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Important Safety Information Regarding XOLEGEL® (ketoconazole) Gel, 2%
XOLEGEL® (ketoconazole) Gel, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. Safety and efficacy of XOLEGEL® Gel for the treatment of fungal infections have not been established. Avoid fire, flame, or smoking during and immediately following application of XOLEGEL® Gel. XOLEGEL® Gel is for topical use only, and not for ophthalmic, oral, or intravaginal use. XOLEGEL® Gel may be irritating to mucous membranes. Contact with eyes, nostrils, and mouth should be avoided. The most common treatment-related adverse event with XOLEGEL® Gel observed in clinical trials (incidence > 1%) was application site burning (4%). The incidence of all other treatment-related adverse events was < 1%. Hepatitis and, at high doses, lowered testosterone and ACTH-induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.