Application Nr Approved Date Route Status External Links
ANDA076419 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ketoconazole Shampoo, 2% Is Indicated For The Treatment Of Tinea (Pityriasis) Versicolor Caused By Or Presumed To Be Caused By Pityrosporum Orbiculare (Also Known As Malassezia Furfur Or M. Orbiculare ) . Note: Tinea (Pityriasis) Versicolor May Give Rise To Hyperpigmented Or Hypopigmented Patches On The Trunk Which May Extend To The Neck, Arms And Upper Thighs. Treatment Of The Infection May Not Immediately Result In Normalization Of Pigment To The Affected Sites. Normalization Of Pigment Following Successful Therapy Is Variable And May Take Months, Depending On Individual Skin Type And Incidental Sun Exposure. Although Tinea Versicolor Is Not Contagious, It May Recur Because The Organism That Causes The Disease Is Part Of The Normal Skin Flora.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ketoconazole KETOCONAZOLE ZINC643153

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