CLOBEX Lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use CLOBEX Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

CLOBEX Lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. CLOBEX Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

CLOBEX Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.                     CLOBEX Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. CLOBEX Lotion, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and up to 2 additional weeks in localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX Lotion, 0.05%. Unless directed by physician, CLOBEX Lotion, 0.05% should not be used with occlusive dressings.

{ "type": "p", "children": [], "text": "CLOBEX Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.                     CLOBEX Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely.\nThe total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. \nCLOBEX Lotion, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and up to 2 additional weeks in localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX Lotion, 0.05%. \nUnless directed by physician, CLOBEX Lotion, 0.05% should not be used with occlusive dressings." }

Lotion, 0.05% w/w. Each gram of CLOBEX Lotion, 0.05%, contains 0.5 mg of clobestasol propionate in a white liquid.

{ "type": "p", "children": [], "text": "Lotion, 0.05% w/w. Each gram of CLOBEX Lotion, 0.05%, contains 0.5 mg of clobestasol propionate in a white liquid." }

None

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

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for clinical glucocorticosteroid insufficiency after withdrawal of treatment.  This may occur during treatment of upon withdrawal of the topical corticosteroid.

The effect of CLOBEX Lotion, 0.05% on HPA axis function was compared to clobetasol propionate cream 0.05% (Temovate E® Emollient, 0.05%) in adults in two trials, one for psoriasis and one for atopic dermatitis. In total, 8 of 10 evaluable subjects with moderate to severe plaque psoriasis experienced adrenal suppression following 4 weeks of CLOBEX Lotion, 0.05% therapy (treatment beyond 4 consecutive weeks is not recommended in moderate to severe plaque psoriasis.) In follow-up testing, 1 of 2 subjects remained suppressed after 8 days. In this comparative trial, for clobetasol propionate cream, 0.05% there were 3 of 10 evaluable subjects with HPA axis suppression.

Furthermore, 5 of 9 evaluable subjects with moderate to severe atopic dermatitis experienced adrenal suppression following 2 weeks of CLOBEX Lotion, 0.05% therapy (treatment beyond 2 consecutive weeks is not recommended in moderate to severe atopic dermatitis). Of the 3 subjects that had follow-up testing, one subject failed to recover adrenal function 7 days post-treatment. For subjects treated with clobetasol propionate cream, 0.05%, 4 of 9 evaluable subjects experienced adrenal suppression following 2 weeks of treatment. Of the 2 subjects that had follow-up testing, both recovered adrenal function 7 days post-treatment. The proportion of subjects suppressed may be underestimated because the adrenal glands were stimulated weekly with cosyntropin in these trials.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to 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.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Use in Specific Populations (8.4)].

Local adverse reactions may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria, skin atrophy and telangiectasia. Some local adverse reactions may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX Lotion, 0.05%, should be discontinued until the infection has been adequately controlled.

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 controlled, clinical trials with CLOBEX Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia. The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with CLOBEX Lotion, 0.05% at 1% or greater was:

<div class="scrollingtable"><table border="1" cellpadding="4" cellspacing="0"> <caption> <span>Table 1: Adverse Reactions with Incidence ≥ 1% in Clinical Trials</span> </caption> <colgroup> <col width="250"/> <col width="250"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Incidence</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Skin Atrophy</td><td align="center" class="Botrule Lrule Rrule Toprule">4.2%</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Telangiectasia</td><td align="center" class="Botrule Lrule Rrule Toprule">3.2%</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Discomfort Skin</td><td align="center" class="Botrule Lrule Rrule Toprule">1.3%</td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule">Skin Dry</td><td align="center" class="Botrule Lrule Rrule Toprule">1.0%</td> </tr> </tbody> </table></div>

Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

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 post-approval use of CLOBEX Lotion, 0.05%.

Teratogenic Effects: Pregnancy Category C:                            There are no adequate and well-controlled studies in pregnant women. Therefore, CLOBEX Lotion, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 μg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no-observed-effect level (NOEL) for clobetasol propionate was less than 12.5 μg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 μg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

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 breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX Lotion, 0.05% is administered to a nursing woman.

Use of CLOBEX Lotion, 0.05% in pediatric patients is not recommended due to the potential for HPA axis suppression [see Warnings and Precautions (5.1)].                           The HPA axis suppression potential of CLOBEX Lotion, 0.05% has been studied in adolescents (12 to 17 years of age) with moderate to severe atopic dermatitis covering a minimum of 20% of the total body surface area. In total 14 subjects were evaluated for HPA axis function. Subjects were treated twice daily for 2 weeks with CLOBEX Lotion, 0.05%. After 2 weeks of treatment, 9 out of 14 of the subjects experienced adrenal suppression. One out of 4 subjects treated with CLOBEX Lotion, 0.05% who were retested remained suppressed two weeks post-treatment. In comparison, 2 of 10 subjects treated with clobetasol propionate cream, 0.05% demonstrated HPA axis suppression. One subject who was retested recovered. None of the subjects who developed HPA axis suppression had concomitant clinical signs of adrenal suppression and none of them was discontinued from the study for reasons related to the safety or tolerability of CLOBEX Lotion, 0.05%. However patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Because of higher ratio of skin surface area to body mass, 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 glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Clinical studies of CLOBEX Lotion, 0.05% did not include sufficient numbers of subjects aged 65 and over to adequately determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Topically applied CLOBEX Lotion, 0.05% can be absorbed in sufficient amount to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Topically applied CLOBEX Lotion, 0.05% can be absorbed in sufficient amount to produce systemic effects [see Warnings and Precautions (5.1)]." }

CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7).                     The following is the chemical structure:

{ "type": "p", "children": [], "text": "CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7).                     The following is the chemical structure:" }

Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.

{ "type": "p", "children": [], "text": "\n\nClobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water." }

Like other topical corticosteroids CLOBEX Lotion, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Vasoconstrictor Assay CLOBEX Lotion, 0.05% is in the super-high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, CLOBEX Lotion, 0.05% demonstrated rates of suppression that were numerically higher than those of a clobetasol propionate 0.05% cream (Temovate E® Emollient, 0.05%), [see Warnings and Precautions (5.1) and Use in Specific Population (8.4)].

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.                            Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption. There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis).                            Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks. Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test. The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 µg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 µg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

The efficacy of CLOBEX Lotion, 0.05% in psoriasis and atopic dermatitis has been demonstrated in two adequate and well-controlled clinical trials. The first trial was conducted in subjects with moderate to severe plaque psoriasis. Subjects were treated twice daily for 4 weeks with either CLOBEX Lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of CLOBEX Lotion, 0.05% in treating moderate to severe plaque psoriasis was superior to that of vehicle.                     At the end of treatment (4 weeks), 30 of 82 subjects (36.6%) treated with CLOBEX Lotion, 0.05% compared with 0 of 29 (0%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, plaque elevation, or scaling) on the Global Severity scale of psoriasis. The second trial was conducted in subjects with moderate to severe atopic dermatitis. Subjects were treated twice daily for 2 weeks with either CLOBEX Lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of CLOBEX Lotion, 0.05% in treating moderate to severe atopic dermatitis was superior to that of vehicle. At the end of treatment (2 weeks), 41 of 96 subjects (42.7%) treated with CLOBEX Lotion, 0.05% compared with 4 of 33 (12.1%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, induration/papulation, oozing/crusting, or pruritus) on the Global Severity scale of atopic dermatitis.

{ "type": "p", "children": [], "text": "The efficacy of CLOBEX Lotion, 0.05% in psoriasis and atopic dermatitis has been demonstrated in two adequate and well-controlled clinical trials. The first trial was conducted in subjects with moderate to severe plaque psoriasis. Subjects were treated twice daily for 4 weeks with either CLOBEX Lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of CLOBEX Lotion, 0.05% in treating moderate to severe plaque psoriasis was superior to that of vehicle.                     At the end of treatment (4 weeks), 30 of 82 subjects (36.6%) treated with CLOBEX Lotion, 0.05% compared with 0 of 29 (0%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, plaque elevation, or scaling) on the Global Severity scale of psoriasis.\nThe second trial was conducted in subjects with moderate to severe atopic dermatitis. Subjects were treated twice daily for 2 weeks with either CLOBEX Lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of CLOBEX Lotion, 0.05% in treating moderate to severe atopic dermatitis was superior to that of vehicle.\nAt the end of treatment (2 weeks), 41 of 96 subjects (42.7%) treated with CLOBEX Lotion, 0.05% compared with 4 of 33 (12.1%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, induration/papulation, oozing/crusting, or pruritus) on the Global Severity scale of atopic dermatitis.\n" }

CLOBEX Lotion, 0.05% is a white liquid, supplied in the following sizes:

{ "type": "p", "children": [], "text": "CLOBEX Lotion, 0.05% is a white liquid, supplied in the following sizes: " }

2 fl oz/59 mL NDC 0299-3848-02 high density polyethylene bottles

{ "type": "p", "children": [], "text": "2 fl oz/59 mL NDC 0299-3848-02 high density polyethylene bottles" }

4 fl oz/118 mL NDC 0299-3848-04 high density polyethylene bottles

{ "type": "p", "children": [], "text": "4 fl oz/118 mL NDC 0299-3848-04 high density polyethylene bottles" }

Store at USP controlled room temperature 68° to 77°F (20°-25°C), with excursions permitted between 59° and 86°F (15° - 30°C). Protect from freezing.

{ "type": "p", "children": [], "text": "Store at USP controlled room temperature 68° to 77°F (20°-25°C), with excursions permitted between 59° and 86°F (15° - 30°C). Protect from freezing." }

See FDA-approved patient labeling (Patient Information)

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

Information for Patients

{ "type": "p", "children": [], "text": "\nInformation for Patients\n" }

Inform the patient using toical corticosteroids to adhere to the following instructions:

{ "type": "p", "children": [], "text": "Inform the patient using toical corticosteroids to adhere to the following instructions:\n" }

{ "type": "ul", "children": [ "This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.", "This medication should not be used for any disorder other than that for which it was prescribed.", "Do not use other corticosteroid-containing products while using CLOBEX (clobetasol propionate) Lotion, 0.05%.", "The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.", "Patients should wash their hands after applying the medication.", "Patients should report any signs of local or systemic adverse reactions to the physician.", "Patients should inform their physicians that they are using CLOBEX (clobetasol propionate) Lotion, 0.05% if surgery is contemplated.", "This medication is for external use only. It should not be used on the face, underarms, or groin area, and avoid contact with the eyes and lips.", "As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.", "Patients should be informed to not use more than 50 g (50 mL or 1.75 fl. oz.) per week of CLOBEX Lotion, 0.05%." ], "text": "" }

Patient Information CLOBEX® (KLO-bex) (clobetasol propionate) Lotion

{ "type": "p", "children": [], "text": "\nPatient Information\n\nCLOBEX® (KLO-bex)\n\n(clobetasol propionate)\n\nLotion\n" }

Important: For use on skin only. Do not get CLOBEX Lotion near or in your eyes, mouth or vagina. Read the Patient Information that comes with CLOBEX Lotion before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is CLOBEX Lotion? CLOBEX Lotion is a prescription corticosteroid medicine used to reduce the swelling (inflammation) and itching caused by certain skin conditions called corticosteroid-responsive dermatoses, including atopic dermatitis and psoriasis, in people 18 years of age and older. CLOBEX Lotion is for use on the skin only (topical).

{ "type": "p", "children": [], "text": "\n\nImportant: For use on skin only. Do not get CLOBEX Lotion near or in your eyes, mouth or vagina.\nRead the Patient Information that comes with CLOBEX Lotion before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. \n\nWhat is CLOBEX Lotion?\nCLOBEX Lotion is a prescription corticosteroid medicine used to reduce the swelling (inflammation) and itching caused by certain skin conditions called corticosteroid-responsive dermatoses, including atopic dermatitis and psoriasis, in people 18 years of age and older. CLOBEX Lotion is for use on the skin only (topical)." }

{ "type": "ul", "children": [ "CLOBEX Lotion should only be used for the shortest amount of time needed to treat your skin condition.", "CLOBEX Lotion should not be used for more than 2 weeks in a row unless your doctor tells you to use it for a longer time.", "You should not apply more than 50 mL (1.75 fluid ounces) of CLOBEX Lotion to your skin in 1 week." ], "text": "" }

You should not use CLOBEX Lotion:

{ "type": "p", "children": [], "text": "\n\nYou should not use CLOBEX Lotion:\n" }

{ "type": "ul", "children": [ "on your face, underarms (armpits), or groin areas", "if you have thinning of the skin (atrophy) at the treatment site", "to treat rosacea or a rash around your mouth (perioral dermatitis)" ], "text": "" }

CLOBEX Lotion should not be used in children under 18 years of age. What should I tell my doctor before using CLOBEX Lotion? Before you use CLOBEX Lotion, tell your doctor if you:

{ "type": "p", "children": [], "text": "\nCLOBEX Lotion should not be used in children under 18 years of age.\n\nWhat should I tell my doctor before using CLOBEX Lotion?\n\n\nBefore you use CLOBEX Lotion, tell your doctor if you:\n" }

{ "type": "ul", "children": [ "have a skin infection. You may need medicine to treat the skin infection before you use CLOBEX Lotion.", "have any open sores or cuts on your skin", "plan to have surgery", "have any other medical conditions", "are pregnant or plan to become pregnant. It is not known if CLOBEX Lotion can harm your unborn baby.", "are breast-feeding or plan to breast-feed. It is not known if CLOBEX Lotion passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use CLOBEX Lotion." ], "text": "" }

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using CLOBEX Lotion. Ask your doctor or pharmacist if you are not sure. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use CLOBEX Lotion?

{ "type": "p", "children": [], "text": "\n\nTell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using CLOBEX Lotion. Ask your doctor or pharmacist if you are not sure.\nKnow the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.\n\nHow should I use CLOBEX Lotion?\n" }

{ "type": "ul", "children": [ "Use CLOBEX Lotion exactly as your doctor tells you to use it.", "Your doctor should tell you how much CLOBEX Lotion to use and where to apply it.", "CLOBEX Lotion is for skin use only (topical).", "You should not use CLOBEX Lotion on your face, underarms or groin. Avoid getting CLOBEX Lotion in your eyes or on your lips.", "Apply CLOBEX Lotion 2 times each day.", "Apply only enough CLOBEX Lotion to cover your affected skin areas." ], "text": "" }

To apply CLOBEX Lotion:

{ "type": "p", "children": [], "text": "\n\nTo apply CLOBEX Lotion:\n" }

{ "type": "ul", "children": [ "Turn the bottle of CLOBEX Lotion upside down.", "Apply CLOBEX Lotion onto your fingertips or directly on your affected skin area.", "Rub CLOBEX Lotion into your affected skin area gently and completely.", "Repeat these steps to apply CLOBEX Lotion to all affected skin areas as your doctor tells you.", "Wash your hands after applying CLOBEX Lotion.", "Do not bandage, cover or wrap your treated areas unless your doctor tells you to.", "Tell your doctor if your skin condition is not getting better after using CLOBEX Lotion for 2 weeks in a row. Do not use CLOBEX Lotion for more than 2 weeks unless your doctor tells you to." ], "text": "" }

What are the possible side effects of CLOBEX Lotion? CLOBEX Lotion can pass through your skin. Too much CLOBEX Lotion passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working. The most common side effects of CLOBEX Lotion include:

{ "type": "p", "children": [], "text": "\n\nWhat are the possible side effects of CLOBEX Lotion?\n\nCLOBEX Lotion can pass through your skin. Too much CLOBEX Lotion passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.\n\nThe most common side effects of CLOBEX Lotion include:\n" }

{ "type": "ul", "children": [ "burning, stinging, itching, redness, irritation and dry skin", "thinning of the skin", "widening of small blood vessels in the skin", "skin discomfort at the site of application" ], "text": "" }

If you go to another doctor for illness, injury or surgery tell your doctor that you are using CLOBEX Lotion. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CLOBEX Lotion. 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. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137. How should I store CLOBEX Lotion?

{ "type": "p", "children": [], "text": "\nIf you go to another doctor for illness, injury or surgery tell your doctor that you are using CLOBEX Lotion.\nTell your doctor if you have any side effect that bothers you or that does not go away.\nThese are not all the possible side effects of CLOBEX Lotion. For more information, ask your doctor or pharmacist. \nCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\nYou may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.\n\nHow should I store CLOBEX Lotion?\n" }

{ "type": "ul", "children": [ "Store CLOBEX Lotion at room temperature between 68°F to 77°F (20°C to 25°C).", "Do not freeze CLOBEX Lotion." ], "text": "" }

Keep CLOBEX Lotion and all medicines out of reach of children. General information about CLOBEX Lotion. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CLOBEX Lotion for a condition for which it was not prescribed. Do not give CLOBEX Lotion 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 CLOBEX Lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX Lotion that is written for health professionals. What are the ingredients in CLOBEX Lotion? Active ingredient: clobetasol propionate Inactive ingredients: hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water. This Patient Information has been approved by the U.S. Food and Drug Administration. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAMade in CanadaP53324-0Revised 03/2017

{ "type": "p", "children": [], "text": "\n\n\nKeep CLOBEX Lotion and all medicines out of reach of children.\n\n\nGeneral information about CLOBEX Lotion.\nMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CLOBEX Lotion for a condition for which it was not prescribed. Do not give CLOBEX Lotion to other people, even if they have the same symptoms that you have. It may harm them. \nThis Patient Information leaflet summarizes the most important information about CLOBEX Lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX Lotion that is written for health professionals.\n\nWhat are the ingredients in CLOBEX Lotion?\nActive ingredient: clobetasol propionate Inactive ingredients: hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.\nThis Patient Information has been approved by the U.S. Food and Drug Administration.\n\nMarketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAMade in CanadaP53324-0Revised 03/2017\n\n" }

Rx Only NDC 0299-3848-04 CLOBEX® (clobetasol propionate) LOTION 0.05% 4 FL OZ (118 mL) For external use only.Not for eye use. Galderma

{ "type": "p", "children": [], "text": "\nRx Only\nNDC 0299-3848-04\n\n\n\nCLOBEX® (clobetasol propionate) LOTION 0.05%\n4 FL OZ (118 mL)\n\nFor external use only.Not for eye use.\n\nGalderma\n\n" }

BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

{ "type": "p", "children": [], "text": "BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery." }

Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.

Wash hands well before each use.

If using other eye drops in addition to BYQLOVI, wait at least 5 minutes between instillation of BYQLOVI and other eye drops.

Ophthalmic suspension containing clobetasol propionate 0.05% (0.5 mg/mL).

{ "type": "p", "children": [], "text": "Ophthalmic suspension containing clobetasol propionate 0.05% (0.5 mg/mL)." }

BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

{ "type": "p", "children": [], "text": "BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures." }

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If BYQLOVI is used for 10 days or longer, IOP should be monitored.

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining .

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal culture should be taken when appropriate.

Do not allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension.

BYQLOVI should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BYQLOVI. The preservative in BYQLOVI may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes following administration of BYQLOVI.

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.

Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). Many of these reactions may have been the consequence of the surgical procedure.

Risk Summary

There are no adequate and well-controlled clinical studies of BYQLOVI administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of BYQLOVI  [see Clinical Pharmacology (12.3)] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data) .

BYQLOVI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the US 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 embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg. Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption.

In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption.

Risk Summary

There is no information regarding the presence of clobetasol propionate in human milk, the effects on the breastfed infant, or the effects on milk production.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. However, systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3)], and it is not known whether measurable levels of clobetasol propionate would be present in maternal milk following topical ocular administration.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BYQLOVI, and any potential adverse effects on the breastfed infant from BYQLOVI.

The safety and effectiveness of BYQLOVI in pediatric patients have not been established.

No overall differences in safety and effectiveness of BYQLOVI have been observed between patients 65 years of age and older and younger adult patients.

BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

{ "type": "p", "children": [], "text": "BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity." }

Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate and it has the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate and it has the following structural formula:" }

Clobetasol propionate has the empirical formula C 25H 32CIFO 5and a molecular weight of 467.

{ "type": "p", "children": [], "text": "Clobetasol propionate has the empirical formula C\n \n 25H\n \n 32CIFO\n \n 5and a molecular weight of 467.\n\n " }

BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use.

{ "type": "p", "children": [], "text": "BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use." }

Each mL of BYQLOVI contains:

{ "type": "p", "children": [], "text": "Each mL of BYQLOVI contains:" }

ACTIVE: clobetasol propionate 0.5 mg (0.05%)

{ "type": "p", "children": [], "text": "ACTIVE: clobetasol propionate 0.5 mg (0.05%)" }

INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection

{ "type": "p", "children": [], "text": "INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection" }

PRESERVATIVE: benzalkonium chloride 0.0036%.

{ "type": "p", "children": [], "text": "PRESERVATIVE: benzalkonium chloride 0.0036%." }

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2.

In patients treated with BYQLOVI twice daily for 21 days, the mean (SD) changes from baseline in cortisol concentrations, -18.1 (126.2) nmol/L and +5.1 (129.8) nmol/L for the BYQLOVI and matching vehicle arms, respectively, were not statistically significant, considering the variability observed in the cortisol concentrations.

After the first and second (12 hours apart) ocular instillations of BYQLOVI in healthy adults (n=12), peak plasma clobetasol propionate concentrations (C max) were below the lower limit of quantitation (LLOQ, 0.04 ng/mL) in 13 out of 22 PK profiles and ranged from 0.040 to 0.182 ng/mL in the other 9 profiles. Time to peak concentration (T max) was observed between 0.5 - 1 hour post-dose. Clobetasol propionate concentrations declined to lower than LLOQ after 4 to 5 hours post-dose.

Carcinogenesis

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

Mutagenesis

Clobetasol propionate was not mutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Impairment of Fertility

Fertility studies in the rat following subcutaneous administration at dosage levels up to 50 µg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. This dose is approximately 10 times the recommended human ophthalmic dose of BYQLOVI (0.83 μg/kg/day), estimated based on body surface area and assuming 100% systemic absorption. Note that systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3)] .

Clinical efficacy was evaluated in 2 multi-center, randomized, double-masked, vehicle-controlled trials in which patients had ≥10 cells in the anterior chamber after cataract surgery were assigned to BYQLOVI 0.05% (N=366) or vehicle (N=382) ( NCT04739709(Study 1) and NCT04810962(Study 2)). One drop of Clobetasol Propionate Ophthalmic Suspension 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber cell count of 0 maintained through Day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through Day 15 without rescue medication) were assessed at post-operative day (POD) 4, 8, and 15. (Study 1) and NCT04810962(Study 2)). One drop of BYQLOVI 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber cell count of 0 maintained through Day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through Day 15 without rescue medication) were assessed at post-operative day (POD) 4, 8, and 15.

{ "type": "p", "children": [], "text": "Clinical efficacy was evaluated in 2 multi-center, randomized, double-masked, vehicle-controlled trials in which patients had ≥10 cells in the anterior chamber after cataract surgery were assigned to BYQLOVI 0.05% (N=366) or vehicle (N=382) (\n \n NCT04739709(Study 1) and\n \n NCT04810962(Study 2)). One drop of Clobetasol Propionate Ophthalmic Suspension 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber cell count of 0 maintained through Day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through Day 15 without rescue medication) were assessed at post-operative day (POD) 4, 8, and 15. (Study 1) and\n \n NCT04810962(Study 2)). One drop of BYQLOVI 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber cell count of 0 maintained through Day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through Day 15 without rescue medication) were assessed at post-operative day (POD) 4, 8, and 15.\n\n " }

The co-primary efficacy endpoints were the proportion of subjects with Anterior Chamber Cell (ACC) count = 0 (ACC grade = 0) at POD8 maintained through POD15, and the proportion of subjects with Ocular Pain Grade = 0 at POD4 maintained through POD15. In the intent-to-treat analysis, both co-primary efficacy endpoints were statistically significantly better in BYQLOVI 0.05%-treated patients compared to vehicle-treated patients (p<0.01). The clinical trial efficacy results from both studies are provided below.

{ "type": "p", "children": [], "text": "The co-primary efficacy endpoints were the proportion of subjects with Anterior Chamber Cell (ACC) count = 0 (ACC grade = 0) at POD8 maintained through POD15, and the proportion of subjects with Ocular Pain Grade = 0 at POD4 maintained through POD15. In the intent-to-treat analysis, both co-primary efficacy endpoints were statistically significantly better in BYQLOVI 0.05%-treated patients compared to vehicle-treated patients (p<0.01). The clinical trial efficacy results from both studies are provided below." }

<div class="scrollingtable"><table width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <thead> <tr class="First First Last Last"> <th align="left" colspan="2">Figure 1: Percent of Patients with Anterior Chamber Cell Count = 0 at Post-Operative Days 8 and 15</th> </tr> </thead> <tbody> <tr class="First First Last Last"> <td align="left"> <p class="First"> <img alt="Figure 1" src="/dailymed/image.cfm?name=clobetasol-02.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e"/></p> </td><td align="left"> <p class="First"> <img alt="Figure 1" src="/dailymed/image.cfm?name=clobetasol-03.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<thead>\n<tr class=\"First First Last Last\">\n<th align=\"left\" colspan=\"2\">Figure 1: Percent of Patients with Anterior Chamber Cell Count = 0 at Post-Operative Days 8 and 15</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First First Last Last\">\n<td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure 1\" src=\"/dailymed/image.cfm?name=clobetasol-02.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e\"/></p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure 1\" src=\"/dailymed/image.cfm?name=clobetasol-03.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="60%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <thead> <tr class="First First Last Last"> <th align="left" colspan="2">Figure 2: Percent of Patients with Complete Resolution of Pain at Post-Operative Days 4, 8, and 15</th> </tr> </thead> <tbody> <tr class="First First Last Last"> <td align="left"> <p class="First"> <img alt="Figure 2" src="/dailymed/image.cfm?name=clobetasol-04.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e"/></p> </td><td align="left"> <p class="First"> <img alt="Figure 2" src="/dailymed/image.cfm?name=clobetasol-05.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"60%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<thead>\n<tr class=\"First First Last Last\">\n<th align=\"left\" colspan=\"2\">Figure 2: Percent of Patients with Complete Resolution of Pain at Post-Operative Days 4, 8, and 15</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First First Last Last\">\n<td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure 2\" src=\"/dailymed/image.cfm?name=clobetasol-04.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e\"/></p>\n</td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Figure 2\" src=\"/dailymed/image.cfm?name=clobetasol-05.jpg&amp;setid=7687c980-7006-4222-80b9-c32773772d3e\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% (0.5 mg/mL) is a sterile ophthalmic suspension. It is supplied in a multi-dose white low-density polyethylene plastic 5 mL eye-dropper bottle with a low-density polyethylene white tip and a high-density polyethylene pink cap with a tamper-proof ring at the bottom of the cap.

3.5 mL in a 5 mL bottle (NDC 81046-0319-1)

Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, BYQLOVI can be used until the expiration date on the bottle.

Administration with Other Eye Drops

Advise patients to wait at least 5 minutes between instillation of BYQLOVI and other eye drops if using other eye drops in addition to BYQLOVI.

Risk of Contamination

Advise patients to wash their hands well before each use. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension.

When to Seek Physician Advice

Advise patients to consult a physician if pain develops; or if redness, itching, or inflammation becomes aggravated.

Contact Lens Wear

Advise patients that the preservative in BYQLOVI may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of BYQLOVI and may be reinserted after 15 minutes following administration.

Distributed by: Eyenovia, Inc. 295 Madison Avenue, Suite 2400 New York, NY 10017

{ "type": "p", "children": [], "text": "Distributed by: \n Eyenovia, Inc. \n 295 Madison Avenue, Suite 2400 \n New York, NY 10017\n " }

NDC #: 81046-0319-1

{ "type": "p", "children": [], "text": "NDC #: 81046-0319-1" }

BYQLOVI

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

(clobetasol propionate

{ "type": "p", "children": [], "text": "(clobetasol propionate" }

ophthalmic suspension)

{ "type": "p", "children": [], "text": "ophthalmic suspension)" }

0.05%

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

FOR TOPICAL APPLICATION IN THE EYE

{ "type": "p", "children": [], "text": "FOR TOPICAL \n APPLICATION IN THE EYE\n " }

Sterile Rx only

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

3.5 mL

{ "type": "p", "children": [], "text": "3.5 mL" }

eyenovia

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

Bottle Label

{ "type": "p", "children": [], "text": "Bottle Label" }

Carton Label

{ "type": "p", "children": [], "text": "Carton Label" }

Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.

{ "type": "p", "children": [], "text": "\nClobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older." }

Apply a thin layer of clobetasol propionate foam to the affected skin areas twice daily.

{ "type": "p", "children": [], "text": "\nApply a thin layer of clobetasol propionate foam to the affected skin areas twice daily." }

Clobetasol propionate foam is a super-high-potency topical corticosteroid; therefore, limit treatment to 2 consecutive weeks. Patients should not use greater than 50 grams per week or more than 21 capfuls per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Clobetasol propionate foam is a super-high-potency topical corticosteroid; therefore, limit treatment to 2 consecutive weeks. Patients should not use greater than 50 grams per week or more than 21 capfuls per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]." }

Therapy should be discontinued when control is achieved.

{ "type": "p", "children": [], "text": "Therapy should be discontinued when control is achieved." }

Clobetasol propionate foam should not be used with occlusive dressings unless directed by a physician.

{ "type": "p", "children": [], "text": "Clobetasol propionate foam should not be used with occlusive dressings unless directed by a physician." }

Clobetasol propionate foam is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

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

Avoid contact with eyes. Wash hands after each application.

{ "type": "p", "children": [], "text": "Avoid contact with eyes. Wash hands after each application." }

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site." }

Clobetasol propionate foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram.

{ "type": "p", "children": [], "text": "\nClobetasol propionate foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram." }

None.

{ "type": "p", "children": [], "text": "\nNone." }

Clobetasol propionate foam can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of clobetasol propionate foam on the HPA axis, 13 subjects applied clobetasol propionate foam to at least 20% of involved body surface area for 14 days. HPA axis suppression was identified in 5 out of 13 subjects (38%) [see Clinical Pharmacology (12.2)].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Cushing's syndrome and hyperglycemia may also occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

Use of topical corticosteroids, including clobetasol propionate foam, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products.

Avoid contact of clobetasol propionate foam with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

Clobetasol propionate 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 clinical practice.

In a controlled clinical trial involving 188 subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the subjects treated with clobetasol propionate foam. In 2 controlled clinical trials with clobetasol propionate foam in 360 subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the subjects treated with clobetasol propionate foam included application site burning (10%), application site dryness (<1%), and other application site reactions (4%).

In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

Because adverse 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.

Local adverse reactions to topical corticosteroids may include: striae, itching, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Ophthalmic adverse reactions may include: cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

Risk Summary

There are no available data on clobetasol propionate foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes.

Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible (see Data). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or 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 to 4% and 15 to 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 [adjusted RR, 7.74 (95% CI, 1.49 to 40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month (range, 12 to170 g) over long periods of time.

Animal Data

Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities.

In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

Risk Summary

There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate 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 clobetasol propionate foam and any potential adverse effects on the breastfed infant from clobetasol propionate foam or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate foam directly to the nipple and areola to avoid direct infant exposure.

Safety and effectiveness of clobetasol propionate foam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when they are treated with topical drugs. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic toxicities such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of clobetasol propionate foam in the treatment of diaper dermatitis.

Clinical studies of clobetasol propionate foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Clobetasol propionate foam, 0.05%, is a white to off white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use.

{ "type": "p", "children": [], "text": "\nClobetasol propionate foam, 0.05%, is a white to off white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use." }

Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

{ "type": "p", "children": [], "text": "Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity." }

Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, a molecular weight of 466.97.

{ "type": "p", "children": [], "text": "Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, a molecular weight of 466.97." }

The following is the chemical structure:

{ "type": "p", "children": [], "text": "The following is the chemical structure:" }

Clobetasol propionate is a white or almost white crystalline powder, practically insoluble in water.

{ "type": "p", "children": [], "text": "\nClobetasol propionate is a white or almost white crystalline powder, practically insoluble in water." }

Each gram of clobetasol propionate foam contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

{ "type": "p", "children": [], "text": "Each gram of clobetasol propionate foam contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant." }

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

In a controlled pharmacokinetic trial, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of therapy with clobetasol propionate foam applied to at least 20% of involved body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis was suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with clobetasol propionate foam (See Table 1 below).

<div class="scrollingtable"><table class="Noautorules" width="99%"> <caption> <span> Table 1: Subjects With Reversible HPA Axis Suppression at Any Time During Treatment </span> </caption> <col width="44%"/> <col width="55%"/> <tfoot> <tr> <td align="left" colspan="2"> <p class="First Footnote"> <span class="Sup">a </span>Clobetasol propionate foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of clobetasol propionate foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"> Dermatosis <br/> </td><td align="left" class="Botrule Rrule Toprule"> Clobetasol Propionate Foam<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Psoriasis <br/> </td><td align="left" class="Botrule Rrule"> 1 of 9 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Atopic Dermatitis<span class="Sup">a</span> <br/> </td><td align="left" class="Botrule Rrule"> 4 of 4 <br/> </td> </tr> </tbody> </table></div>

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

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

In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from 0.001% to 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol 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 for carcinogenesis.

Clobetasol propionate was nonmutagenic in the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. In the in vivo mouse micronucleus test, a positive finding was observed at 24 hours, but not at 48 hours, following oral administration at a dose of 2,000 mg/kg.

Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

A well-controlled clinical trial evaluated 188 subjects with moderate to severe scalp psoriasis. Subjects were treated twice daily for 2 weeks with one of 4 treatments: clobetasol propionate foam, vehicle foam, a commercially available clobetasol propionate solution (TEMOVATE® Scalp Application), or vehicle solution. The efficacy of clobetasol propionate foam in treating scalp psoriasis at the end of the 2 weeks' treatment was superior to that of vehicle (foam and solution), and was comparable to that of TEMOVATE Scalp Application (Table 2).

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span> Table 2. Efficacy Results From a Controlled Clinical Trial in Scalp Psoriasis </span> </caption> <col width="49%"/> <col width="31%"/> <col width="18%"/> <tfoot> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">a </span>Defined as a composite of an Investigator's Global Assessment of "completely clear " or "almost clear," a plaque thickness score of 0, an erythema score of 0 or 1, and a scaling score of 0 or 1 at endpoint, scored on a severity scale of 0 to 4.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Rrule Toprule" valign="top"> Clobetasol Propionate Foam<br/> n (%)<br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> Vehicle Foam<br/> n (%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Total number of subjects <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 62<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 31<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Subjects with treatment success<span class="Sup">a</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 39 (63)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 1 (3)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Subjects with parameter Clear at endpoint (scalp psoriasis)<br/> Scaling - Clear at endpoint <br/> </td><td align="center" class="Botrule Rrule" valign="bottom"> 42 (68)<br/> </td><td align="center" class="Botrule Rrule" valign="bottom"> 3 (10)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Erythema - Clear at endpoint <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 27 (44)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 2 (6)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Plaque Thickness - Clear at endpoint <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 41 (66)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 3 (10)<br/> </td> </tr> </tbody> </table></div>

Another well-controlled clinical trial evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean body surface area at baseline was 6.7% with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with clobetasol propionate foam or vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of clobetasol propionate foam in treating non-scalp psoriasis at the end of 2 weeks' treatment was superior to that of vehicle foam (Table 3).

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span> Table 3. Efficacy Results From a Controlled Clinical Trial in Non-scalp Psoriasis </span> </caption> <col width="49%"/> <col width="32%"/> <col width="17%"/> <tfoot> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">a </span>Defined as a composite of a Physician's Static Global Assessment score of 0 or 1, scaling score of 0 or 1, an erythema score of 0 or 1 and a plaque thickness score of 0, based on a severity scale of 0 to 5 at endpoint.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Rrule Toprule"> Clobetasol Propionate Foam<br/> n (%)<br/> </td><td align="center" class="Botrule Rrule Toprule"> Vehicle Foam<br/> n (%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Total number of subjects <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 139<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 140<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Subjects with treatment success<span class="Sup">a</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 39 (28)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 4 (3)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Physician's Static Global Assessment -Clear or almost clear at endpoint <br/> </td><td align="center" class="Botrule Rrule"> 94 (68)<br/> </td><td align="center" class="Botrule Rrule"> 30 (21)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Scaling - Clear or almost clear at endpoint <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 101 (73)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 42 (30)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Erythema - Clear or almost clear at endpoint <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 88 (63)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 35 (25)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Plaque Thickness - Clear at endpoint <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 44 (32)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 5 (4)<br/> </td> </tr> </tbody> </table></div>

Clobetasol propionate foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white to off white foam is available as follows:

<div class="scrollingtable"><table class="Noautorules" width="606"> <col width="302"/> <col width="304"/> <tbody class="Headless"> <tr> <td align="left"> Strength<br/> </td><td align="left"> NDC Number<br/> </td> </tr> <tr> <td align="left"> 50 g aluminum can<br/> </td><td align="left"> NDC 46708-707-50<br/> </td> </tr> <tr> <td align="left"> 100 g aluminum can<br/> </td><td align="left"> NDC 46708-707-31<br/> </td> </tr> </tbody> </table></div>

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

FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).

Keep out of reach of children.

See FDA-approved patient labeling (Patient Information and Instructions for Use)

{ "type": "p", "children": [], "text": "\nSee FDA-approved patient labeling (Patient Information and Instructions for Use)" }

Effects on Endocrine System

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

Clobetasol propionate foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including clobetasol propionate foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using Clobetasol propionate foam if surgery is contemplated [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Clobetasol propionate foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including clobetasol propionate foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using Clobetasol propionate foam if surgery is contemplated [see Warnings and Precautions (5.1)].\n" }

Ophthalmic Adverse Reactions

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

Advise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.2)]." }

Local Adverse Reactions

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

Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use [see Warnings and Precautions (5.3)]." }

Pregnancy

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

Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)]. " }

Lactation

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

Advise a woman to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].

{ "type": "p", "children": [], "text": "Advise a woman to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)]." }

Important Administration Instructions

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

Inform patients of the following:

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

{ "type": "ul", "children": [ "Avoid use of clobetasol propionate foam on the face, underarms, or groin areas unless directed by the physician.", "Do not occlude the treatment area with bandage or other covering, unless directed by the physician.", "Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.", "For proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin.", "Limit treatment to 2 consecutive weeks. Use no more than 50 grams of clobetasol propionate foam per week, or more than 21 capfuls per week.", "Avoid use of clobetasol propionate foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing.", "The product is flammable; avoid heat, flame, and smoking when applying this product.", "Do not use other corticosteroid-containing products without first consulting with the physician." ], "text": "" }

Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by:" }

Alembic Pharmaceuticals Limited

{ "type": "p", "children": [], "text": "\nAlembic Pharmaceuticals Limited\n" }

(Derma Division),

{ "type": "p", "children": [], "text": "(Derma Division)," }

Karakhadi, Vadodara 391450, India.

{ "type": "p", "children": [], "text": "Karakhadi, Vadodara 391450, India." }

Mfg. License No.: G/25/2216

{ "type": "p", "children": [], "text": "Mfg. License No.: G/25/2216" }

For additional information, call at 1-800-FDA-1088 or visit www.alembicusa.com.

{ "type": "p", "children": [], "text": "For additional information, call at 1-800-FDA-1088 or visit www.alembicusa.com." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span></span> </caption> <col width="100%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold"> Patient Information</span> <br/> <span class="Bold"> Clobetasol Propionate (kloe bay' ta sol proe' pee oh nate)</span> <br/> <span class="Bold"> Foam, 0.05%</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Important: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth, or vagina.</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What is clobetasol propionate foam?</span> <br/> Clobetasol propionate foam is a prescription corticosteroid medicine used in people 12 years of age and older for the treatment of:<br/> <ul class="Disc"> <li>moderate to severe plaque psoriasis of the scalp <span class="Bold"> and</span> </li> <li>mild to moderate plaque psoriasis of the skin except the face and areas where the skin may touch or rub together.</li> </ul> It is not known if clobetasol propionate foam is safe and effective in children under 12 years of age. Clobetasol propionate foam is not recommended in children under 12 years of age.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Before using clobetasol propionate foam, tell your healthcare provider about all of your medical conditions, including if you: </span> <br/> <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 clobetasol propionate 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 clobetasol propionate foam will harm your unborn baby. If you use clobetasol propionate foam during pregnancy, use clobetasol propionate foam on the smallest area of skin and for the shortest time needed.</li> <li>are breastfeeding or plan to breastfeed. It is not known if clobetasol propionate foam passes into your breast milk. If you use clobetasol propionate foam while breastfeeding, use clobetasol propionate foam on the smallest area of skin and for the shortest time needed. Do not apply clobetasol propionate foam directly to the nipple and areola to avoid getting clobetasol propionate foam into your baby's mouth.</li> </ul> Tell your healthcare provider about all the medicine you take including prescription or over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing a corticosteroid medicine during treatment with clobetasol propionate foam without talking to your healthcare provider first.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> How should I use clobetasol propionate foam?</span> <br/> <span class="Bold"> See the "Instructions for Use" for detailed information about the right way to apply clobetasol propionate foam.</span> <br/> <ul class="Disc"> <li>Use clobetasol propionate foam exactly as your healthcare provider tells you to use it.</li> <li>Apply a thin layer of clobetasol propionate foam to the affected skin areas 2 times each day.</li> <li>Avoid using clobetasol propionate foam on your face, underarms (armpits), groin area, or in areas with thinning skin (atrophy).</li> <li>Avoid using clobetasol propionate foam on skin in a diaper area.</li> <li>Do not bandage or cover your treated area unless your healthcare provider tells you to.</li> <li>Do not use clobetasol propionate foam for longer than 2 weeks in a row.</li> <li>You should not use more than 50 grams or 21 capfuls of clobetasol propionate foam in 1 week.</li> <li>Talk to your healthcare provider if your skin or scalp does not improve after 2 weeks of treatment with clobetasol propionate foam.</li> <li>Wash your hands after using clobetasol propionate foam.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What should I avoid while using clobetasol propionate foam?</span> <br/> <span class="Bold"> Clobetasol propionate foam is flammable.</span> Avoid heat, flame, or smoking during and right after you apply clobetasol propionate foam to your skin. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What are the possible side effects of clobetasol propionate foam?</span> <br/> <span class="Bold"> Clobetasol propionate foam may cause serious side effects, including:</span> <br/> <ul class="Disc"> <li> <span class="Bold"> Clobetasol propionate foam can pass through your skin.</span> Too much clobetasol propionate 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 the body is exposed to too much of the hormone cortisol.</li> <li> <span class="Bold"> High blood sugar (hyperglycemia)</span> </li> <li> <span class="Bold"> Vision problems.</span> Clobetasol propionate foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clobetasol propionate 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 effects of clobetasol propionate foam</span> include burning and skin reactions at the treated site. These are not all the possible side effects of clobetasol propionate foam.<br/> Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> How should I store clobetasol propionate foam?</span> <br/> <ul class="Disc"> <li>Store clobetasol propionate foam at room temperature between 68° to 77°F (20° to 25°C).</li> <li>Do not break through (puncture) the clobetasol propionate foam can.</li> <li>Never throw the can into a fire, even if the can is empty.</li> <li>Do not store clobetasol propionate foam near heat or store at temperatures above 120°F (49°C).</li> </ul> Keep clobetasol propionate foam and all medicines out of the reach of children<span class="Italics">. </span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> General information about the safe and effective use of clobetasol propionate foam.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient information leaflet. Do not use clobetasol propionate foam for a condition for which it was not prescribed. Do not give clobetasol propionate foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about clobetasol propionate foam that is written for health professionals.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What are the ingredients in clobetasol propionate foam?</span> <br/> <span class="Bold"> Active ingredient:</span> clobetasol propionate<br/> <span class="Bold"> Inactive ingredients:</span> cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.<br/> Manufactured by:<br/> <span class="Bold"> Alembic Pharmaceuticals Limited</span> <br/> (Derma Division),<br/> Karakhadi, Vadodara 391450, India.<br/> Mfg. License No.: G/25/2216<br/> For more information, call at 1-800-FDA-1088 .or visit www.alembicusa.com.<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Patient Information</span>\n<br/>\n<span class=\"Bold\"> Clobetasol Propionate (kloe bay' ta sol proe' pee oh nate)</span>\n<br/>\n<span class=\"Bold\"> Foam, 0.05%</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Important: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth, or vagina.</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What is clobetasol propionate foam?</span>\n<br/> Clobetasol propionate foam is a prescription corticosteroid medicine used in people 12 years of age and older for the treatment of:<br/>\n<ul class=\"Disc\">\n<li>moderate to severe plaque psoriasis of the scalp <span class=\"Bold\"> and</span>\n</li>\n<li>mild to moderate plaque psoriasis of the skin except the face and areas where the skin may touch or rub together.</li>\n</ul>\n It is not known if clobetasol propionate foam is safe and effective in children under 12 years of age. Clobetasol propionate foam is not recommended in children under 12 years of age.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Before using clobetasol propionate foam, tell your healthcare provider about all of your medical conditions, including if you: </span>\n<br/>\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 clobetasol propionate 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 clobetasol propionate foam will harm your unborn baby. If you use clobetasol propionate foam during pregnancy, use clobetasol propionate foam on the smallest area of skin and for the shortest time needed.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if clobetasol propionate foam passes into your breast milk. If you use clobetasol propionate foam while breastfeeding, use clobetasol propionate foam on the smallest area of skin and for the shortest time needed. Do not apply clobetasol propionate foam directly to the nipple and areola to avoid getting clobetasol propionate foam into your baby's mouth.</li>\n</ul>\n Tell your healthcare provider about all the medicine you take including prescription or over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing a corticosteroid medicine during treatment with clobetasol propionate foam without talking to your healthcare provider first.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> How should I use clobetasol propionate foam?</span>\n<br/>\n<span class=\"Bold\"> See the \"Instructions for Use\" for detailed information about the right way to apply clobetasol propionate foam.</span>\n<br/>\n<ul class=\"Disc\">\n<li>Use clobetasol propionate foam exactly as your healthcare provider tells you to use it.</li>\n<li>Apply a thin layer of clobetasol propionate foam to the affected skin areas 2 times each day.</li>\n<li>Avoid using clobetasol propionate foam on your face, underarms (armpits), groin area, or in areas with thinning skin (atrophy).</li>\n<li>Avoid using clobetasol propionate foam on skin in a diaper area.</li>\n<li>Do not bandage or cover your treated area unless your healthcare provider tells you to.</li>\n<li>Do not use clobetasol propionate foam for longer than 2 weeks in a row.</li>\n<li>You should not use more than 50 grams or 21 capfuls of clobetasol propionate foam in 1 week.</li>\n<li>Talk to your healthcare provider if your skin or scalp does not improve after 2 weeks of treatment with clobetasol propionate foam.</li>\n<li>Wash your hands after using clobetasol propionate foam.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What should I avoid while using clobetasol propionate foam?</span>\n<br/>\n<span class=\"Bold\"> Clobetasol propionate foam is flammable.</span> Avoid heat, flame, or smoking during and right after you apply clobetasol propionate foam to your skin. <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What are the possible side effects of clobetasol propionate foam?</span>\n<br/>\n<span class=\"Bold\"> Clobetasol propionate foam may cause serious side effects, including:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\"> Clobetasol propionate foam can pass through your skin.</span> Too much clobetasol propionate 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 the body is exposed to too much of the hormone cortisol.</li>\n<li>\n<span class=\"Bold\"> High blood sugar (hyperglycemia)</span>\n</li>\n<li>\n<span class=\"Bold\"> Vision problems.</span> Clobetasol propionate foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clobetasol propionate 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>\n Your healthcare provider may do certain blood tests to check for side effects.<br/>\n<span class=\"Bold\"> The most common side effects of clobetasol propionate foam</span> include burning and skin reactions at the treated site. These are not all the possible side effects of clobetasol propionate foam.<br/> Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> How should I store clobetasol propionate foam?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Store clobetasol propionate foam at room temperature between 68° to 77°F (20° to 25°C).</li>\n<li>Do not break through (puncture) the clobetasol propionate foam can.</li>\n<li>Never throw the can into a fire, even if the can is empty.</li>\n<li>Do not store clobetasol propionate foam near heat or store at temperatures above 120°F (49°C).</li>\n</ul>\n Keep clobetasol propionate foam and all medicines out of the reach of children<span class=\"Italics\">. </span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> General information about the safe and effective use of clobetasol propionate foam.</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient information leaflet. Do not use clobetasol propionate foam for a condition for which it was not prescribed. Do not give clobetasol propionate foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about clobetasol propionate foam that is written for health professionals.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What are the ingredients in clobetasol propionate foam?</span>\n<br/>\n<span class=\"Bold\"> Active ingredient:</span> clobetasol propionate<br/>\n<span class=\"Bold\"> Inactive ingredients:</span> cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.<br/> Manufactured by:<br/>\n<span class=\"Bold\"> Alembic Pharmaceuticals Limited</span>\n<br/> (Derma Division),<br/> Karakhadi, Vadodara 391450, India.<br/> Mfg. License No.: G/25/2216<br/> For more information, call at 1-800-FDA-1088 .or visit www.alembicusa.com.<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

Clobetasol Propionate (kloe bay' ta sol proe' pee oh nate)

{ "type": "p", "children": [], "text": "\nClobetasol Propionate (kloe bay' ta sol proe' pee oh nate)\n" }

Foam, 0.05%

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

Important: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth or vagina.

{ "type": "p", "children": [], "text": "\nImportant: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth or vagina." }

How to apply clobetasol propionate foam:

{ "type": "p", "children": [], "text": "\nHow to apply clobetasol propionate foam:\n" }

<div class="scrollingtable"><table class="Noautorules" width="60%"> <caption> <span></span> </caption> <col width="25%"/> <col width="74%"/> <tbody class="Headless"> <tr> <td align="left" rowspan="2" valign="top"><img alt="Image" src="/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-2.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf"/><br/> <span class="Bold">      Figure A</span> <br/> </td><td align="left" valign="top"><span class="Bold"> Step 1:</span> Remove the cap and save for further use.<br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold"> Step 2:</span> Before applying clobetasol propionate foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle. (see <span class="Bold"> Figure A</span> )<br/> </td> </tr> <tr> <td align="left" valign="top"><img alt="Image" src="/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-3.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf"/><br/>      <span class="Bold"> Figure B</span> <br/> </td><td align="left"><span class="Bold"> Step 3:</span> Turn the can upside down. Push the button to dispense a small amount of clobetasol propionate foam into the cap of the can, or on your affected skin area. (see <span class="Bold"> Figure B</span> ) This amount should be no more than 1½ capfuls, about the size of a golf ball.<br/> <ul class="Disc"> <li> <span class="Bold"> Do not</span> dispense clobetasol propionate foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.</li> <li>If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.</li> <li>If the can seems warm or the foam seems runny, run the can under cold water</li> </ul> </td> </tr> <tr> <td align="left" valign="top"><img alt="Image" src="/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-4.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf"/><br/>    <span class="Bold">   Figure C</span> <br/> <img alt="Image" src="/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-5.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf"/><br/>   <span class="Bold">   Figure D</span> <br/> </td><td align="left" valign="top"><span class="Bold"> Step 4: </span> Using your fingertips, gently massage a thin layer of clobetasol propionate foam into the affected skin areas until the foam disappears. (see <span class="Bold"> Figures C and D</span> )<br/> </td> </tr> <tr> <td align="left" valign="top"><img alt="Image" src="/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-6.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf"/><br/>   <span class="Bold">    Figure E</span> <br/> </td><td align="left" valign="top"><span class="Bold"> Step 5:</span> If you are treating areas with hair, such as the scalp, move any hair away so that the foam can be applied directly to the affected areas. (see <span class="Bold"> Figure E</span> )<br/> <ul class="Disc"> <li>Repeat until the affected areas are treated.</li> </ul> <span class="Bold"> Keep the foam away from your eyes, </span> as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your healthcare provider right away.<br/> </td> </tr> <tr> <td align="left" valign="top"><img alt="Image" src="/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-7.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf"/><br/>    <span class="Bold">  Figure F</span> <br/> </td><td align="left" valign="top"><span class="Bold"> Step 6:</span> Wash your hands after applying clobetasol propionate foam. (see<span class="Bold"> Figure F</span> )<br/> <ul class="Disc"> <li>Throw away any of the unused medicine that you dispensed out of the can.</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"60%\">\n<caption>\n<span></span>\n</caption>\n<col width=\"25%\"/>\n<col width=\"74%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" rowspan=\"2\" valign=\"top\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-2.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf\"/><br/>\n<span class=\"Bold\">      Figure A</span>\n<br/>\n</td><td align=\"left\" valign=\"top\"><span class=\"Bold\"> Step 1:</span> Remove the cap and save for further use.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\"> Step 2:</span> Before applying clobetasol propionate foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle. (see <span class=\"Bold\"> Figure A</span> )<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-3.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf\"/><br/>      <span class=\"Bold\"> Figure B</span>\n<br/>\n</td><td align=\"left\"><span class=\"Bold\"> Step 3:</span> Turn the can upside down. Push the button to dispense a small amount of clobetasol propionate foam into the cap of the can, or on your affected skin area. (see <span class=\"Bold\"> Figure B</span> ) This amount should be no more than 1½ capfuls, about the size of a golf ball.<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\"> Do not</span> dispense clobetasol propionate foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.</li>\n<li>If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.</li>\n<li>If the can seems warm or the foam seems runny, run the can under cold water</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-4.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf\"/><br/>    <span class=\"Bold\">   Figure C</span>\n<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-5.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf\"/><br/>   <span class=\"Bold\">   Figure D</span>\n<br/>\n</td><td align=\"left\" valign=\"top\"><span class=\"Bold\"> Step 4: </span> Using your fingertips, gently massage a thin layer of clobetasol propionate foam into the affected skin areas until the foam disappears. (see <span class=\"Bold\"> Figures C and D</span> )<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-6.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf\"/><br/>   <span class=\"Bold\">    Figure E</span>\n<br/>\n</td><td align=\"left\" valign=\"top\"><span class=\"Bold\"> Step 5:</span> If you are treating areas with hair, such as the scalp, move any hair away so that the foam can be applied directly to the affected areas. (see <span class=\"Bold\"> Figure E</span> )<br/>\n<ul class=\"Disc\">\n<li>Repeat until the affected areas are treated.</li>\n</ul>\n<span class=\"Bold\"> Keep the foam away from your eyes, </span> as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your healthcare provider right away.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=982087a2-6263-4470-9bef-a467b25f0fe4-83-7.jpg&amp;setid=6fc0d1ac-f357-4038-8004-263bfaed4eaf\"/><br/>    <span class=\"Bold\">  Figure F</span>\n<br/>\n</td><td align=\"left\" valign=\"top\"><span class=\"Bold\"> Step 6:</span> Wash your hands after applying clobetasol propionate foam. (see<span class=\"Bold\"> Figure F</span> )<br/>\n<ul class=\"Disc\">\n<li>Throw away any of the unused medicine that you dispensed out of the can.</li>\n</ul>\n</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": "\nThis Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Alembic Pharmaceuticals Limited

{ "type": "p", "children": [], "text": "\nAlembic Pharmaceuticals Limited\n" }

(Derma Division),

{ "type": "p", "children": [], "text": "(Derma Division), " }

Karakhadi, Vadodara 391450, India.

{ "type": "p", "children": [], "text": "Karakhadi, Vadodara 391450, India." }

Mfg. License No.: G/25/2216

{ "type": "p", "children": [], "text": "Mfg. License No.: G/25/2216" }

Revised: 04/2025

{ "type": "p", "children": [], "text": "Revised: 04/2025" }

NDC 46708-707-50

{ "type": "p", "children": [], "text": "\nNDC 46708-707-50\n" }

Clobetasol Propionate Foam, 0.05%

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

Rx only

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

50 grams

{ "type": "p", "children": [], "text": "\n50 grams\n" }

For Topical Use Only.

{ "type": "p", "children": [], "text": "\nFor Topical Use Only.\n" }

Not for Ophthalmic, Oral, or Intravaginal Use.

{ "type": "p", "children": [], "text": "\nNot for Ophthalmic, Oral, or Intravaginal Use.\n" }

Invert can and then press firmly to dispense.

{ "type": "p", "children": [], "text": "Invert can and then press firmly to dispense." }

Description: Clobetasol Propionate Foam, 0.05%, contains 0.5 mg of clobetasol propionate, USP per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

{ "type": "p", "children": [], "text": "\nDescription: Clobetasol Propionate Foam, 0.05%, contains 0.5 mg of clobetasol propionate, USP per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant." }

Usual Dosage: Use only as prescribed by your physician. See accompanying prescribing information.

{ "type": "p", "children": [], "text": "\nUsual Dosage: Use only as prescribed by your physician. See accompanying prescribing information." }

WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING

{ "type": "p", "children": [], "text": "\nWARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING\n" }

Clobetasol propionate cream USP, 0.05% (emollient) is a super-high potency corticosteroid indicated for:

Clobetasol propionate cream USP, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.

Clobetasol propionate cream USP, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.

Clobetasol propionate cream USP, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

The total dosage should not exceed 50 grams per week.

Avoid use if skin atrophy is present at the treatment site.

Apply a thin layer of Clobetasol propionate cream USP, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application.

{ "type": "p", "children": [], "text": "Apply a thin layer of Clobetasol propionate cream USP, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application." }

Clobetasol propionate cream USP, 0.05% (emollient) is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.

{ "type": "p", "children": [], "text": "Clobetasol propionate cream USP, 0.05% (emollient) is a super-high potency topical corticosteroid; therefore,\n \n treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.\n" }

In moderate to severe plaque-type psoriasis, Clobetasol propionate cream USP, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.

{ "type": "p", "children": [], "text": "In moderate to severe plaque-type psoriasis, Clobetasol propionate cream USP, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended." }

Clobetasol propionate cream USP, 0.05% (emollient) should not be used with occlusive dressings.

{ "type": "p", "children": [], "text": "Clobetasol propionate cream USP, 0.05% (emollient) should not be used with occlusive dressings." }

Cream, 0.05%. Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base.

{ "type": "p", "children": [], "text": "Cream, 0.05%. Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base." }

None

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

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 grams per day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. In a study including 12 subjects ages 18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment.

Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to 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.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [ see Use in Specific Populations (8.4)]

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, hypertrichosis, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing. If irritation develops, Clobetasol propionate cream, 0.05% (emollient) should be discontinued and appropriate therapy instituted.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Clobetasol propionate cream, 0.05% (emollient) should be discontinued until the infection has been adequately controlled.

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 controlled trials with clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia. The incidence of local adverse reactions reported in the trials with Clobetasol propionate cream, 0.05% (emollient) was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.

There are no adequate and well-controlled studies in pregnant women. Therefore, Clobetasol propionate cream, 0.05% (emollient) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity by this route; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 0.33 and 0.01 times, respectively, the human topical dose of Clobetasol propionate cream, 0.05% (emollient). Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.001 and 0.003 times, respectively, the human topical dose of Clobetasol propionate cream, 0.05% (emollient). Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

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. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol propionate cream, 0.05% (emollient) is administered to a nursing woman.

Safety and effectiveness of Clobetasol propionate cream, 0.05% (emollient) in pediatric patients have not been established and its use in pediatric patients under 12 years of age is not recommended. In a study including 12 subjects ages 18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment. Four-week HPA axis suppression studies with Clobetasol propionate cream, 0.05% (emollient) in pediatric subjects have not been conducted.

Because of a higher ratio of skin surface area to body mass, 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 glucocorticosteroid insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

The use of Clobetasol propionate cream, 0.05% (emollient) for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.

Clinical studies of Clobetasol propionate cream, 0.05% (emollient) did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.

Topically applied Clobetasol propionate cream, 0.05% (emollient) can be absorbed in sufficient amounts to produce systemic effects [ see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Topically applied Clobetasol propionate cream, 0.05% (emollient) can be absorbed in sufficient amounts to produce systemic effects [\n \n see Warnings and Precautions\n \n (5.1)].\n\n " }

Clobetasol propionate cream USP, 0.05% (emollient) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

{ "type": "p", "children": [], "text": "Clobetasol propionate cream USP, 0.05% (emollient) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity." }

Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:" }

Clobetasol propionate has the molecular formula C 25H 32ClFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

{ "type": "p", "children": [], "text": "Clobetasol propionate has the molecular formula C\n 25H\n 32ClFO\n 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.\n " }

Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base consisting of cetostearyl alcohol, isopropyl myristate, propylene glycol, polyoxyl 20 cetostearyl ether, dimethicone 350, citric acid, sodium citrate, purified water, and imidurea as a preservative.

{ "type": "p", "children": [], "text": "Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base consisting of cetostearyl alcohol, isopropyl myristate, propylene glycol, polyoxyl 20 cetostearyl ether, dimethicone 350, citric acid, sodium citrate, purified water, and imidurea as a preservative." }

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2.

Clobetasol propionate cream, 0.05% (emollient) is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

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

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

Mutagenesis Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Coli B WP2 fluctuation test.

Impairment of Fertility Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed no significant effect on the males. The females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, Clobetasol propionate cream, 0.05% (emollient) was applied to 5% to 10% of body surface area. In this trial, there were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after 4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal dysfunction.

{ "type": "p", "children": [], "text": "In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, Clobetasol propionate cream, 0.05% (emollient) was applied to 5% to 10% of body surface area. In this trial, there were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after 4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal dysfunction." }

Storage and Handling

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].                     

Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.

Inform patients using topical corticosteroids of the following information and instructions:

Distributed by: The J. Molner Company LLC,

{ "type": "p", "children": [], "text": "\nDistributed by:\n\nThe J. Molner Company LLC,\n " }

Jersey City, NJ 07302

{ "type": "p", "children": [], "text": "Jersey City, NJ 07302" }

Product of Canada

{ "type": "p", "children": [], "text": "Product of Canada" }

Rev. 02/2024

{ "type": "p", "children": [], "text": "Rev. 02/2024" }

PI064

{ "type": "p", "children": [], "text": "PI064" }

Package Label - Principal Display Panel – 15g Tube Carton

{ "type": "p", "children": [], "text": "\nPackage Label - Principal Display Panel – 15g Tube Carton\n" }

NDC 83148-064-15

{ "type": "p", "children": [], "text": "NDC 83148-064-15" }

Clobetasol Propionate Cream USP, 0.05% (Emollient)

{ "type": "p", "children": [], "text": "\nClobetasol Propionate Cream USP, 0.05% (Emollient)\n" }

FOR TOPICAL USE ONLY. Not for ophthalmic, oral, or intravaginal use.

{ "type": "p", "children": [], "text": "\nFOR TOPICAL USE ONLY.\n\nNot for ophthalmic, oral, or intravaginal use.\n" }

15 grams Rx only

{ "type": "p", "children": [], "text": "15 grams\n \n\nRx only\n" }

Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.

Patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].

Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. [see Use in Specific Populations (8.4)].

Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

Clobetasol propionate spray, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

{ "type": "p", "children": [], "text": "\nClobetasol propionate spray, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use." }

Clobetasol propionate spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely.

{ "type": "p", "children": [], "text": "Clobetasol propionate spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely." }

The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use more than 26 sprays per application or 52 sprays per day.

{ "type": "p", "children": [], "text": "The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use more than 26 sprays per application or 52 sprays per day." }

Clobetasol propionate spray, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with clobetasol propionate spray, 0.05%. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression.

{ "type": "p", "children": [], "text": "Clobetasol propionate spray, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with clobetasol propionate spray, 0.05%. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression." }

Unless directed by physician, clobetasol propionate spray, 0.05% should not be used with occlusive dressings.

{ "type": "p", "children": [], "text": "Unless directed by physician, clobetasol propionate spray, 0.05% should not be used with occlusive dressings." }

Spray, 0.05% w/w. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate in a clear, colorless liquid.

{ "type": "p", "children": [], "text": "\nSpray, 0.05% w/w. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate in a clear, colorless liquid." }

   None.

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

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, using the Cosyntropin Stimulation Test, clobetasol propionate spray, 0.05% demonstrated rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15 to 20%, respectively), in adult patients with moderate to severe plaque psoriasis (≥ 20% BSA). In these studies, HPA axis suppression was defined as serum cortisol level ≤ 18 mcg/dL 30-min post cosyntropin stimulation [see Clinical Pharmacology (12)].

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to 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.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4)]

Use of topical corticosteroids, including clobetasol propionate spray may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products [see Adverse Reactions (6.2)].

Avoid contact of clobetasol propionate spray with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of clobetasol propionate spray, 0.05% should be discontinued until the infection has been adequately controlled.

Clobetasol propionate spray, 0.05% is flammable; keep away from heat or flame.

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 controlled, clinical trials with clobetasol propionate spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with clobetasol propionate spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for clobetasol propionate spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.

<div class="scrollingtable"><table class="Noautorules" width="765"> <caption> <span> Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence) </span> </caption> <col width="420"/> <col width="203"/> <col width="142"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold"><span class="Underline">Adverse Reaction</span></span> <br/> </td><td align="center" class="Botrule Rrule Toprule"> Clobetasol Propionate<br/> 0.05% Spray<br/> (N=120)<br/> </td><td align="center" class="Botrule Rrule Toprule"> Vehicle Spray<br/> (N=120)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> System Organ Class<br/> </td><td align="center" class="Botrule Rrule"> <br/> </td><td align="center" class="Botrule Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> General disorders and administration site conditions<br/> </td><td align="center" class="Botrule Rrule"> 50 (42%)<br/> </td><td align="center" class="Botrule Rrule"> 56 (47%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Application site burning<br/> </td><td align="center" class="Botrule Rrule"> 48 (40%)<br/> </td><td align="center" class="Botrule Rrule"> 56 (47%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Application site dryness<br/> </td><td align="center" class="Botrule Rrule"> 2 (2%)<br/> </td><td align="center" class="Botrule Rrule"> 0 (0%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Application site irritation<br/> </td><td align="center" class="Botrule Rrule"> 1 (1%)<br/> </td><td align="center" class="Botrule Rrule"> 0 (0%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Application site pain<br/> </td><td align="center" class="Botrule Rrule"> 1 (1%)<br/> </td><td align="center" class="Botrule Rrule"> 2 (2%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Application site pigmentation changes<br/> </td><td align="center" class="Botrule Rrule"> 1 (1%)<br/> </td><td align="center" class="Botrule Rrule"> 0 (0%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Application site pruritus<br/> </td><td align="center" class="Botrule Rrule"> 4 (3%)<br/> </td><td align="center" class="Botrule Rrule"> 3 (3%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Infections and infestations<br/> </td><td align="center" class="Botrule Rrule"> 17 (14%)<br/> </td><td align="center" class="Botrule Rrule"> 12 (10%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Nasopharyngitis<br/> </td><td align="center" class="Botrule Rrule"> 6 (5%)<br/> </td><td align="center" class="Botrule Rrule"> 3 (3%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Pharyngitis streptococcal<br/> </td><td align="center" class="Botrule Rrule"> 1 (1%)<br/> </td><td align="center" class="Botrule Rrule"> 0 (0%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Upper respiratory tract infection<br/> </td><td align="center" class="Botrule Rrule"> 10 (8%)<br/> </td><td align="center" class="Botrule Rrule"> 2 (2%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Skin and subcutaneous tissue disorders<br/> </td><td align="center" class="Botrule Rrule"> 4 (3%)<br/> </td><td align="center" class="Botrule Rrule"> 2 (2%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Eczema asteatotic<br/> </td><td align="center" class="Botrule Rrule"> 2 (2%)<br/> </td><td align="center" class="Botrule Rrule"> 0 (0%)<br/> </td> </tr> </tbody> </table></div>

Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.

Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients.

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 post-approval use clobetasol propionate spray, 0.05%.

Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.

Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.

Risk Summary

There are no available data on clobetasol propionate spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids (see Data). Advise pregnant women that clobetasol propionate spray may increase the risk of having a low birth weight infant and to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible.

Animal reproduction studies have not been conducted with clobetasol propionate spray. In an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 mcg/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia) [see Data]. The available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of clobetasol propionate spray.

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

Data

Human Data

Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants.

Animal Data

Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused malformations in both the rabbit and the mouse.

Clobetasol propionate has greater potential for adverse developmental effects than steroids that are less potent.

The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no observed-adverse-effect-level (NOAEL) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOAEL in the dams was 25 mcg/kg/day based on prolonged delivery at 50 mcg/kg/day. The NOAEL for viability and growth in the offspring was 12.5 mcg/kg/day based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

Risk Summary

There is no information regarding the presence of clobetasol propionate in human milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of clobetasol propionate 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 clobetasol propionate spray and any potential adverse effects on the breastfed infant from clobetasol propionate spray or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate spray directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with clobetasol propionate spray, 0.05% have not been established [see Warnings and Precautions (5.1)].

Because of higher ratio of skin surface area to body mass, 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 glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Clinical studies of clobetasol propionate spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In two randomized, vehicle controlled clinical trials, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Topically applied clobetasol propionate spray, 0.05% can be absorbed in sufficient amount to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "\nTopically applied clobetasol propionate spray, 0.05% can be absorbed in sufficient amount to produce systemic effects [see Warnings and Precautions (5.1)]." }

Clobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17- propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7).

{ "type": "p", "children": [], "text": "\nClobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17- propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7)." }

The following is the chemical structure:

{ "type": "p", "children": [], "text": "The following is the chemical structure:" }

Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

{ "type": "p", "children": [], "text": "\nClobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid." }

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

Vasoconstrictor Assay

Clobetasol propionate spray, 0.05% is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

The effect of clobetasol propionate spray, 0.05% on hypothalamic-pituitary-adrenal (HPA) axis function was investigated in adults in two studies. In the first study, patients with plaque psoriasis covering at least 20% of their body applied clobetasol propionate spray, 0.05% twice daily for up to 4 weeks. 15% (2 out of 13) of patients displayed adrenal suppression after 4 weeks of use based on the Cosyntropin Stimulation Test. The laboratory suppression was transient; all subjects returned to normal after cessation of drug use. In the second study, patients with plaque psoriasis covering at least 20% of their body applied clobetasol propionate spray, 0.05% twice daily for either 2 or 4 weeks. 19% (4 out of 21) of patients treated for 2 weeks and 20% (3 out of 15) of patients treated for 4 weeks displayed adrenal suppression at the end of treatment based on the Cosyntropin Stimulation Test. The laboratory suppression was transient; all subjects returned to normal after cessation of drug use. In these studies, HPA axis suppression was defined as serum cortisol level ≤ 18 mcg/dL 30-min post cosyntropin (ACTH 1 to 24) stimulation [see Warnings and Precautions (5)].

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.

There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 mcg/kg/day.

Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.

The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 mcg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 mcg/kg/day clobetasol propionate was considered to be the NOAEL for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of fluid-filled seminal vesicles. The female reproductive NOAEL was 12.5 mcg/kg/day based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

The efficacy of clobetasol propionate spray, 0.05% in psoriasis has been demonstrated in two randomized, vehicle controlled clinical trials, which were identical in design. The studies were conducted in patients aged 18 years and older with moderate to severe plaque psoriasis. Patients were treated twice daily for up to 4 weeks with either clobetasol propionate spray, 0.05% or vehicle spray.

{ "type": "p", "children": [], "text": "\nThe efficacy of clobetasol propionate spray, 0.05% in psoriasis has been demonstrated in two randomized, vehicle controlled clinical trials, which were identical in design. The studies were conducted in patients aged 18 years and older with moderate to severe plaque psoriasis. Patients were treated twice daily for up to 4 weeks with either clobetasol propionate spray, 0.05% or vehicle spray." }

Patients were evaluated on their Overall Disease Severity, a 5-point scale based on scaling, erythema, and plaque elevation that classified subjects as clear, almost clear, mild, moderate, or severe/very severe. Only patients classified as moderate or severe/very severe at baseline were enrolled in the studies. The median percent body surface area (BSA) at baseline was 6% for the two studies. The numbers of patients scored as clear or almost clear at Weeks 2 and 4 are presented in Table 2.

{ "type": "p", "children": [], "text": "Patients were evaluated on their Overall Disease Severity, a 5-point scale based on scaling, erythema, and plaque elevation that classified subjects as clear, almost clear, mild, moderate, or severe/very severe. Only patients classified as moderate or severe/very severe at baseline were enrolled in the studies. The median percent body surface area (BSA) at baseline was 6% for the two studies. The numbers of patients scored as clear or almost clear at Weeks 2 and 4 are presented in Table 2." }

<div class="scrollingtable"><table class="Noautorules" width="765"> <caption> <span> Table 2-Number of Patients Clear or Almost Clear on the Overall Disease Severity Scale at Weeks 2 &amp; 4 </span> </caption> <col width="82"/> <col width="128"/> <col width="188"/> <col width="120"/> <col width="180"/> <col width="67"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2" rowspan="2" valign="top"> <br/> </td><td align="center" class="Rrule Toprule" colspan="2" valign="top"><span class="Bold"> Study 1</span> <br/> </td><td align="center" class="Rrule Toprule" colspan="2" valign="top"><span class="Bold"> Study 2</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule" valign="top"><span class="Bold"> Clobetasol propionate spray</span> <br/> <span class="Bold"> N=60</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top"><span class="Bold"> Vehicle</span> <br/> <span class="Bold"> N=60</span> <br/> </td><td align="left" class="Botrule" valign="top"><span class="Bold"> Clobetasol propionate spray</span> <br/> <span class="Bold"> N=60</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top"><span class="Bold"> Vehicle</span> <br/> <span class="Bold"> N=60</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule" valign="top"> Week 2<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Clear<br/> Almost Clear<br/> </td><td align="left" class="Botrule" valign="top"> 1 (2%)<br/> 32 (53%)<br/> </td><td align="left" class="Botrule Rrule" valign="top"> 0 (0%)<br/> 1 (2%)<br/> </td><td align="left" class="Botrule" valign="top"> 0 (0%)<br/> 28 (47%)<br/> </td><td align="left" class="Botrule Rrule" valign="top"> 0 (0%)<br/> 0 (0%)<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule" valign="top"> Week 4<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Clear<br/> Almost Clear<br/> </td><td align="left" class="Botrule" valign="top"> 15 (25%)<br/> 32 (53%)<br/> </td><td align="left" class="Botrule Rrule" valign="top"> 0 (0%)<br/> 2 (3%)<br/> </td><td align="left" class="Botrule" valign="top"> 18 (30%)<br/> 31 (52%)<br/> </td><td align="left" class="Botrule Rrule" valign="top"> 0 (0%)<br/> 1 (2%)<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"765\">\n<caption>\n<span> Table 2-Number of Patients Clear or Almost Clear on the Overall Disease Severity Scale at Weeks 2 &amp; 4 </span>\n</caption>\n<col width=\"82\"/>\n<col width=\"128\"/>\n<col width=\"188\"/>\n<col width=\"120\"/>\n<col width=\"180\"/>\n<col width=\"67\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" rowspan=\"2\" valign=\"top\">\n<br/>\n</td><td align=\"center\" class=\"Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> Study 1</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> Study 2</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\"> Clobetasol propionate spray</span>\n<br/>\n<span class=\"Bold\"> N=60</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"><span class=\"Bold\"> Vehicle</span>\n<br/>\n<span class=\"Bold\"> N=60</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\"> Clobetasol propionate spray</span>\n<br/>\n<span class=\"Bold\"> N=60</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"><span class=\"Bold\"> Vehicle</span>\n<br/>\n<span class=\"Bold\"> N=60</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\" valign=\"top\"> Week 2<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> Clear<br/> Almost Clear<br/>\n</td><td align=\"left\" class=\"Botrule\" valign=\"top\"> 1 (2%)<br/> 32 (53%)<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> 0 (0%)<br/> 1 (2%)<br/>\n</td><td align=\"left\" class=\"Botrule\" valign=\"top\"> 0 (0%)<br/> 28 (47%)<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> 0 (0%)<br/> 0 (0%)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\" valign=\"top\"> Week 4<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> Clear<br/> Almost Clear<br/>\n</td><td align=\"left\" class=\"Botrule\" valign=\"top\"> 15 (25%)<br/> 32 (53%)<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> 0 (0%)<br/> 2 (3%)<br/>\n</td><td align=\"left\" class=\"Botrule\" valign=\"top\"> 18 (30%)<br/> 31 (52%)<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> 0 (0%)<br/> 1 (2%)<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Clobetasol propionate spray, 0.05% is a clear, colorless liquid, supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes:

{ "type": "p", "children": [], "text": "\nClobetasol propionate spray, 0.05% is a clear, colorless liquid, supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes:" }

2 fl oz/59 mL NDC 46708-425-59

{ "type": "p", "children": [], "text": "2 fl oz/59 mL NDC 46708-425-59" }

4.25 fl oz/125 mL NDC 46708-425-12

{ "type": "p", "children": [], "text": "4.25 fl oz/125 mL NDC 46708-425-12" }

Storage: Keep tightly closed. Store under controlled room temperature conditions 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not freeze, refrigerate or store above 30°C. Spray is flammable; avoid heat, flame or smoking when using this product.

{ "type": "p", "children": [], "text": "\nStorage: Keep tightly closed. Store under controlled room temperature conditions 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not freeze, refrigerate or store above 30°C. Spray is flammable; avoid heat, flame or smoking when using this product." }

Patients using topical corticosteroids should receive the following information and instructions:

Patient Information

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

Clobetasol propionate (kloe bay' ta sol proe' pee oh nate) spray

{ "type": "p", "children": [], "text": "\nClobetasol propionate (kloe bay' ta sol proe' pee oh nate) spray\n" }

<div class="scrollingtable"><table class="Noautorules" width="998"> <col width="998"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold"> Important: For use on skin only. Do not get clobetasol propionate spray near or in your eyes, mouth or vagina.</span> <br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"998\">\n<col width=\"998\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Important: For use on skin only. Do not get clobetasol propionate spray near or in your eyes, mouth or vagina.</span>\n<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

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

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

What is clobetasol propionate spray?

{ "type": "p", "children": [], "text": "\nWhat is clobetasol propionate spray?\n" }

Clobetasol propionate spray is a prescription corticosteroid medicine used to treat adults with moderate to severe plaque psoriasis that affects up to 20% of the body's skin surface. Clobetasol propionate spray is for use on the skin only (topical).

{ "type": "p", "children": [], "text": "Clobetasol propionate spray is a prescription corticosteroid medicine used to treat adults with moderate to severe plaque psoriasis that affects up to 20% of the body's skin surface. Clobetasol propionate spray is for use on the skin only (topical)." }

{ "type": "ul", "children": [ "Clobetasol propionate spray should only be used for the shortest amount of time needed to treat your plaque psoriasis.", "Do not use more than 26 sprays for each application or more than 52 sprays in 1 day.", "You should not apply more than 59 mL (2 fluid ounces) of clobetasol propionate spray to your skin in 1 week." ], "text": "" }

You should not use clobetasol propionate spray:

{ "type": "p", "children": [], "text": "\nYou should not use clobetasol propionate spray:\n" }

{ "type": "ul", "children": [ "on your face, under arms (armpits), or groin areas", "if you have thinning of the skin (atrophy) at the treatment site", "to treat rosacea or a rash around the mouth (perioral dermatitis)" ], "text": "" }

It is not known if clobetasol propionate spray is safe and effective in children under 18 years of age. Clobetasol propionate spray should not be used in children under 18 years of age.

{ "type": "p", "children": [], "text": "\nIt is not known if clobetasol propionate spray is safe and effective in children under 18 years of age. Clobetasol propionate spray should not be used in children under 18 years of age." }

What should I tell my doctor before using clobetasol propionate spray?

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

Before you use clobetasol propionate spray, tell your doctor if you:

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

{ "type": "ul", "children": [ "have a skin infection. You may need medicine to treat the skin infection before you use clobetasol propionate spray.", "plan to have surgery.", "have any other medical conditions.", "are pregnant or plan to become pregnant. It is not known if clobetasol propionate spray will harm your unborn baby.", "are breast-feeding or plan to breast-feed. It is not known if clobetasol propionate spray passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use clobetasol propionate spray." ], "text": "" }

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

{ "type": "p", "children": [], "text": "\nTell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure." }

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

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

How should I use clobetasol propionate spray?

{ "type": "p", "children": [], "text": "\nHow should I use clobetasol propionate spray?\n" }

{ "type": "ul", "children": [ "Use clobetasol propionate spray exactly as your doctor tells you to use it.", "Your doctor should tell you how much clobetasol propionate spray to use and where to apply it.", "Clobetasol propionate spray is for use on skin only. Do not get clobetasol propionate spray near or in your eyes, mouth, or vagina.", "You should not use clobetasol propionate spray on your face, underarms (armpits), or groin areas.", "Apply clobetasol propionate spray 2 times each day.", "Apply only enough clobetasol propionate spray to cover the affected skin areas. Rub in gently and completely.", "Wash your hands after using clobetasol propionate spray.", "Throw away any unused clobetasol propionate spray.", "Do not bandage or cover your treated areas unless your doctor tells you to.", "Tell your doctor if your skin condition is not getting better after 2 weeks of using clobetasol propionate spray. Your doctor may tell you to apply clobetasol propionate spray to certain areas of your skin for up to 2 more weeks if needed. You should not use clobetasol propionate spray for more than 4 weeks unless your doctor tells you to. This can increase your risk of serious side effects." ], "text": "" }

See the "Instructions for Use" at the end of the Patient Information for detailed information on the right way to apply clobetasol propionate spray.

{ "type": "p", "children": [], "text": "\nSee the \"Instructions for Use\" at the end of the Patient Information for detailed information on the right way to apply clobetasol propionate spray." }

What should I avoid while using clobetasol propionate spray?

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

{ "type": "ul", "children": [ "\nClobetasol propionate spray is flammable. Avoid heat, flames or smoking while applying clobetasol propionate spray to your skin." ], "text": "" }

What are the possible side effects of clobetasol propionate spray?

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

{ "type": "ul", "children": [ "\nClobetasol propionate spray can pass through your skin. Too much clobetasol propionate spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working." ], "text": "" }

The most common side effects with clobetasol propionate spray include:

{ "type": "p", "children": [], "text": "\nThe most common side effects with clobetasol propionate spray include:\n" }

{ "type": "ul", "children": [ "burning at treated site", "upper respiratory tract infection", "runny nose", "sore throat", "dry, itchy and reddened skin" ], "text": "" }

If you go to another doctor for illness, injury or surgery, tell that doctor you are using clobetasol propionate spray.

{ "type": "p", "children": [], "text": "\nIf you go to another doctor for illness, injury or surgery, tell that doctor you are using clobetasol propionate spray. " }

Tell your doctor if you have any side effect that bothers you or that does not go away.

{ "type": "p", "children": [], "text": "Tell your doctor if you have any side effect that bothers you or that does not go away. " }

These are not all the possible side effects of clobetasol propionate spray. For more information, ask your doctor or pharmacist.

{ "type": "p", "children": [], "text": "These are not all the possible side effects of clobetasol propionate spray. 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." }

How should I store clobetasol propionate spray?

{ "type": "p", "children": [], "text": "\nHow should I store clobetasol propionate spray?\n" }

{ "type": "ul", "children": [ "Store clobetasol propionate spray at room temperature between 68°F to 77°F (20°C to 25°C).", "Do not store clobetasol propionate spray above 86°F (30°C).", "Do not freeze or refrigerate clobetasol propionate spray.", "Keep the bottle of clobetasol propionate spray tightly closed.", "Keep away from heat or flame." ], "text": "" }

Keep clobetasol propionate spray and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep clobetasol propionate spray and all medicines out of the reach of children.\n" }

General information about clobetasol propionate spray.

{ "type": "p", "children": [], "text": "\nGeneral information about clobetasol propionate spray.\n" }

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clobetasol propionate spray for a condition for which it was not prescribed. Do not give clobetasol propionate spray 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 a Patient Information leaflet. Do not use clobetasol propionate spray for a condition for which it was not prescribed. Do not give clobetasol propionate spray 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 clobetasol propionate spray. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about clobetasol propionate spray that is written for health professionals.

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

What are the ingredients of clobetasol propionate spray?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients of clobetasol propionate spray?\n" }

Active ingredient: clobetasol propionate.

{ "type": "p", "children": [], "text": "\nActive ingredient: clobetasol propionate. " }

Inactive ingredients: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

{ "type": "p", "children": [], "text": "\nInactive ingredients: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid." }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

Clobetasol propionate (kloe bay' ta sol proe' pee oh nate) spray

{ "type": "p", "children": [], "text": "\nClobetasol propionate (kloe bay' ta sol proe' pee oh nate) spray\n" }

<div class="scrollingtable"><table class="Noautorules" width="961"> <col width="961"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold"> Important: For use on skin only. Do not get clobetasol propionate spray near or in your mouth, eyes, or vagina.</span> <br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"961\">\n<col width=\"961\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Important: For use on skin only. Do not get clobetasol propionate spray near or in your mouth, eyes, or vagina.</span>\n<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Read the Instructions for Use that comes with clobetasol propionate spray before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "\nRead the Instructions for Use that comes with clobetasol propionate spray before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment." }

Parts of clobetasol propionate spray (See Figure A)

{ "type": "p", "children": [], "text": "\nParts of clobetasol propionate spray (See Figure A)" }

When you receive clobetasol propionate spray the Directional Spray Nozzle is in the "locked" position with the nozzle pointing downwards. (See Figure B)

{ "type": "p", "children": [], "text": "When you receive clobetasol propionate spray the Directional Spray Nozzle is in the \"locked\" position with the nozzle pointing downwards. (See Figure B)" }

How to apply clobetasol propionate spray:

{ "type": "p", "children": [], "text": "\nHow to apply clobetasol propionate spray:\n" }

Step 1: To unlock the Directional Spray Nozzle, hold the clobetasol propionate spray bottle and sides of the Pump Top with one hand. Use your other hand to turn the Directional Spray Nozzle to either the right or the left. (See Figure C) The spray will come out through the opening at the end of the Directional Spray Nozzle.

{ "type": "p", "children": [], "text": "\nStep 1: To unlock the Directional Spray Nozzle, hold the clobetasol propionate spray bottle and sides of the Pump Top with one hand. Use your other hand to turn the Directional Spray Nozzle to either the right or the left. (See Figure C) The spray will come out through the opening at the end of the Directional Spray Nozzle." }

Step 2: To apply clobetasol propionate spray, point the Directional Spray Nozzle to the affected area. To spray, push down on the Pump Top. Apply clobetasol propionate spray to the affected area as instructed by your doctor. (See Figure D)

{ "type": "p", "children": [], "text": "\nStep 2: To apply clobetasol propionate spray, point the Directional Spray Nozzle to the affected area. To spray, push down on the Pump Top. Apply clobetasol propionate spray to the affected area as instructed by your doctor. (See Figure D)" }

Step 3: Spray only enough clobetasol propionate spray to cover the affected area, for example, the elbow. (See Figure E) Rub in clobetasol propionate spray gently and completely.

{ "type": "p", "children": [], "text": "\nStep 3: Spray only enough clobetasol propionate spray to cover the affected area, for example, the elbow. (See Figure E) Rub in clobetasol propionate spray gently and completely." }

{ "type": "ul", "children": [ "You should not apply clobetasol propionate spray to your face, underarms or groin. Avoid contact with your eyes.", "To apply to your scalp, part your hair at the area where clobetasol propionate spray is to be applied. Spray directly on the affected area, and then rub in gently and completely. (See Figure F )", "Repeat Steps 2 and 3 to apply clobetasol propionate spray to other affected areas as instructed by your doctor" ], "text": "" }

Step 4: After applying clobetasol propionate spray, return the Directional Spray Nozzle to the "locked" position (See Figure G)

{ "type": "p", "children": [], "text": "\nStep 4: After applying clobetasol propionate spray, return the Directional Spray Nozzle to the \"locked\" position (See Figure G)" }

Step 5: Wash your hands after applying clobetasol propionate spray.

{ "type": "p", "children": [], "text": "\nStep 5: Wash your hands after applying clobetasol propionate spray. " }

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

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

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Alembic Pharmaceuticals Limited

{ "type": "p", "children": [], "text": "\nAlembic Pharmaceuticals Limited\n" }

(Derma Division),

{ "type": "p", "children": [], "text": "(Derma Division), " }

Karakhadi, Vadodara 391450, India.

{ "type": "p", "children": [], "text": "Karakhadi, Vadodara 391450, India." }

Mfg. License No.: G/25/2216

{ "type": "p", "children": [], "text": "Mfg. License No.: G/25/2216" }

Revised: 2/2025

{ "type": "p", "children": [], "text": "Revised: 2/2025" }

Rx Only

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

NDC 46708-425-59

{ "type": "p", "children": [], "text": "\nNDC 46708-425-59" }

Clobetasol Propionate Spray, 0.05%

{ "type": "p", "children": [], "text": "\nClobetasol Propionate Spray, 0.05%" }

For topical use only

{ "type": "p", "children": [], "text": "\nFor topical use only\n" }

2 FL OZ

{ "type": "p", "children": [], "text": "\n2 FL OZ\n" }

(59 mL)

{ "type": "p", "children": [], "text": "\n(59 mL)\n" }

Alembic

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

WARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION

{ "type": "p", "children": [], "text": "\nWARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION\n" }

Not for eye use.

{ "type": "p", "children": [], "text": "Not for eye use." }

Usual dosage: Apply twice daily, once in the morning and once at night.

{ "type": "p", "children": [], "text": "\nUsual dosage: Apply twice daily, once in the morning and once at night." }

Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the top of the carton.

{ "type": "p", "children": [], "text": "Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the top of the carton." }

TO THE PHARMACIST

{ "type": "p", "children": [], "text": "\nTO THE PHARMACIST\n" }

{ "type": "ul", "children": [ "\nEnsure the patient receives the Patient Information.\n", "\nReplace cap with spray pump prior to dispensing ." ], "text": "" }

Each gram contains: Active: clobetasol propionate (0.5 mg).

{ "type": "p", "children": [], "text": "\nEach gram contains: Active: clobetasol propionate (0.5 mg)." }

Inactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

{ "type": "p", "children": [], "text": "\nInactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid." }

Store at controlled room temperature 68° to 77°F (20° to 25°C); excursions permitted between 59° and 86°F (15° and 30°C).

{ "type": "p", "children": [], "text": "Store at controlled room temperature 68° to 77°F (20° to 25°C); excursions permitted between 59° and 86°F (15° and 30°C)." }

Protect from freezing.

{ "type": "p", "children": [], "text": "Protect from freezing." }

Do not refrigerate or store above 86°F (30°C).

{ "type": "p", "children": [], "text": "Do not refrigerate or store above 86°F (30°C)." }

Keep out of reach of children.

{ "type": "p", "children": [], "text": "Keep out of reach of children." }

Rx Only

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

NDC 46708-425-12

{ "type": "p", "children": [], "text": "\nNDC 46708-425-12" }

Clobetasol Propionate Spray, 0.05%

{ "type": "p", "children": [], "text": "\nClobetasol Propionate Spray, 0.05%" }

For topical use only

{ "type": "p", "children": [], "text": "\nFor topical use only\n" }

4.25 FL OZ

{ "type": "p", "children": [], "text": "\n4.25 FL OZ\n" }

(125 mL)

{ "type": "p", "children": [], "text": "\n(125 mL)\n" }

Alembic

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

WARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION

{ "type": "p", "children": [], "text": "\nWARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION\n" }

Not for eye use.

{ "type": "p", "children": [], "text": "Not for eye use." }

Usual dosage: Apply twice daily, once in the morning and once at night.

{ "type": "p", "children": [], "text": "\nUsual dosage: Apply twice daily, once in the morning and once at night." }

Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the top of the carton.

{ "type": "p", "children": [], "text": "Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the top of the carton." }

TO THE PHARMACIST

{ "type": "p", "children": [], "text": "\nTO THE PHARMACIST\n" }

{ "type": "ul", "children": [ "\nEnsure the patient receives the Patient Information.\n", "\nReplace cap with spray pump prior to dispensing ." ], "text": "" }

Each gram contains: Active: clobetasol propionate (0.5 mg).

{ "type": "p", "children": [], "text": "\nEach gram contains: Active: clobetasol propionate (0.5 mg)." }

Inactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

{ "type": "p", "children": [], "text": "\nInactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid." }

Store at controlled room temperature 68° to 77°F (20° to 25°C); excursions permitted between 59° and 86°F (15° and 30°C).

{ "type": "p", "children": [], "text": "Store at controlled room temperature 68° to 77°F (20° to 25°C); excursions permitted between 59° and 86°F (15° and 30°C)." }

Protect from freezing.

{ "type": "p", "children": [], "text": "Protect from freezing." }

Do not refrigerate or store above 86°F (30°C).

{ "type": "p", "children": [], "text": "Do not refrigerate or store above 86°F (30°C)." }

Keep out of reach of children.

{ "type": "p", "children": [], "text": "Keep out of reach of children." }

Clobetasol Propionate Shampoo, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.

Patients should be instructed to use Clobetasol Propionate Shampoo, 0.05% for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)].

Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

Clobetasol Propionate Shampoo, 0.05% should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.

Clobetasol Propionate Shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use." }

Clobetasol Propionate Shampoo, 0.05% should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05% should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing." }

The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.

{ "type": "p", "children": [], "text": "The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week." }

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying Clobetasol Propionate Shampoo, 0.05%.

{ "type": "p", "children": [], "text": "Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying Clobetasol Propionate Shampoo, 0.05%." }

Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

{ "type": "p", "children": [], "text": "Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired." }

Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with Clobetasol Propionate Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

{ "type": "p", "children": [], "text": "Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with Clobetasol Propionate Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary." }

Clobetasol Propionate Shampoo, 0.05% should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician.

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05% should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician." }

Shampoo, 0.05%, w/w. Each gram of Clobetasol Propionate Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid.

{ "type": "p", "children": [], "text": "Shampoo, 0.05%, w/w. Each gram of Clobetasol Propionate Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid." }

None

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

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05% applied once daily for 15 minutes to a dry scalp before lathering and rinsing.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to 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.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

If irritation develops, Clobetasol Propionate Shampoo, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing.

In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Clobetasol Propionate Shampoo, 0.05% should be discontinued until the infection has been adequately controlled.

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

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 clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.

Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.

<div class="scrollingtable"><table width="100%"> <col width="34%"/> <col width="42%"/> <col width="24%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Table 1: Summary of Selected Adverse Reactions ≥ 1% by Body System</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Body System</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Clobetasol Propionate Shampoo, 0.05%</p> <p>N=558</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Vehicle Shampoo</p> <p>N=127</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Skin and Appendages</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">49 (8.8%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">28 (22.0%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Discomfort Skin</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">26 (4.7%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">16 (12.6%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Pruritus</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (0.5%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9 (7.1%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Body As A Whole</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">33 (5.9%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12 (9.4%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Headache</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10 (1.8%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (0.8%)</p> </td> </tr> </tbody> </table></div>

Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

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 post-approval use of clobetasol propionate shampoo, 0.05%.

Teratogenic effects: Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol propionate shampoo, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse.

Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 μg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no-observed-effect-level (NOEL) for clobetasol propionate was less than 12.5 μg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 μg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring

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. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate shampoo, 0.05% is administered to a nursing woman.

Use of clobetasol propionate shampoo, 0.05% in patients under 18 years old is not recommended due to potential for HPA axis suppression [see Warnings and Precautions (5.1)]

The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only 1 of the 5 subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.

No studies have been performed in patients under the age of 12. Because of a higher ratio of skin surface area to body mass, 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 and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. Therefore, use is not recommended in patients under the age of 18.

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 of clobetasol propionate shampoo, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Topically applied, Clobetasol Propionate Shampoo, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]

{ "type": "p", "children": [], "text": "Topically applied, Clobetasol Propionate Shampoo, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]\n" }

Clobetasol Propionate Shampoo, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents." }

The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate.

{ "type": "p", "children": [], "text": "The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate." }

It has the following structural formula:

{ "type": "p", "children": [], "text": "It has the following structural formula:" }

Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7).

{ "type": "p", "children": [], "text": "Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7)." }

The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

{ "type": "p", "children": [], "text": "The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water." }

Each gram of Clobetasol Propionate Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid shampoo base consisting of alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

{ "type": "p", "children": [], "text": "Each gram of Clobetasol Propionate Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid shampoo base consisting of alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate." }

Like other topical corticosteroids, Clobetasol Propionate Shampoo, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Vasoconstrictor Assay

Clobetasol propionate shampoo, 0.05% is in the super-high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, use of clobetasol propionate shampoo, 0.05% resulted in demonstrable HPA axis suppression in 5 out of 12 (42%) adolescent subjects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.

There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis).

Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.

Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.

The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 μg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 μg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

The safety and efficacy of clobetasol propionate shampoo, 0.05% have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either clobetasol propionate shampoo, 0.05% or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below.

{ "type": "p", "children": [], "text": "The safety and efficacy of clobetasol propionate shampoo, 0.05% have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either clobetasol propionate shampoo, 0.05% or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below." }

<div class="scrollingtable"><table width="100%"> <col width="36%"/> <col width="15%"/> <col width="17%"/> <col width="14%"/> <col width="17%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Table 2: Efficacy Results</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">Clobetasol Propionate Shampoo, 0.05%</p> <p>N (%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">Shampoo Vehicle</p> <p>N (%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Study A</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Study B</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Study A</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Study B</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Total Number of Subjects</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">95</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">99</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">47</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">49</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Success Rate<span class="Sup">1 </span>at Endpoint<span class="Sup">2</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">40 (42.1%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">28 (28.3%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1 (2.1%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">5 (10.2%)</p> </td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="top"> <p class="First">Subjects with Scalp Psoriasis Parameter Clear (None) at Endpoint</p> </td><td class="Lrule Toprule" valign="middle"></td><td class="Toprule" valign="middle"></td><td class="Toprule" valign="middle"></td><td class="Rrule Toprule" valign="middle"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Erythema<span class="Sup">3</span> </p> </td><td align="center" class="Lrule" valign="middle"> <p class="First">17 (17.9%)</p> </td><td align="center" valign="middle"> <p class="First">12 (12.1%)</p> </td><td align="center" valign="middle"> <p class="First">3 (6.4%)</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">1 (2.0%)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Scaling<span class="Sup">3</span> </p> </td><td align="center" class="Lrule" valign="middle"> <p class="First">21 (22.1%)</p> </td><td align="center" valign="middle"> <p class="First">15 (15.2%)</p> </td><td align="center" valign="middle"> <p class="First">0 (0%)</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">2 (4.1%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Plaque Thickening<span class="Sup">3</span> </p> </td><td align="center" class="Botrule Lrule" valign="middle"> <p class="First">35 (36.8%)</p> </td><td align="center" class="Botrule" valign="middle"> <p class="First">34 (34.3%)</p> </td><td align="center" class="Botrule" valign="middle"> <p class="First">5 (10.6%)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">5 (10.2%)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"36%\"/>\n<col width=\"15%\"/>\n<col width=\"17%\"/>\n<col width=\"14%\"/>\n<col width=\"17%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Table 2: Efficacy Results</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Clobetasol Propionate Shampoo, 0.05%</p>\n<p>N (%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Shampoo Vehicle</p>\n<p>N (%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Study A</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Study B</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Study A</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Study B</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Total Number of Subjects</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">95</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">99</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">47</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">49</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Success Rate<span class=\"Sup\">1 </span>at Endpoint<span class=\"Sup\">2</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">40 (42.1%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">28 (28.3%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">1 (2.1%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">5 (10.2%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Subjects with Scalp Psoriasis Parameter Clear (None) at Endpoint</p>\n</td><td class=\"Lrule Toprule\" valign=\"middle\"></td><td class=\"Toprule\" valign=\"middle\"></td><td class=\"Toprule\" valign=\"middle\"></td><td class=\"Rrule Toprule\" valign=\"middle\"></td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Erythema<span class=\"Sup\">3</span>\n</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"middle\">\n<p class=\"First\">17 (17.9%)</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">12 (12.1%)</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">3 (6.4%)</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">1 (2.0%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Scaling<span class=\"Sup\">3</span>\n</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"middle\">\n<p class=\"First\">21 (22.1%)</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">15 (15.2%)</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">0 (0%)</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">2 (4.1%)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Plaque Thickening<span class=\"Sup\">3</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule\" valign=\"middle\">\n<p class=\"First\">35 (36.8%)</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">34 (34.3%)</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">5 (10.6%)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">5 (10.2%)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

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

Clinical studies of clobetasol propionate shampoo, 0.05% did not include sufficient numbers of non-Caucasian subjects to determine whether they respond differently than Caucasian subjects with regards to efficacy and safety.

{ "type": "p", "children": [], "text": "Clinical studies of clobetasol propionate shampoo, 0.05% did not include sufficient numbers of non-Caucasian subjects to determine whether they respond differently than Caucasian subjects with regards to efficacy and safety." }

Clobetasol Propionate Shampoo, 0.05% is a translucent, colorless viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05% is a translucent, colorless viscous liquid, supplied in 4 fl. oz. (118 mL) bottles." }

NDC: 72162-1442-2: 118 mL in a BOTTLE

{ "type": "p", "children": [], "text": "NDC: 72162-1442-2: 118 mL in a BOTTLE" }

Storage:

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

Keep bottle tightly closed. Store at USP controlled room temperature 68° to 77°F (20° - 25°C), with excursions permitted between 59° and 86°F (15° - 30°C).

{ "type": "p", "children": [], "text": "Keep bottle tightly closed. Store at USP controlled room temperature 68° to 77°F (20° - 25°C), with excursions permitted between 59° and 86°F (15° - 30°C)." }

Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504

{ "type": "p", "children": [], "text": "Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504" }

See FDA-approved patient labeling (Patient Information)

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

Information for Patients

{ "type": "p", "children": [], "text": "\nInformation for Patients\n" }

Inform the patient using topical corticosteroids to adhere to the following instructions:

{ "type": "p", "children": [], "text": "Inform the patient using topical corticosteroids to adhere to the following instructions:" }

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

Manufactured by Padagis®

{ "type": "p", "children": [], "text": "Manufactured by Padagis®\n" }

Yeruham, Israel

{ "type": "p", "children": [], "text": "Yeruham, Israel" }

www.padagis.com

{ "type": "p", "children": [], "text": "www.padagis.com" }

Rev 05-24

{ "type": "p", "children": [], "text": "Rev 05-24" }

6A900 RC PH2

{ "type": "p", "children": [], "text": "6A900 RC PH2" }

Clobetasol Propionate Shampoo, 0.05%

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05%" }

Important: For use on the scalp only. Do not get Clobetasol Propionate Shampoo, 0.05% near or in your eyes, mouth or vagina.

{ "type": "p", "children": [], "text": "\nImportant: For use on the scalp only. Do not get Clobetasol Propionate Shampoo, 0.05% near or in your eyes, mouth or vagina." }

Read the Patient Information that comes with Clobetasol Propionate Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "Read the Patient Information that comes with Clobetasol Propionate Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment." }

What is Clobetasol Propionate Shampoo, 0.05%?

{ "type": "p", "children": [], "text": "\nWhat is Clobetasol Propionate Shampoo, 0.05%?\n" }

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You should not use Clobetasol Propionate Shampoo, 0.05%:

{ "type": "p", "children": [], "text": "\nYou should not use Clobetasol Propionate Shampoo, 0.05%:\n" }

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

What should I tell my doctor before using Clobetasol Propionate Shampoo, 0.05%?

{ "type": "p", "children": [], "text": "\nWhat should I tell my doctor before using Clobetasol Propionate Shampoo, 0.05%?\n" }

Before you use Clobetasol Propionate Shampoo, 0.05%, tell your doctor if you:

{ "type": "p", "children": [], "text": "\nBefore you use Clobetasol Propionate Shampoo, 0.05%, tell your doctor if you:\n" }

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using Clobetasol Propionate Shampoo, 0.05%. Ask your doctor or pharmacist if you are not sure.

{ "type": "p", "children": [], "text": "\nTell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using Clobetasol Propionate Shampoo, 0.05%. Ask your doctor or pharmacist if you are not sure." }

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

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

How should I use Clobetasol Propionate Shampoo, 0.05%?

{ "type": "p", "children": [], "text": "\nHow should I use Clobetasol Propionate Shampoo, 0.05%?\n" }

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

See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to use Clobetasol Propionate Shampoo, 0.05%.

{ "type": "p", "children": [], "text": "See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to use Clobetasol Propionate Shampoo, 0.05%." }

What are the possible side effects of Clobetasol Propionate Shampoo, 0.05%?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of Clobetasol Propionate Shampoo, 0.05%?\n" }

Clobetasol Propionate Shampoo, 0.05% can pass through your skin. Too much Clobetasol Propionate Shampoo, 0.05% passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

{ "type": "p", "children": [], "text": "\nClobetasol Propionate Shampoo, 0.05% can pass through your skin. Too much Clobetasol Propionate Shampoo, 0.05% passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working." }

The most common side effects of Clobetasol Propionate Shampoo, 0.05% include:

{ "type": "p", "children": [], "text": "\nThe most common side effects of Clobetasol Propionate Shampoo, 0.05% include:\n" }

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

If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clobetasol Propionate Shampoo, 0.05%.

{ "type": "p", "children": [], "text": "If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clobetasol Propionate Shampoo, 0.05%." }

Tell your doctor if you have any side effect that bothers you or that does not go away.

{ "type": "p", "children": [], "text": "Tell your doctor if you have any side effect that bothers you or that does not go away." }

These are not all the possible side effects of Clobetasol Propionate Shampoo, 0.05%. For more information, ask your doctor or pharmacist.

{ "type": "p", "children": [], "text": "These are not all the possible side effects of Clobetasol Propionate Shampoo, 0.05%. 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 Padagis® at 1-866-634-9120

{ "type": "p", "children": [], "text": "You may also report side effects to Padagis® at 1-866-634-9120" }

How should I store Clobetasol Propionate Shampoo, 0.05%?

{ "type": "p", "children": [], "text": "\nHow should I store Clobetasol Propionate Shampoo, 0.05%?\n" }

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

Keep Clobetasol Propionate Shampoo, 0.05% and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep Clobetasol Propionate Shampoo, 0.05% and all medicines out of the reach of children.\n" }

General information about Clobetasol Propionate Shampoo, 0.05%

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Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clobetasol Propionate Shampoo, 0.05% for a condition for which it was not prescribed. Do not give Clobetasol Propionate Shampoo, 0.05% 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 a Patient Information leaflet. Do not use Clobetasol Propionate Shampoo, 0.05% for a condition for which it was not prescribed. Do not give Clobetasol Propionate Shampoo, 0.05% 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 Clobetasol Propionate Shampoo, 0.05%. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clobetasol Propionate Shampoo, 0.05% that is written for health professionals.

{ "type": "p", "children": [], "text": "This Patient Information leaflet summarizes the most important information about Clobetasol Propionate Shampoo, 0.05%. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clobetasol Propionate Shampoo, 0.05% that is written for health professionals." }

What are the ingredients in Clobetasol Propionate Shampoo, 0.05%?

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Active ingredient: clobetasol propionate

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Inactive ingredients (shampoo base): alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

{ "type": "p", "children": [], "text": "Inactive ingredients (shampoo base): alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate." }

Clobetasol Propionate Shampoo, 0.05%

{ "type": "p", "children": [], "text": "Clobetasol Propionate Shampoo, 0.05%" }

<div class="scrollingtable"><table width="100%"> <col width="100%"/> <tbody class="Headless"> <tr class="First Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Important: </span>For use on the scalp only. Do not get Clobetasol Propionate Shampoo, 0.05% near or in your eyes, mouth or vagina.</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 Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important: </span>For use on the scalp only. Do not get Clobetasol Propionate Shampoo, 0.05% near or in your eyes, mouth or vagina.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Read the Instructions for Use that comes with Clobetasol Propionate Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "Read the Instructions for Use that comes with Clobetasol Propionate Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment." }

How to apply Clobetasol Propionate Shampoo, 0.05% to your scalp:

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Your hair should be dry when you apply Clobetasol Propionate Shampoo, 0.05% to your scalp.

{ "type": "p", "children": [], "text": "\nYour hair should be dry when you apply Clobetasol Propionate Shampoo, 0.05% to your scalp.\n" }

Do not get Clobetasol Propionate Shampoo, 0.05% on your face, in your eyes or on your lips. If Clobetasol Propionate Shampoo, 0.05% does get on these areas, rinse well with water.

{ "type": "p", "children": [], "text": "\nDo not get Clobetasol Propionate Shampoo, 0.05% on your face, in your eyes or on your lips. If Clobetasol Propionate Shampoo, 0.05% does get on these areas, rinse well with water." }

Step 1: To apply Clobetasol Propionate Shampoo, 0.05% to your scalp, part your hair at the area where it is to be applied.

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Step 2: Hold the bottle of Clobetasol Propionate Shampoo, 0.05% over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.

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Step 3: Gently rub Clobetasol Propionate Shampoo, 0.05% into the affected area so that only the affected area is covered with a thin, even layer of Clobetasol Propionate Shampoo, 0.05%.

{ "type": "p", "children": [], "text": "\nStep 3: Gently rub Clobetasol Propionate Shampoo, 0.05% into the affected area so that only the affected area is covered with a thin, even layer of Clobetasol Propionate Shampoo, 0.05%." }

Step 4: Repeat Steps 1 through 3 to apply Clobetasol Propionate Shampoo, 0.05% to other affected areas on your scalp as instructed by your doctor.

{ "type": "p", "children": [], "text": "\nStep 4: Repeat Steps 1 through 3 to apply Clobetasol Propionate Shampoo, 0.05% to other affected areas on your scalp as instructed by your doctor." }

Step 5: Wash your hands after applying Clobetasol Propionate Shampoo, 0.05%.

{ "type": "p", "children": [], "text": "\nStep 5: Wash your hands after applying Clobetasol Propionate Shampoo, 0.05%." }

Step 6: Leave Clobetasol Propionate Shampoo, 0.05% on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while Clobetasol Propionate Shampoo, 0.05% is on your scalp, unless your doctor tells you to.

{ "type": "p", "children": [], "text": "\nStep 6: Leave Clobetasol Propionate Shampoo, 0.05% on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while Clobetasol Propionate Shampoo, 0.05% is on your scalp, unless your doctor tells you to." }

Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with Clobetasol Propionate Shampoo, 0.05%, such as your hands, face, neck and shoulders.

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No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using Clobetasol Propionate Shampoo, 0.05%.

{ "type": "p", "children": [], "text": "No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using Clobetasol Propionate Shampoo, 0.05%." }

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

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Manufactured by Padagis®

{ "type": "p", "children": [], "text": "Manufactured by Padagis®\n" }

Yeruham, Israel

{ "type": "p", "children": [], "text": "Yeruham, Israel" }

www.padagis.com

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Rev 05-24

{ "type": "p", "children": [], "text": "Rev 05-24" }

6A900 RC PH2

{ "type": "p", "children": [], "text": "6A900 RC PH2" }

ClobetasolShampoo 0.05% #118

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