ketoconazole

FDA Drug Profile — ketoconazole, KETOCONAZOLE, Ketodan

Drug Details

Generic Name
ketoconazole
Brand Names
ketoconazole, KETOCONAZOLE, Ketodan
Application Number
ANDA091550
Sponsor
Bryant Ranch Prepack
NDC Codes
11
Dosage Forms
AEROSOL, FOAM, TABLET, CREAM
Routes
TOPICAL, ORAL
Active Ingredients
KETOCONAZOLE

Indications and Usage

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.