Drug Catalog - Product Detail
CLOBETASOL PROPIONATE CREAM USP 0.05% 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 71085-0007-60 | IPG PHARMACEUTICALS | 60 | 0.05% | NA |
PACKAGE FILES
Generic Name
CLOBETASOL PROPIONATE
Substance Name
CLOBETASOL PROPIONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA074249
Description
DESCRIPTION Clobetasol propionate cream contains the active compound clobetasol propionate, 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 a white to cream-colored crystalline powder insoluble in water. Chemically, it 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: C 25 H 32 CIFO 5 Molecular Weight: 467 Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol and white wax. Chemical Structure
How Supplied
HOW SUPPLIED Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes: 60 g (NDC 71085-007-60). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE
Indications & Usage
INDICATIONS AND USAGE Clobetasol propionate cream is a 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 per 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
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 a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per 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.