Application Nr Approved Date Route Status External Links
ANDA206960 2017-04-10 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Naftifine Hydrochloride Cream Usp, 2% Is Indicated For The Treatment Of Interdigital Tinea Pedis, Tinea Cruris, And Tinea Corporis Caused By The Organism Trichophyton Rubrum. Naftifine Hydrochloride Cream Usp, 2% Is An Allylamine Antifungal Indicated For The Treatment Of Interdigital Tinea Pedis, Tinea Cruris, And Tinea Corporis Caused By The Organism Trichophyton Rubrum. (1)

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Benzyl Alcohol BENZYL ALCOHOL Molecular
2. Cetyl Alcohol CETYL ALCOHOL Molecular
3. Cetyl Esters Wax CETYL ESTERS WAX Molecular
4. Isopropyl Myristate ISOPROPYL MYRISTATE 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. 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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