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 Ingredients Purpose Miconazole Nitrate (200 Mg In Each Suppository) Vaginal Antifungal Miconazole Nitrate 2% (external Cream) Vaginal Antifungal

All Formulated Excipients (7 Total)

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

Active Ingredients ( 1 Total)

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

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