ONEXTON Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. (1)

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Apply a pea-sized amount of ONEXTON Gel to the face once daily. ( 2)

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Not for oral, ophthalmic, or intravaginal use. ( 2)

Gel, 1.2%/3.75%

Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide. (3)

ONEXTON Gel is contraindicated in:

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Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4.1)

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Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4.2)

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Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. ONEXTON Gel should be discontinued if significant diarrhea occurs. ( 5.1)

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Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. ( 5.2)

The most common adverse reactions are: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.1)