Propionate Topical Foam?</span> <ul class="Disc"> <li>Use Halobetasol Propionate Topical Foam exactly as your healthcare provider tells you to use it.</li> <li>Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin areas 2 times each day.</li> <li>You should not use more than 50 grams of Halobetasol Propionate Topical Foam in 1 week.</li> <li>Avoid using Halobetasol Propionate Topical Foam on your face, underarms (armpits), or groin areas.</li> <li>Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.</li> <li>Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Halobetasol Propionate Topical Foam.</li> <li>Do not use Halobetasol Propionate Topical Foam longer than 2 continuous weeks unless advised to do so by your prescriber.</li> <li>Wash your hands after using Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">What should I avoid while using Halobetasol Propionate Topical Foam?<br/> Halobetasol Propionate Topical Foam is flammable.</span> Avoid heat, flame, or smoking during and right after applying Halobetasol Propionate Topical Foam to your skin.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">What are the possible side effects of Halobetasol Propionate Topical Foam?</span> <br/>Halobetasol Propionate Topical Foam may cause serious side effects, including: <ul class="Disc"> <li> <span class="Bold">Halobetasol Propionate Topical Foam can pass through your skin.</span> Too much Halobetasol Propionate Topical Foam passing through your skin can cause adrenal glands to stop working.</li> <li> <span class="Bold">Cushing's syndrome,</span> a condition that happens when your body is exposed to too much of the hormone cortisol.</li> <li> <span class="Bold">High blood sugar</span> (hyperglycemia).</li> <li> <span class="Bold">Vision problems.</span> Halobetasol Propionate Topical Foam may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Halobetasol Propionate Topical Foam.</li> <li> <span class="Bold">Skin reactions at the treated skin site.</span> Tell your healthcare provider if you get any skin reactions or skin infections.</li> <li> <span class="Bold">Effects on growth and weight in children.</span> </li> </ul> Your healthcare provider may do certain blood tests to check for side effects.<br/> <span class="Bold">The most common side effect of Halobetasol Propionate Topical Foam</span> is mild to moderate pain at the treated site.<br/> These are not all of the possible side effects of Halobetasol Propionate Topical Foam.<br/> 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"><span class="Bold">How should I store Halobetasol Propionate Topical Foam?</span> <ul class="Disc"> <li>Store Halobetasol Propionate Topical Foam at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>Do not puncture or burn Halobetasol Propionate Topical Foam can.</li> <li>Do not store Halobetasol Propionate Topical Foam next to heat or store at temperatures above 120°F (49°C).</li> <li>Do not freeze Halobetasol Propionate Topical Foam.</li> </ul> Keep Halobetasol Propionate Topical Foam and all medicines out of the reach of children. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">General information about the safe and effective use of Halobetasol Propionate Topical Foam.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Halobetasol Propionate Topical Foam for a condition for which it was not prescribed. Do not give Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam that is written for health professionals.</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule"><span class="Bold">What are the ingredients in halobetasol propionate topical foam?</span> <br/> <span class="Bold">Active ingredient:</span> halobetasol propionate<br/> <span class="Bold">Inactive ingredients:</span> alcohol (dehydrated), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water. Halobetasol Propionate Topical Foam is dispensed from an aluminum can pressurized with a hydrocarbon propellant containing isobutane and propane.<br/> Distributed by:<br/> <span class="Bold">Mayne Pharma</span> <br/>Raleigh, NC 27609<br/>For more information, call 1-866-634-9120 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\">PATIENT INFORMATION<br/>Halobetasol Propionate (hal-oh-BAY-ta-sol PRO-pee-oh-nate)<br/> Topical Foam, 0.05%</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"1\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Important: Halobetasol Propionate Topical Foam is for use on the skin only.</span> Do not apply Halobetasol Propionate Topical Foam near or in your eyes, mouth, or vagina.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What is Halobetasol Propionate Topical Foam?</span>\n<br/>Halobetasol Propionate Topical Foam is a prescription corticosteroid medicine used on the skin to treat plaque psoriasis in people 12 years of age and older. It is not known if Halobetasol Propionate Topical Foam is safe and effective in children under 12 years of age.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Before using Halobetasol Propionate Topical Toam, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul class=\"Disc\">\n<li>have had irritation or other skin reaction to a steroid medicine in the past.</li>\n<li>have a skin infection. You may need medicine to treat the skin infection before using Halobetasol Propionate Topical Foam.</li>\n<li>have diabetes.</li>\n<li>have adrenal gland problems.</li>\n<li>have liver problems.</li>\n<li>plan to have surgery.</li>\n<li>are pregnant or plan to become pregnant. It is not known if Halobetasol Propionate Topical Foam will harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if halobetasol propionate passes into your breast milk. If you use Halobetasol Propionate Topical Foam and breastfeed, do not apply Halobetasol Propionate Topical Foam to your nipple or areola to avoid getting Halobetasol Propionate Topical Foam into your baby's mouth.</li>\n</ul>\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. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection, or use other products on your skin that contain corticosteroid.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">How should I use Halobetasol Propionate Topical Foam?</span>\n<ul class=\"Disc\">\n<li>Use Halobetasol Propionate Topical Foam exactly as your healthcare provider tells you to use it.</li>\n<li>Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin areas 2 times each day.</li>\n<li>You should not use more than 50 grams of Halobetasol Propionate Topical Foam in 1 week.</li>\n<li>Avoid using Halobetasol Propionate Topical Foam on your face, underarms (armpits), or groin areas.</li>\n<li>Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.</li>\n<li>Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Halobetasol Propionate Topical Foam.</li>\n<li>Do not use Halobetasol Propionate Topical Foam longer than 2 continuous weeks unless advised to do so by your prescriber.</li>\n<li>Wash your hands after using Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What should I avoid while using Halobetasol Propionate Topical Foam?<br/>\t\t\t\t\t\t\t\t\t\tHalobetasol Propionate Topical Foam is flammable.</span> Avoid heat, flame, or smoking during and right after applying Halobetasol Propionate Topical Foam to your skin.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What are the possible side effects of Halobetasol Propionate Topical Foam?</span>\n<br/>Halobetasol Propionate Topical Foam may cause serious side effects, including: \t\t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Halobetasol Propionate Topical Foam can pass through your skin.</span> Too much Halobetasol Propionate Topical Foam passing through your skin can cause adrenal glands to stop working.</li>\n<li>\n<span class=\"Bold\">Cushing's syndrome,</span> a condition that happens when your body is exposed to too much of the hormone cortisol.</li>\n<li>\n<span class=\"Bold\">High blood sugar</span> (hyperglycemia).</li>\n<li>\n<span class=\"Bold\">Vision problems.</span> Halobetasol Propionate Topical Foam may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Halobetasol Propionate Topical Foam.</li>\n<li>\n<span class=\"Bold\">Skin reactions at the treated skin site.</span> Tell your healthcare provider if you get any skin reactions or skin infections.</li>\n<li>\n<span class=\"Bold\">Effects on growth and weight in children.</span>\n</li>\n</ul>\t\t\t\t\t\t\t\t\t\tYour healthcare provider may do certain blood tests to check for side effects.<br/>\n<span class=\"Bold\">The most common side effect of Halobetasol Propionate Topical Foam</span> is mild to moderate pain at the treated site.<br/>\t\t\t\t\t\t\t\t\t\tThese are not all of the possible side effects of Halobetasol Propionate Topical Foam.<br/>\t\t\t\t\t\t\t\t\t\tCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA­-1088.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">How should I store Halobetasol Propionate Topical Foam?</span>\n<ul class=\"Disc\">\n<li>Store Halobetasol Propionate Topical Foam at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>Do not puncture or burn Halobetasol Propionate Topical Foam can.</li>\n<li>Do not store Halobetasol Propionate Topical Foam next to heat or store at temperatures above 120°F (49°C).</li>\n<li>Do not freeze Halobetasol Propionate Topical Foam.</li>\n</ul>\t\t\t\t\t\t\t\t\t\tKeep Halobetasol Propionate Topical Foam and all medicines out of the reach of children. \t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">General information about the safe and effective use of Halobetasol Propionate Topical Foam.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Halobetasol Propionate Topical Foam for a condition for which it was not prescribed. Do not give Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam that is written for health professionals.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What are the ingredients in halobetasol propionate topical foam?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> halobetasol propionate<br/>\n<span class=\"Bold\">Inactive ingredients:</span> alcohol (dehydrated), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water. Halobetasol Propionate Topical Foam is dispensed from an aluminum can pressurized with a hydrocarbon propellant containing isobutane and propane.<br/>\t\t\t\t\t\t\t\t\t\tDistributed by:<br/>\n<span class=\"Bold\">Mayne Pharma</span>\n<br/>Raleigh, NC 27609<br/>For more information, call 1-866-634-9120 \t\t\t\t\t\t\t\t\t</td>\n</tr>\n</tbody>\n</table></div>" }

Revised: 05/2023

{ "type": "p", "children": [], "text": "Revised: 05/2023" }

INSTRUCTIONS FOR USEHalobetasol Propionate (hal-oh-BAY-ta-sol PRO-pee-oh-nate) Topical Foam, 0.05%

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USEHalobetasol Propionate (hal-oh-BAY-ta-sol PRO-pee-oh-nate) Topical Foam, 0.05%\n" }

Read the Patient Information and Instructions for Use before you use Halobetasol Propionate Topical Foam.

{ "type": "p", "children": [], "text": "Read the Patient Information and Instructions for Use before you use Halobetasol Propionate Topical Foam." }

Important information: Halobetasol Propionate Topical Foam is for skin use only. Do not get Halobetasol Propionate Topical Foam in your mouth, eyes, or vagina.

{ "type": "p", "children": [], "text": "\nImportant information: Halobetasol Propionate Topical Foam is for skin use only. Do not get Halobetasol Propionate Topical Foam in your mouth, eyes, or vagina." }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="45%"/> <col align="left" valign="top" width="55%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">Parts of the Halobetasol Propionate Topical Foam can:</span></td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=halobetasol-02.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Step 1:</span> Before applying Halobetasol Propionate Topical Foam for the first time, remove cap and break the small tab at the base of the actuator by gently pushing the actuator away from the tab as shown. Do not break the hinge on the actuator.</td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=halobetasol-03.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Step 2:</span> Shake the can well before use.</td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=halobetasol-04.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Step 3:</span> Turn the can completely upside down.</td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=halobetasol-05.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Step 4:</span> Press down on the actuator to dispense a small amount of the foam into the palm of your hand.</td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=halobetasol-06.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Step 5:</span> Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin area. Gently rub Halobetasol Propionate Topical Foam into the affected skin until the foam disappears.<br/>Repeat Steps 4 and 5 to all the affected areas as prescribed by your healthcare provider.</td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=halobetasol-07.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6"/></p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">Step 6:</span> After applying Halobetasol Propionate Topical Foam, put the cap back on the can.</td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">Step 7:</span> Wash your hands after applying Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"45%\"/>\n<col align=\"left\" valign=\"top\" width=\"55%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">Parts of the Halobetasol Propionate Topical Foam can:</span></td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=halobetasol-02.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Step 1:</span> Before applying Halobetasol Propionate Topical Foam for the first time, remove cap and break the small tab at the base of the actuator by gently pushing the actuator away from the tab as shown. Do not break the hinge on the actuator.</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=halobetasol-03.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Step 2:</span> Shake the can well before use.</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=halobetasol-04.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Step 3:</span> Turn the can completely upside down.</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=halobetasol-05.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Step 4:</span> Press down on the actuator to dispense a small amount of the foam into the palm of your hand.</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=halobetasol-06.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Step 5:</span> Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin area. Gently rub Halobetasol Propionate Topical Foam into the affected skin until the foam disappears.<br/>Repeat Steps 4 and 5 to all the affected areas as prescribed by your healthcare provider.</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=halobetasol-07.jpg&amp;setid=24c41e6d-a314-4984-b45f-e5aa1fffa9b6\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">Step 6:</span> After applying Halobetasol Propionate Topical Foam, put the cap back on the can.</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">Step 7:</span> Wash your hands after applying Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.</td>\n</tr>\n</tbody>\n</table></div>" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Instructions for Use 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" }

Rev 05/2023

{ "type": "p", "children": [], "text": "Rev 05/2023" }

NDC 68308-769-50

{ "type": "p", "children": [], "text": "NDC 68308-769-50" }

HalobetasolPropionateTopical Foam, 0.05%

{ "type": "p", "children": [], "text": "HalobetasolPropionateTopical Foam, 0.05%" }

For topical use only.

{ "type": "p", "children": [], "text": "For topical use only." }

Not for ophthalmic, oral,or intravaginal use.

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

Keep Out of Reachof Children.

{ "type": "p", "children": [], "text": "Keep Out of Reachof Children." }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY" }

Net Wt. 50 g

{ "type": "p", "children": [], "text": "Net Wt. 50 g" }

mayne pharma

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