Application Nr Approved Date Route Status External Links
ANDA072488 1989-02-06 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Cetyl Alcohol CETYL ALCOHOL Molecular
2. Mineral Oil MINERAL OIL Unresolved
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Sorbitan Monostearate SORBITAN MONOSTEARATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , FEED-Feed additives FS-Substances permitted as optional ingredient in a standardized food.
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. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved
7. Edetate Disodium EDETATE DISODIUM Molecular
8. Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) Unresolved
9. Castor Oil CASTOR OIL Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluocinonide FLUOCINONIDE ZINC3977978

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