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.

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 30 gram and 60 gram tubes.

ZIANA Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.

ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:

Clindamycin phosphate:
Molecular Formula: C18H34ClN2O8PS      Molecular Weight: 504.97

The chemical name for tretinoin is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8 nonatetraenoic acid (all-trans form). The structural formula for tretinoin is represented below:

Tretinoin:

Molecular Formula: C20H28O2      Molecular Weight: 300.44

ZIANA Gel contains the following inactive ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP.

The safety and efficacy of once daily use of ZIANA Gel for treatment of acne vulgaris were assessed in three 12-week prospective, multi-center, randomized, blinded studies in patients 12 years and older. Studies 1 and 2 were of identical design, and compared ZIANA Gel to clindamycin in the vehicle gel, tretinoin in the vehicle gel, and the vehicle gel alone. Patients with mild, moderate, or severe acne were enrolled in the studies. The co-primary efficacy variables were:

1.

Mean percent change from baseline at Week 12 in

1.

inflammatory lesion counts,

2.

non-inflammatory lesion counts, and

3.

total lesion counts

2.

Percent of subjects who cleared or almost cleared at Week 12 as judged by an Evaluator's Global Severity (EGS) score.

The EGS scoring scale used in all of the clinical trials for ZIANA Gel is as follows:

In Study 1, a total of 1252 patients were enrolled, and in Study 2, a total of 1288 patients were enrolled. The combined results are presented in Table 3.

In Study 3, ZIANA Gel was compared to clindamycin gel in a total of 2010 patients with moderate or severe acne vulgaris (see Table 3). As with Studies 1 and 2, the co-primary endpoints were mean percent reduction in lesion counts (inflammatory, non-inflammatory and total) and the EGS score. In Study 3, success on the EGS score was assessed by the percentage of subjects who had at least 2 grades of improvement from Baseline to Week 12.

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

 

30 gram tube                      NDC 99207-300-30
60 gram tube                      NDC 99207-300-60

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada
U.S. Patent 6,387,383

Ziana is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9480201

20001130B

PATIENT INFORMATION
ZIANA® (ZEE-AH-NA)
(clindamycin phosphate 1.2% and tretinoin 0.025%) Gel

IMPORTANT: Not for mouth, eye, or vaginal use.

Read the Patient Information that comes with ZIANA Gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your acne or treatment.

What is ZIANA Gel?

ZIANA Gel is an antibiotic and retinoid combination medicine used for the skin treatment of acne in patients 12 years and older.

Who should not use ZIANA Gel?

Do not use ZIANA Gel if you:

•

have Crohn's Disease

•

have Ulcerative Colitis

•

have developed colitis with past antibiotic use

Tell your doctor:

•

if you are pregnant or planning to become pregnant. It is not known if ZIANA Gel may harm your unborn baby.

•

if you are breastfeeding. ZIANA Gel may pass through your milk and may harm your baby.

•

about all the medicines and skin products you use:

•

ZIANA Gel should not be used with erythromycin-containing products.

•

Avoid medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and skin products that contain alcohol, astringents, spices or lime. These products may cause increased skin irritation if used with ZIANA Gel.

How should I use ZIANA Gel?

Use ZIANA Gel exactly as prescribed. It may take some time for you to see improvement of your acne with ZIANA Gel. Your doctor will tell you how long to use ZIANA Gel.

At bedtime:

•

Wash your face gently with a mild soap and warm water.

•

Pat the skin dry.

•

Apply a pea-size amount of ZIANA Gel to your fingertip and spread it over your face. Gently, smooth it into your skin. Do not get ZIANA Gel in your eyes or mouth, on your lips, on the corners of your nose, or on open wounds.

In the morning:

•

Apply a sunscreen and reapply during the day as needed.

•

Do not apply ZIANA Gel more than once a day.

•

Do not use too much ZIANA Gel. Too much ZIANA Gel may irritate your skin.

•

Do not wash your face more than 2 to 3 times a day. Washing your face too often or scrubbing it may make your acne worse.

Avoid:

•

excessive exposure to the sun, cold, and wind. Weather extremes can dry and burn the skin. Always use a sunscreen on ZIANA Gel treated skin, even on cloudy days. Use other protective clothing such as a hat when you are in the sun.

•

the use of sunlamps and tanning booths.

If your face becomes sunburned, stop ZIANA Gel until your skin has healed.

What are possible side effects with ZIANA Gel?

•

Skin irritation. ZIANA Gel may cause skin irritation such as dryness, redness, peeling, burning, or stinging. Stop ZIANA Gel and call your doctor if your skin becomes very red, swollen, blistered, or crusted.

•

Change in skin color. ZIANA Gel may cause a temporary skin color change (lighter or darker).

•

Colitis. This occurs rarely. Stop ZIANA Gel and call your doctor if you develop severe watery diarrhea, or bloody diarrhea.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with ZIANA Gel. Ask your doctor or pharmacist for more information.

How should I store ZIANA Gel?

•

Store ZIANA Gel at room temperature, 59° to 86°F (15° to 30°C). Do not freeze.

•

Keep ZIANA Gel away from heat and light.

•

Keep the tube tightly closed.

•

Keep ZIANA Gel and all medicines out of reach of children.

General information about ZIANA Gel

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use ZIANA Gel for a condition for which it was not prescribed. Do not give ZIANA Gel to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about ZIANA Gel. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about ZIANA Gel that is written for healthcare professionals.

If you have questions about ZIANA Gel you can also call: 1-800-321-4576 (this is a toll-free number) between 10:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday.

What are the ingredients in ZIANA Gel?

Active Ingredients: clindamycin phosphate 1.2% and tretinoin 0.025%

Inactive Ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP.

Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada

U.S. Patent 6,387,383

Ziana is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9480201
20001130B

Revised: 03/2017

PRINCIPAL DISPLAY PANEL - 30 g Carton

NDC 99207-300-30

ZIANA®
(clindamycin phosphate 1.2%
and tretinoin 0.025%) Gel

 

Rx only

Net Wt. 30 g

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL,
OR INTRAVAGINAL USE