Application Nr Approved Date Route Status External Links
ANDA074249 1996-07-08 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clobetasol Propionate Gel, Cream And Ointment Are Super-High Potency Corticosteroid Formulations 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.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Water WATER Molecular
3. Chlorocresol CHLOROCRESOL Molecular
4. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
5. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
6. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
7. Stearyl Alcohol STEARYL ALCOHOL Molecular
8. Sorbitan Sesquioleate SORBITAN SESQUIOLEATE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clobetasol Propionate CLOBETASOL PROPIONATE ZINC3977767