Application Nr Approved Date Route Status External Links
ANDA040879 2010-08-20 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 (10 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. Glyceryl Stearate Se GLYCERYL STEARATE SE Unresolved
3. Cholesterol CHOLESTEROL Molecular
4. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
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. Cetyl Alcohol CETYL ALCOHOL Molecular
7. 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.
8. Polyoxyl 40 Stearate POLYOXYL 40 STEARATE Unresolved
9. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
10. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydrocortisone HYDROCORTISONE ZINC13540519

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