Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%

Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% is an FDA-registered drug product whose active ingredient is CLOBETASOL PROPIONATE CREAM USP, 0.05%. It is labelled by REMEDYREPACK INC. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 70518-4374, application ANDA212982, label effective 20260909. It is one of 4 FDA drug label records sharing the active ingredient CLOBETASOL PROPIONATE CREAM USP, 0.05%. 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 CREAM USP, 0.05% are most often described in connection with: usage clobetasol, propionate cream, usp super-high, potency corticosteroid, formulation indicated, pruritic manifestations, corticosteroid-responsive dermatoses, treatment beyond. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

DOSAGE AND ADMINISTRATION: Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely (See INDICATIONS AND USAGE). Clobetasol propionate cream is super- high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used . As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate cream should not be used with occlusive dressings. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

CONTRAINDICATIONS: Clobetasol propionate cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

ADVERSE REACTIONS: In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 4 drug label records with CLOBETASOL PROPIONATE CREAM USP, 0.05% 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 Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% used for?
INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the …

Who makes Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%?
REMEDYREPACK INC. is the labeler of record for Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%. 4 FDA label records share the active ingredient CLOBETASOL PROPIONATE CREAM USP, 0.05%, 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 Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% 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 Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% 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 CREAM USP, 0.05%?
Yes. 4 FDA drug label records list CLOBETASOL PROPIONATE CREAM USP, 0.05% 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 Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% 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.