Application Nr Approved Date Route Status External Links
ANDA085979 2001-12-20 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid-Responsive Dermatoses.

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Cetyl Alcohol CETYL ALCOHOL Molecular
2. Lanolin LANOLIN Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Hydrogenated Coconut Oil HYDROGENATED COCONUT OIL Unresolved
4. Sorbitan Sesquioleate SORBITAN SESQUIOLEATE Unresolved
5. Stearyl Alcohol STEARYL ALCOHOL Molecular
6. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Trolamine TROLAMINE Molecular
8. Polyoxyl 40 Stearate POLYOXYL 40 STEARATE Unresolved
9. Diisopropyl Adipate DIISOPROPYL ADIPATE Molecular
10. Povidones POVIDONES Unresolved
11. Dimethicone DIMETHICONE Molecular
12. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
13. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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