"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
DOSAGE AND ADMINISTRATION
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 (clindamycin phosphate, tretinoin) should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. ZIANA Gel (clindamycin phosphate, tretinoin) is not for oral, ophthalmic, or intravaginal use.
DOSAGE FORMS AND STRENGTHS
ZIANA Gel (clindamycin phosphate, tretinoin) , 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 (clindamycin phosphate, tretinoin) contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 0.25 mg (0.025%) tretinoin in an aqueous based gel.
ZIANA Gel (clindamycin phosphate, tretinoin) 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:
|2 gram tube||NDC 99207-300-02|
|30 gram tube||NDC 99207-300-30|
|60 gram tube||NDC 99207-300-60|
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 (clindamycin phosphate, tretinoin) 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.
In the event a patient treated with ZIANA Gel (clindamycin phosphate, tretinoin) experiences severe diarrhea or gastrointestinal discomfort, ZIANA Gel (clindamycin phosphate, tretinoin) 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
Last reviewed on RxList: 3/22/2007
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