Application Nr Approved Date Route Status External Links
NDA021308 2001-06-29 None OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredients Purpose Miconazole Nitrate 1200 Mg (in Vaginal Insert) Vaginal Antifungal Miconazole Nitrate 2% (external Cream) Vaginal Antifungal

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Lecithin LECITHIN Unresolved
3. Mineral Oil MINERAL OIL Unresolved
4. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
5. Cetyl Alcohol CETYL ALCOHOL Molecular
6. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
7. 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.
8. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Water WATER Molecular
11. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

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

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