clindamycin and benzoyl peroxide

INDICATIONS AND USAGE Clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION Clindamycin and benzoyl peroxide topical gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

CONTRAINDICATIONS Clindamycin and benzoyl peroxide topical gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide topical gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide topical gel, 1%/5% and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and benzoyl peroxide topical gel, 1%/5% n=420 Vehicle n=168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 8 (2%) 1 (<1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (<1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

DESCRIPTION Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). 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. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide. Clindamycin Chemical Structure Benzoyl Peroxide Chemical Structure

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS Size (Net Weight) NDC Benzoyl Peroxide Gel Clindamycin Phosphate Solution (In plastic bottle) 25 grams 21922-068-43 20 grams 5 grams 35 grams (pump) 21922-068-44 28 grams 7 grams 50 grams 21922-068-45 40 grams 10 grams 50 grams (pump) 21922-068-46 40 grams 10 grams Prior to dispensing, add the solution in the bottle to the gel and stir until homogenous in appearance (1 to 11⁄2 minutes). For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing. Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children. Call your doctor for medical advice about side effects. You may report side effects to Encube Ethicals Pvt. Ltd. 1-833-285-4151 or FDA at 1-800-FDA-108 Prescribing Information as of July 2017. Rx Only Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev.: 06/2023