Application Nr Approved Date Route Status External Links
ANDA077092 2005-08-10 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ciclopirox Topical Suspension Usp Is Indicated For The Topical Treatment Of The Following Dermal Infections: Tinea Pedis, Tinea Cruris, And Tinea Corporis Due To Trichophyton Rubrum, Trichophyton Mentagrophytes, Epidermophyton Floccosum, And Microsporum Canis; Cutaneous Candidiasis (moniliasis) Due To Candida Albicans; And Tinea (pityriasis) Versicolor Due To Malassezia Furfur.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Coco Diethanolamide COCO DIETHANOLAMIDE Unresolved
2. Lactic Acid, Unspecified Form LACTIC ACID, UNSPECIFIED FORM Molecular
3. Mineral Oil MINERAL OIL Unresolved
4. Myristyl Alcohol MYRISTYL ALCOHOL Molecular
5. Octyldodecanol OCTYLDODECANOL Molecular
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. Water WATER Molecular
8. 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.
9. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ciclopirox Olamine CICLOPIROX OLAMINE ZINC8214617

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