ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. ZIANA Gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. ZIANA Gel is not for oral, ophthalmic, or intravaginal use.

DOSAGE FORMS AND STRENGTHS

ZIANA Gel, a combination of a lincosamide antibiotic and a retinoid, contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a topical gel. Each gram of ZIANA Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 0.25 mg (0.025%) tretinoin in an aqueous based gel.

ZIANA Gel is available in 2 gram, 30 gram, and 60 gram tubes.

HOW SUPPLIED/STORAGE AND HANDLING

ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is supplied as follows:

Storage and Handling

• Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
• Protect from light.
• Protect from freezing.
• Keep out of the reach of children.
• Keep away from heat.
• Keep tube tightly closed.

PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling.

Instructions for Use

• At bedtime, the face should be gently washed with a mild soap and warm water. After patting the skin dry, apply ZIANA Gel as a thin layer over the entire face (excluding the eyes and lips).
• Patients should be advised not to use more than the recommended pea sized amount and not to apply more often than once daily (at bedtime) as this will not make for faster results and may increase irritation.
• A sunscreen should be applied every morning and reapplied over the course of the day as needed. Patients should be advised to avoid exposure to sunlight, sunlamp, ultraviolet light, and other medicines that may increase sensitivity to sunlight.

Skin Irritation

ZIANA Gel may cause irritation such as erythema, scaling, itching, burning, or stinging.

Colitis

In the event a patient treated with ZIANA Gel experiences severe diarrhea or gastrointestinal discomfort, ZIANA Gel should be discontinued and a physician should be contacted.

Manufactured for: Medicis, The Dermatology Company®
Scottsdale, AZ 85258
By: Contract Pharmaceuticals Limited Niagara
Buffalo, NY 14213
U.S. Patent 5,721,275
U.S. Patent 6,387,383
FDA rev date: 11/7/2006

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