Clobetasol Propionate (emollient)

Clobetasol Propionate (emollient) is an FDA-registered drug product whose active ingredient is CLOBETASOL PROPIONATE. It is labelled by Bryant Ranch Prepack taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 72162-2628, application ANDA209411, label effective 20260423. It is one of 35 FDA drug label records sharing the active ingredient CLOBETASOL PROPIONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CLOBETASOL PROPIONATE are most often described in connection with: clobetasol propionate, cream usp, years age, corticosteroid-responsive dermatoses, moderate severe, plaque-type psoriasis, total dosage, exceed grams. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Clobetasol propionate cream USP, 0.05% (emollient) is a corticosteroid indicated for: The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1) The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2) Limitations of Use 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. (1.3) The total dosage should not exceed 50 grams per week. (1.3) Avoid use if skin atrophy is present at the treatment site. (1.3) Clobetasol propionate cream USP, 0.05% (emollient) is a super-high potency corticosteroid indicated for: 1.1 Corticosteroid-Responsive Dermatoses 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. 1.2 Moderate to Severe Plaque-Type Psoriasis 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. 1.3 Limitations of Use 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.

2 DOSAGE AND ADMINISTRATION 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. 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. 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. (2) Treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used. (2) 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 benefit of extending treatment should be weighed against the risk of HPA suppression. (2)

4 CONTRAINDICATIONS None None (4)

6 ADVERSE REACTIONS The most common adverse reaction is burning/stinging (incidence 5%); common adverse reactions (incidence < 2%) are pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia. (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact The J. Molner Company LLC at 1-800-552-8750 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 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.

FDA lists 35 drug label records with CLOBETASOL PROPIONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Clobetasol Propionate (emollient) used for?
1 INDICATIONS AND USAGE Clobetasol propionate cream USP, 0.05% (emollient) is a corticosteroid indicated for: The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1) The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2) Limitations of Use Clobetasol propionate …

Who makes Clobetasol Propionate (emollient)?
Bryant Ranch Prepack is the labeler of record for Clobetasol Propionate (emollient). 35 FDA label records share the active ingredient CLOBETASOL PROPIONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Clobetasol Propionate (emollient) come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Clobetasol Propionate (emollient) prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CLOBETASOL PROPIONATE?
Yes. 35 FDA drug label records list CLOBETASOL PROPIONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Clobetasol Propionate (emollient) been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.