Application Nr Approved Date Route Status External Links
NDA020670 1996-04-16 None OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredient Purpose Miconazole Nitrate (200 Mg In Each Vaginal Insert) Vaginal Antifungal Miconazole Nitrate 2% (external Cream) Vaginal Antifungal

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Cetyl Alcohol CETYL ALCOHOL Molecular
3. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
4. 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.
5. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Water WATER Molecular
8. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Miconazole Nitrate MICONAZOLE NITRATE ZINC607971

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