Ziana Gel

Indications
Dosage
How Supplied

INDICATIONS

ZIANA Gel (clindamycin phosphate, tretinoin) is indicated for the topical treatment of acne vulgaris in patients 12 years or 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

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.
Skin Irritation

ZIANA Gel (clindamycin phosphate, tretinoin) may cause irritation such as erythema, scaling, itching, burning, or stinging.

Colitis

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
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Ziana Gel - User Reviews

Ziana Gel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ziana Gel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.