NDC 0378-8055 Clobetasol Propionate

Clobetasol Propionate

NDC Product Code 0378-8055

NDC Code: 0378-8055

Proprietary Name: Clobetasol Propionate Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Clobetasol Propionate Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 0378 - Mylan Pharmaceuticals Inc.
    • 0378-8055 - Clobetasol Propionate

NDC 0378-8055-01

Package Description: 1 CAN in 1 CARTON > 100 g in 1 CAN

NDC Product Information

Clobetasol Propionate with NDC 0378-8055 is a a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The generic name of Clobetasol Propionate is clobetasol propionate. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Mylan Pharmaceuticals Inc.

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Clobetasol Propionate Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CLOBETASOL PROPIONATE .5 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mylan Pharmaceuticals Inc.
Labeler Code: 0378
FDA Application Number: NDA022013 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-14-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Clobetasol Topical

Clobetasol Topical is pronounced as (kloe bay' ta sol)

Why is clobetasol topical medication prescribed?
Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and skin conditions, including psorias...
[Read More]

* Please review the disclaimer below.

Clobetasol Propionate Product Label Images

Clobetasol Propionate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Clobetasol propionate foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.

2 Dosage And Administration

  • •Apply a thin layer of clobetasol propionate foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. •The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. •For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. •Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. •Clobetasol propionate foam is not for oral, ophthalmic, or intravaginal use. •Avoid contact with the eyes. •Avoid use on face, axillae, and groin, or if skin atrophy is present at the treatment site. •Wash hands after each application.

3 Dosage Forms And Strengths

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

4 Contraindications

None.

5.1 Effects On Endocrine System

Clobetasol propionate foam has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.Systemic absorption of clobetasol propionate has caused reversible HPA axis suppression with the potential for clinical glucocorticoid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Use of clobetasol propionate foam for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1)].In a trial including 37 subjects ages 12 years and older with atopic dermatitis of at least 30% body surface area (BSA), adrenal suppression was identified in 6 out of 37 subjects (16.2%) after 2 weeks of treatment with clobetasol propionate [see Clinical Pharmacology (12.2)].Because of the potential for systemic absorption, use of clobetasol propionate 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 adrenocorticotrophic 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 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 1 corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface-to-body mass ratios [see Use in Specific Populations (8.4)].

5.2 Local Adverse Reactions With Topical Corticosteroids

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.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.If irritation develops, treatment with clobetasol propionate foam should be discontinued and appropriate therapy instituted.

5.3 Ophthalmic Adverse Reactions

Use of topical corticosteroids, including clobetasol propionate foam, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroids, including topical clobetasol products [see Adverse Reactions (6.2)]. Avoid contact of clobetasol propionate foam with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.4 Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, clobetasol propionate foam should be discontinued until the infection has been adequately treated.

5.5 Flammable Contents

The propellant in clobetasol propionate foam is flammable. Avoid fire, flame, or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

6 Adverse Reactions

  • The following adverse reactions are discussed in greater detail in other sections of the labeling: •Effects on Endocrine System [see Warnings and Precautions (5.1)] •Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

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 clinical trials involving 821 subjects exposed to clobetasol propionate foam and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with clobetasol propionate foam was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender.

6.2 Postmarketing Experience

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 formulations: erythema, pruritus, burning, alopecia, and dryness.The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate.Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.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 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.

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 could 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.

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, 1.49–40.11]). 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, 12–170 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.

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.

8.4 Pediatric Use

Use in pediatric patients younger than 12 years is not recommended because of the risk of HPA axis suppression.After two weeks of twice-daily treatment with clobetasol propionate foam, 7 of 15 subjects (47%) aged 6 to 11 years demonstrated HPA axis suppression. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post-treatment.In 92 subjects aged 12 to 17 years, safety was similar to that observed in the adult population. Based on these data, no adjustment of dosage of clobetasol propionate foam in adolescent patients aged 12 to 17 years is warranted [see Warnings and Precautions (5.1)].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.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 (in infants), headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children.

8.5 Geriatric Use

A limited number of subjects aged 65 years or older have been treated with clobetasol propionate foam (n = 58) in U.S. clinical trials. While the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger subjects. Based on available data, no adjustment of dosage of clobetasol propionate foam in geriatric patients is warranted.

10 Overdosage

Topically applied clobetasol propionate foam can be absorbed in sufficient amounts to produce systemic effects.

11 Description

Clobetasol propionate foam, is a white to off-white petrolatum-based emulsion aerosol foam, containing the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. 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-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97.The following is the chemical structure:Clobetasol propionate is a white to 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 anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative.Clobetasol propionate foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.

12.1 Mechanism Of Action

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.

12.2 Pharmacodynamics

In a trial evaluating the potential for HPA axis suppression, using the cosyntropin stimulation test, clobetasol propionate foam demonstrated reversible adrenal suppression after two weeks of twice-daily use in subjects with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects aged 12 years and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this trial HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30 minutes post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].

12.3 Pharmacokinetics

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 increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. 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.Following twice-daily application of clobetasol propionate foam for one week to 32 adult subjects with mild to moderate plaque-type psoriasis, mean peak plasma concentrations (±SD) of 59 ± 36 pg/mL of clobetasol were observed at around 5 hours post dose on Day 8.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

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 non-mutagenic 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.

14 Clinical Studies

In a randomized trial of subjects 12 years and older with moderate to severe atopic dermatitis, 251 subjects were treated with clobetasol propionate foam and 126 subjects were treated with vehicle foam. Subjects were treated twice daily for 2 weeks. At the end of treatment, 131 of 251 subjects (52%) treated with clobetasol propionate foam compared with 18 of 126 subjects (14%) treated with vehicle foam achieved treatment success. Treatment success was defined by an Investigator’s Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, and scores of absent or minimal (0 or 1) for erythema and induration/papulation.In an additional randomized trial of subjects 12 years and older with mild to moderate plaque-type psoriasis, 253 subjects were treated with clobetasol propionate foam and 123 subjects were treated with vehicle foam. Subjects were treated twice daily for 2 weeks. At the end of treatment, 41 of 253 subjects (16%) treated with clobetasol propionate foam compared with 5 of 123 subjects (4%) treated with vehicle foam achieved treatment success. Treatment success was defined by an ISGA score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, scores of none or faint/minimal (0 or 1) for erythema and scaling, and a score of none (0) for plaque thickness.

16.1 How Supplied

Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white emulsion aerosol foam is available as follows:NDC 0378-8055-5050 g aluminum canNDC 0378-8055-01100 g aluminum can

16.2 Storage And Handling

Store at 20° to 25°C (68° to 77°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.

17 Patient Counseling Information

  • See FDA-Approved Patient Labeling (Patient Information)Effects on Endocrine SystemClobetasol 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)].Ophthalmic Adverse ReactionsAdvise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.3)].Local Adverse ReactionsReport 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 (5.2)].PregnancyAdvise a pregnant woman that use of clobetasol propionate foam may cause fetal harm 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)].LactationAdvise 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 InstructionsPatients using topical corticosteroids should receive the following information and instructions: •This medication is to be used as directed by the physician. It is for external use only. Unless directed by the prescriber, it should not be used on the face or in skin-fold areas, such as the underarms or groin. Avoid contact with the eyes or other mucous membranes. Wash hands after use. •As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. •Do not use for more than 50 grams per week of clobetasol propionate foam, or an amount greater than 21 capfuls per week. [see Dosage and Administration (2).] •This medication is flammable; avoid heat, flame, or smoking when applying this product.

Patient Information

  • Clobetasol Propionate FoamImportant: For skin use only. Do not get clobetasol propionate foam in your eyes, mouth, or vagina.What is clobetasol propionate foam?Clobetasol propionate foam is a prescription corticosteroid medicine used on the skin (topical) to treat people 12 years of age and older with certain skin conditions that cause red, flaky, and itchy skin.Clobetasol propionate foam is not recommended for use in children under 12 years of age. Clobetasol propionate foam should not be used: •on your face, underarms, or groin area •if you have skin thinning (atrophy) at the treatment areaYou should not use clobetasol propionate foam for longer than 2 weeks in a row.You should not use more than 50 grams or 21 capfuls of clobetasol propionate foam in 1 week.Before using clobetasol propionate foam, tell your healthcare provider about all of your medical conditions, including if you: •have had irritation or other skin reaction to a steroid medicine in the past. •have a skin infection. You may need medicine to treat the skin infection before using clobetasol propionate foam. •have diabetes. •have adrenal gland problems. •have liver problems. •plan to have surgery. •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. •are breastfeeding or plan to breastfeed. It is not known if clobetasol propionate 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. Tell your healthcare provider about all the medicine you take including prescription and 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.How should I use clobetasol propionate foam?See the “Instructions for Use” for detailed information about the right way to apply clobetasol propionate foam. •Use clobetasol propionate foam exactly as your healthcare provider tells you to use it. •Apply a thin layer of clobetasol propionate foam to the affected area 2 times each day, 1 time in the morning and 1 time at night, or as directed by your healthcare provider. •Do not bandage, wrap or cover your treated area unless your healthcare provider tells you to. •Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with clobetasol propionate foam. Wash your hands after using clobetasol propionate foam.What should I avoid while using clobetasol propionate foam?Clobetasol propionate foam is flammable. Avoid heat, flame, or smoking during and right after you apply clobetasol propionate foam to your skin.What are the possible side effects of clobetasol propionate foam?Clobetasol propionate foam may cause serious side effects, including: •Clobetasol propionate foam can pass through your skin. Too much clobetasol propionate foam passing through your skin can cause adrenal glands to stop working. •Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol. •High blood sugar (hyperglycemia) •Vision problems. 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 your treatment with clobetasol propionate foam. •Skin reactions at the treated site. Tell your healthcare provider if you get any skin reactions or skin infections. •Effects on growth and weight in children.Your healthcare provider may do certain blood tests to check for side effects. The most common side effects of clobetasol propionate foam include: •thinning of skin •burning •redness •itching •drynessThese are not all the side effects of clobetasol propionate foam. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store clobetasol propionate foam? •Store clobetasol propionate foam at room temperature between 68° to 77°F (20° to 25°C). •Do not break through (puncture) clobetasol propionate foam can. •Never throw the can into a fire, even if the can is empty. •Do not store clobetasol propionate foam near heat or at temperatures above 120°F (49°C).Keep clobetasol propionate foam and all medicines out of the reach of children.General information about the safe and effective use of clobetasol propionate foamMedicines 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.What are the ingredients in clobetasol propionate foam?Active ingredient: clobetasol propionateInactive ingredients: anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative, pressurized with a hydrocarbon (propane/butane) propellant.Manufactured for: Mylan Pharmaceuticals Inc.,Morgantown, WV 26505 U.S.A.For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).INSTRUCTIONS FOR USEClobetasol Propionate FoamImportant information: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth, or vagina; if contact happens, rinse well with water.How to apply clobetasol propionate foamFigure AStep 1: 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 Figure A).Figure BStep 2: Shake the can of clobetasol propionate foam before use. (See Figure B).Figure CStep 3: Turn the can of clobetasol propionate foam upside down and press the nozzle. See Figure C.Figure DStep 4: Press down on the actuator to dispense a small amount of clobetasol propionate foam into the palm of your hand. (See Figure D).Figure EStep 5: Apply a thin layer of clobetasol propionate foam to cover the affected area. Gently rub the foam into the affected area until the foam disappears. (See Figure E).Step 6: Wash your hands after applying clobetasol propionate foam. •Throw away any of the unused medicine that you dispensed out of the can.The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured for:Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.Manufactured by:DPT Laboratories, Ltd.San Antonio, TX 78215 U.S.A.140952-0518Revised: 5/2018DPT:ECLOBFOG:R2

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