Clindagel (Clindamycin Phosphate Topical Gel) - Indications and Dosage

INDICATIONS AND USAGE

Clindagel^® is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.)

DOSAGE AND ADMINISTRATION

Apply a thin film of Clindagel^® once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly.

Keep container tightly closed.

HOW SUPPLIED

Clindagel^® containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following sizes:

75 mL bottle - NDC 0299-4500-75

40 mL bottle - NDC 0299-4500-40

Store under controlled room temperature 20°C-25°C (68°F to 77°F); excursions permitted between 15°C-30°C (59°F to 86°F). Do not store in direct sunlight.

Marketed by:

Galderma Laboratories, L.P.

Fort Worth, Texas 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

www.clindagel.com

325053-0603    Revised: June 2003