How Supplied:
2% gel, 15 g
Indications and Usage:
XOLEGEL® Gel 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 treatment of fungal infection have not been established.
Prescribing Instructions:
Prescribing Information Instructions [PDF]
Side Effects and Contraindications:
The most common treatment-related adverse events to Xolegel Gel observed in clinical trials (incidence >1%) were application site burning (4.2%) and headache (1.1%). Xolegel Gel is contraindicated in those patients with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity is noted. 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 treatment of fungal infections have not been established. Xolegel Gel is contraindicated in those patients with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity is noted. 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 events to Xolegel Gel observed in clinical trials (incidence >1%) were application site burning (4.2%) and headache (1.1%). 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.
Company:
Aqua Pharmaceuticals
610-644-7000
aquapharm.com
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