Application Nr Approved Date Route Status External Links
ANDA074221 1995-03-31 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clobetasol Propionate 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/week Because Of The Potential For The Drug To Suppress The Hypothalamicpituitary- 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 (11 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Glycol Stearate GLYCOL STEARATE Molecular
3. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
4. Peg-8 Stearate PEG-8 STEARATE Unresolved
5. Polysorbate 60 POLYSORBATE 60 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , FEED-Feed additives , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
8. Water WATER Molecular
9. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
10. Stearyl Alcohol STEARYL ALCOHOL Molecular
11. Sorbitan Sesquioleate SORBITAN SESQUIOLEATE Unresolved

Active Ingredients ( 1 Total)

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

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