Clobetasol Propionate .5 mg/g Aerosol, Foam
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Clobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- Clobetasol is a very strong prescription steroid cream (or foam, spray, shampoo, solution, or eye drop) used to calm inflamed, itchy skin. Depending on the specific product, it tre...
- That's a really important question. Most clobetasol skin products should be used for no more than 2 consecutive weeks. Some formulations can be extended to 4 weeks for certain case...
- How long can I use this? I've heard you can't use steroids for too long.
- Do not apply clobetasol to your face, underarms, or groin unless your doctor has specifically told you to — those areas absorb much more of the medication. Also avoid any skin that...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.5620 | $28.10 / 50 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clobetasol Propionate .5 mg/g 62332-0707-31 | Alembic | 1 can | $0.297 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 45802-0437-32 | Padagis | 1 can | $0.376 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-4193-03 | Sun | 1 can | $0.376 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 68462-0608-27 | Glenmark | 50 g | $0.376 | AB1 | Availability likely | — |
| Tovet (emollient formulation) .5 mg/g 43538-0952-10 | Medimetriks | 1 canister | $1.856 | AB2 | Availability likely | — |
| clobetasol propionate emollient formulation .5 mg/g 45802-0637-32 | Padagis | 1 can | $2.255 | AB2 | Availability likely | — |
| clobetasol propionate .5 mg/g 68462-0625-27 | Glenmark | 50 g | $2.255 | AB2 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 46708-0707-31 | Alembic | 1 can | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/gthis 63629-9460-01 | Bryant | 1 can | — | AB1 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-9460-01 You're viewing this | 1 CAN in 1 CARTON (63629-9460-1) / 50 g in 1 CAN | 2022-10-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Clobetasol Propionate Foam, 0.05% 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. Clobetasol Propionate Foam, 0.05% 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol Propionate Foam, 0.05% to the affected skin areas twice daily. Clobetasol Propionate Foam, 0.05% 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. Clobetasol Propionate Foam, 0.05% should not be used with occlusive dressings unless directed by a physician. Clobetasol Propionate Foam, 0.05% is for topical use only.
It is not for oral, ophthalmic, or intravaginal use. 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. • Apply a thin layer to the affected skin areas twice daily. (2) • Limit treatment to 2 consecutive weeks. (2) • Do not use more than 50 grams per week or more than 21 capfuls per week.
(2) • Discontinue therapy when control is achieved. (2) • Do not use with occlusive dressings unless directed by physician. (2) • Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
(2)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. • Foam, 0.05% (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. • None (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Clobetasol Propionate Foam, 0.05% can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop.
(5.1, 8.4) • Clobetasol Propionate Foam, 0.05% may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.2) • Clobetasol Propionate Foam, 0.05% is flammable.
Avoid fire, flame, or smoking during and immediately following application. (5.4)
5.1Effects on Endocrine System Clobetasol Propionate Foam, 0.05% 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, 0.05% on the HPA axis, 13 subjects applied clobetasol propionate foam, 0.05% 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) ].
5.2Ophthalmic Adverse Reactions Use of topical corticosteroids, including Clobetasol Propionate Foam, 0.05%, 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, 0.05% with eyes.
Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
5.3Allergic Contact Dermatitis 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.
5.4Flammable Contents Clobetasol Propionate Foam, 0.05% is flammable. Avoid fire, flame, or smoking during and immediately following application.
🤒 Adverse Reactions ▾
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 (5.2)] Most common adverse reactions (≥ 4%) are application site burning and other application site reactions. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 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, 0.05%. In 2 controlled clinical trials with clobetasol propionate foam, 0.05% in 360 subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the subjects treated with clobetasol propionate foam, 0.05% 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%).
6.2Postmarketing Experience 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 malaria. Ophthalmic adverse reactions may include: cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on Clobetasol Propionate Foam, 0.05% use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birth weight 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, 0.05% 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, 1.49–40.11)]. 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, 12–170g]) 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.
8.2Lactation 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, 0.05% and any potential adverse effects on the breastfed infant from Clobetasol Propionate Foam, 0.05% or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Clobetasol Propionate Foam, 0.05% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Clobetasol Propionate Foam, 0.05% directly to the nipple and areola to avoid direct infant exposure.
8.4Pediatric Use Safety and effectiveness of clobetasol propionate foam, 0.05% in patients younger than 12 years of age have not been established; therefore, use in children younger than 1…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on Clobetasol Propionate Foam, 0.05% use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birth weight 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, 0.05% 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, 1.49–40.11)]. 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, 12–170g]) 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of clobetasol propionate foam, 0.05% 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, 0.05% in the treatment of diaper dermatitis.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of clobetasol propionate foam, 0.05% 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics 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, 0.05% 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, 0.05% (See Table 1 below).
Table 1: Subjects With Reversible HPA Axis Suppression at Any Time During Treatment Dermatosis Clobetasol Propionate Foam, 0.05% Psoriasis 1 of 9 Atopic Dermatitis a 4 of 4 a Clobetasol propionate foam, 0.05% is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of clobetasol propionate foam, 0.05% in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white aerosol foam is available as follows: 50 g aluminum can NDC 63629-9460-01 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.
Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Clobetasol Propionate Foam, 0.05%, is a 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. Clobetasol propionate is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3, 20-dione 17-propionate, with the empirical formula C 25 H 32 CIFO 5 , a molecular weight of 466.97.
The following is the chemical structure: Clobetasol propionate is a white or almost white crystalline powder, practically insoluble in water. Each gram of Clobetasol Propionate Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, ethanol (60%), polysorbate 60, propylene glycol, purified water and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Effects on Endocrine System Clobetasol Propionate Foam, 0.05% may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including Clobetasol Propionate Foam, 0.05%, 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, 0.05% if surgery is contemplated [see Warnings and Precautions (5.1)]. Ophthalmic Adverse Reactions Advise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.2)] .
Local Adverse Reactions 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 Advise pregnant women of the potential risk to a fetus and to use Clobetasol Propionate Foam, 0.05% on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)] .
Lactation Advise a woman to use Clobetasol Propionate Foam, 0.05% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Clobetasol Propionate Foam, 0.05% directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)]. Important Administration Instructions Inform patients of the following: • Avoid use of Clobetasol Propionate Foam, 0.05% 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, 0.05% per week, or more than 21 capfuls per week. • Avoid use of Clobetasol Propionate Foam, 0.05% 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.