Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes.

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is not for oral, ophthalmic, or intravaginal use.

Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 0.25 mg (0.025%) tretinoin in an aqueous-based gel. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is available in 30 gram and 60 gram tubes.

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.

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

Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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

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inflammatory lesion counts,

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non-inflammatory lesion counts, and

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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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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, Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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.

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is supplied as follows:
        30 gram tube                      NDC 68682-300-30
        60 gram tube                      NDC 68682-300-60

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

Instructions for Use

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At bedtime, the face should be gently washed with a mild soap and warm water. After patting the skin dry, apply Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel as a thin layer over the entire face (excluding the eyes and lips).

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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.

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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

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may cause irritation such as erythema, scaling, itching, burning, or stinging.

Colitis

In the event a patient treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel experiences severe diarrhea or gastrointestinal discomfort, Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be discontinued and a physician should be contacted.

Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
© 2020 Bausch Health Companies Inc. or its affiliates

9704800

PATIENT INFORMATION
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel

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

Read the Patient Information that comes with Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel?

Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel?

Do not use Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel if you:

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have Crohn’s Disease

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have Ulcerative Colitis

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have developed colitis with past antibiotic use

Tell your doctor:

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if you are pregnant or planning to become pregnant. It is not known if Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may harm your unborn baby.

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if you are breastfeeding. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may pass through your milk and may harm your baby.

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about all the medicines and skin products you use:

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Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should not be used with erythromycin-containing products.

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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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel.

How should I use Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel?

Use Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel exactly as prescribed. It may take some time for you to see improvement of your acne with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. Your doctor will tell you how long to use Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel.

At bedtime:

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

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Pat the skin dry.

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Apply a pea-size amount of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to your fingertip and spread it over your face. Gently, smooth it into your skin. Do not get Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in your eyes or mouth, on your lips, on the corners of your nose, or on open wounds.

In the morning:

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Apply a sunscreen and reapply during the day as needed.

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Do not apply Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel more than once a day.

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Do not use too much Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. Too much Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may irritate your skin.

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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:

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excessive exposure to the sun, cold, and wind. Weather extremes can dry and burn the skin. Always use a sunscreen on Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel treated skin, even on cloudy days. Use other protective clothing such as a hat when you are in the sun.

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the use of sunlamps and tanning booths.

If your face becomes sunburned, stop Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel until your skin has healed.

What are possible side effects with Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel?

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Skin irritation. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may cause skin irritation such as dryness, redness, peeling, burning, or stinging. Stop Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel and call your doctor if your skin becomes very red, swollen, blistered, or crusted.

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Change in skin color. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may cause a temporary skin color change (lighter or darker).

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Colitis. This occurs rarely.Stop Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. Ask your doctor or pharmacist for more information.

How should I store Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel?

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Store Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel at room temperature, 59° to 86°F (15° to 30°C). Do not freeze.

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Keep Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel away from heat and light.

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Keep the tube tightly closed.

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Keep Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel and all medicines out of reach of children.

General information about Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for a condition for which it was not prescribed. Do not give Clindamycin Phosphate 1.2% and Tretinoin 0.025%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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel that is written for healthcare professionals.

If you have questions about Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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.

Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada

© 2020 Bausch Health Companies Inc. or its affiliates

9704800
Revised: 04/2020

PRINCIPAL DISPLAY PANEL - 60 g Carton

NDC 68682-300-60

Rx only

CLINDAMYCIN PHOSPHATE 1.2%
and TRETINOIN 0.025% GEL

For Topical Use Only
Not For Ophthalmic, Oral, Or Intravaginal Use

Net Wt. 60 g

OCEANSIDE
PHARMACEUTICALS