Xolegel (Ketoconazole Topical) - Indications and Dosage

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 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)
45-gram aluminum tube (NDC 13478-003-05)

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

US Patent Numbers: 7,179,475 and application 10/722,134 (Patent Pending)

August 2008

XO-005