Application Nr Approved Date Route Status External Links
ANDA205076 2016-03-07 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Oxiconazole Nitrate Cream Is Indicated For The Topical Treatment Of The Following Dermal Infections: Tinea Pedis, Tinea Cruris, And Tinea Corporis Due To Trichophyton Rubrum, Trichophyton Mentagrophytes, Or Epidermophyton Floccosum. Oxiconazole Nitrate Cream Is Indicated For The Topical Treatment Of Tinea (pityriasis) Versicolor Due To Malassezia Furfur (see Dosage And Administration And Clinical Studies). Oxiconazole Nitrate Cream May Be Used In Pediatric Patients For Tinea Corporis, Tinea Cruris, Tinea Pedis, And Tinea (pityriasis) Versicolor; However, These Indications For Which Oxiconazole Nitrate Cream Has Been Shown To Be Effective Rarely Occur In Children Below The Age Of 12.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Chloroform CHLOROFORM Molecular
2. 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.
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Water WATER Molecular
5. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oxiconazole Nitrate OXICONAZOLE NITRATE ZINC3873295

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