Xolegel
INDICATIONS
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 infections have not been established.
DOSAGE AND ADMINISTRATION
XOLEGEL Gel should be applied once daily to the affected area for 2 weeks.
HOW SUPPLIED
XOLEGEL (ketoconazole, USP) Gel, 2% is supplied in the following size tubes:
2-gram sample tube (NDC 13478-003-02)
15-gram aluminum tube (NDC 13478-003-01)
STORAGE CONDITIONS
Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F)
Keep out of reach of children.
MANUFACTURED BY: DPT Laboratories, Ltd. 307 E. Josephine Street San Antonio, TX 78215, FOR: Barrier Therapeutics, Inc. 600 College Road East Princeton, NJ 08540-6697 www.barriertherapeutics.com 1-866-440-5508. July 2006. FDA rev date: 7/28/2006
Generic Name: Ketoconazole
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Xolegel
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