Application Nr Approved Date Route Status External Links
ANDA076357 2004-03-30 None OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Vaginal Antifungal

All Formulated Excipients (10 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. Butylated Hydroxyanisole BUTYLATED HYDROXYANISOLE Molecular
8. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
9. Mineral Oil MINERAL OIL Unresolved
10. Pegoxol 7 Stearate PEGOXOL 7 STEARATE Unresolved

Active Ingredients ( 1 Total)

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

Comments