Application Nr Approved Date Route Status External Links
ANDA208136 2016-10-24 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Nystatin And Triamcinolone Acetonide Cream Is Indicated For The Treatment Of Cutaneous Candidiasis; It Has Been Demonstrated That The Nystatin-Steroid Combination Provides Greater Benefit Than The Nystatin Component Alone During The First Few Days Of Treatment.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
2. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
3. Polyoxyl 20 Cetostearyl Ether POLYOXYL 20 CETOSTEARYL ETHER Unresolved
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
6. Water WATER Molecular
7. Simethicone Emulsion SIMETHICONE EMULSION Unresolved
8. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
9. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Nystatin
2. Triamcinolone Acetonide

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