Important Safety Information

Xolegel^® Gel is a prescription medicine used on the skin (topical) to treat a condition called seborrheic dermatitis. Patients with seborrheic dermatitis can have areas of dry, flaky skin (scales) on the scalp, face, ears, chest or upper back.

Xolegel Gel has not been studied in children below the age of 12.

Important Safety Information. The safety and effectiveness of Xolegel Gel for treatment of fungal infections has not been established. Xolegel Gel is not recommended for those with a history of sensitivity reactions to any of its ingredients. If irritation occurs or worsens, stop treatment and talk to your dermatologist. Xolegel Gel is for topical use only, and not for use in your eyes, mouth or vagina. Because Xolegel Gel may be irritating to mucous membranes, avoid contact with your eyes, nostrils and mouth. Formal drug interaction studies with Xolegel Gel have not been performed. The most common treatment-related adverse side effects were burning where applied and headache. Xolegel Gel, a topical ketoconazole, has not produced side effects like those seen with the use of oral ketoconazole, such as hepatitis, lowered testosterone and ACTH-induced corticosteroid serum levels. Avoid fire, flame, or smoking during and immediately following application of Xolegel Gel.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.