XOLEGEL® (ketaconazole) Gel, 2%, is an azole antifungal indicated for 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.
Click here for Full Prescribing Information for XOLEGEL® Gel.Important Safety Information Regarding XOLEGEL® (ketoconazole) Gel, 2%
- XOLEGEL® Gel is for topical use only.
- XOLEGEL® Gel is flammable. Avoid using near fire, flame, or smoking during and immediately following application of XOLEGEL® Gel.
- XOLEGEL® Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- It is not known whether XOLEGEL® Gel is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XOLEGEL® Gel is administered to a nursing woman.
- Safety and efficacy of XOLEGEL® Gel in children below the age of 12 have not been established.
- The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in less than 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Adverse events identified during post approval use with XOLEGEL® Gel include burning sensation, pain, skin irritation, and erythema.
Click here for Full Prescribing Information for XOLEGEL® Gel.
To report SUSPECTED ADVERSE REACTIONS, contact Aqua Pharmaceuticals at 1-866-665-2782, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.