FDA label
What is ketoconazole used for?
The FDA-approved uses of ketoconazole, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic derm...”
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Ketoconazole, cream
Indications and Usage, quoted from the label by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC (ANDA076294). Cross-references to other label sections are left out.
Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Source: DailyMed label, set id cad7c647-34a9-4e4e-83b3-8d78e58f588f, version 8, effective January 28, 2026. NDC 0168-0099, one of 21 listings for this product.
Ketoconazole, shampoo, suspension
Indications and Usage, quoted from the label by Cosette Pharmaceuticals, Inc. (ANDA076942). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 2d7c8dd1-59b5-2645-e063-6394a90a5bda, version 1, effective February 6, 2025. NDC 0713-0592, one of 13 listings for this product.
Ketoconazole, tablet
Indications and Usage, quoted from the label by Strides Pharma Science Limited (ANDA210457). Cross-references to other label sections are left out.
Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
Source: DailyMed label, set id 6d4be760-c723-4f54-a854-12c61cf91703, version 8, effective December 17, 2025. NDC 64380-827, one of 12 listings for this product.
Questions
What is ketoconazole used for?
The FDA label says: “Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic derm...”
What drug class is ketoconazole?
FDA lists ketoconazole in the Azole Antifungal established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.