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Ketoconazole Foam

FDA Drug Profile — Ketoconazole

Drug Details

Generic Name
Ketoconazole Foam
Brand Names
Ketoconazole
Application Number
ANDA213601
Sponsor
Xiromed, LLC
NDC Codes
1
Dosage Forms
AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients
KETOCONAZOLE

Indications and Usage

1 INDICATIONS AND USAGE Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established. Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older ( 1 ). Limitations of Use Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.