Application Nr Approved Date Route Status External Links
NDA019356 1990-06-18 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Naftin® Cream, 1% Is Indicated For The Topical Treatment Of Tinea Pedis, Tinea Cruris, And Tinea Corporis Caused By The Organisms Trichophyton Rubrum, Trichophyton Mentagrophytes, And Epidermophyton Floccosum. Naftin® Gel, 1% Is Indicated For The Topical Treatment Of Tinea Pedis, Tinea Cruris, And Tinea Corporis Caused By The Organisms Trichophyton Rubrum, Trichophyton Mentagrophytes, Trichophyton Tonsuransefficacy For This Organism In This Organ System Was Studied In Fewer Than 10 Infections. , Epidermophyton Floccosum .

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Cetyl Alcohol CETYL ALCOHOL Molecular
2. Cetyl Esters Wax CETYL ESTERS WAX Molecular
3. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
4. 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.
5. Water WATER Molecular
6. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Naftifine Hydrochloride NAFTIFINE HYDROCHLORIDE ZINC1530977

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