Application Nr Approved Date Route Status External Links
ANDA065315 2006-05-31 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Nystatin Cream Is Indicated In The Treatment Of Cutaneous Or Mucocutaneous Mycotic Infections Caused By Candida Albicans And Other Susceptible Candida Species. This Cream Is Not Indicated For Systemic, Oral, Intravaginal Or Ophthalmic Use.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
2. Polyoxyl 40 Stearate POLYOXYL 40 STEARATE Unresolved
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Water WATER Molecular
5. Simethicone SIMETHICONE Unresolved
6. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
7. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nystatin

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