Application Nr Approved Date Route Status External Links
ANDA075581 2000-04-25 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ketoconazole Cream, 2% Is Indicated For The Topical Treatment Of Tinea Corporis, Tinea Cruris And Tinea Pedis Caused By Trichophyton Rubrum, T. Mentagrophytes And Epidermophyton Floccosum; In The Treatment Of Tinea (pityriasis) Versicolor Caused By Malassezia Furfur (pityrosporum Orbiculare); And In The Treatment Of Cutaneous Candidiasis Caused By Candida Spp.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Water WATER Molecular
2. Cetyl Alcohol CETYL ALCOHOL Molecular
3. Stearyl Alcohol STEARYL ALCOHOL Molecular
4. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
5. Sorbitan Monostearate SORBITAN MONOSTEARATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , FEED-Feed additives FS-Substances permitted as optional ingredient in a standardized food.
6. 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.
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ketoconazole KETOCONAZOLE ZINC643153

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