Application Nr Approved Date Route Status External Links
NDA018737 1989-02-28 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Exelderm (sulconazole Nitrate, Usp) Cream, 1.0% Is An Antifungal Agent Indicated For The Treatment Of Tinea Pedis (athlete’s Foot), Tinea Cruris, And Tinea Corporis Caused By Trichophyton Rubrum, Trichophyton Mentagrophytes, Epidermophyton Floccosum, And Microsporum Canis,* And For The Treatment Of Tinea Versicolor.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Acetone ACETONE Molecular SOLV-Solvent REG-Food additives for which a petition has been filed and a regulation issued.
2. Stearyl Alcohol STEARYL ALCOHOL Molecular
3. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
4. Cetyl Alcohol CETYL ALCOHOL Molecular
5. 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.
6. 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.
7. Ascorbyl Palmitate ASCORBYL PALMITATE Molecular GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sulconazole Nitrate SULCONAZOLE NITRATE ZINC601250

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