Ketoconazole Cream
Drug Details
- Generic Name
- Ketoconazole Cream
- Brand Names
- Ketoconazole Cream
- Application Number
- ANDA212443
- Sponsor
- Direct_Rx
- NDC Codes
- 1
- Dosage Forms
- CREAM
- Routes
- TOPICAL
- Active Ingredients
- KETOCONAZOLE
Indications and Usage
INDICATIONS AND USAGE 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) ; and in the treatment of cutaneous candidiasis caused by Candida spp . and in the treatment of seborrheic dermatitis.
Warnings
WARNINGS Ketoconazole Cream, 2% is not for ophthalmic use. Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.