INDICATION AND IMPORTANT SAFETY INFORMATION

ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

IMPORTANT SAFETY INFORMATION

ONEXTON Gel is contraindicated in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation, or lincomycin.
ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. ONEXTON Gel should be discontinued if significant diarrhea occurs.
Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death.
Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic reaction such as swelling and shortness of breath, they should be instructed to discontinue use and contact a physician immediately.
The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning and stinging.
ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component.
ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother.
Patients should be advised to avoid contact with the eyes or mucous membranes.
Patients should minimize exposure to natural and avoid artificial sunlight (tanning beds or UVA/B treatment) while using ONEXTON Gel. To minimize exposure to sunlight, protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used.

To report SUSPECTED ADVERSE REACTIONS contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

REFERENCE: 1. ONEXTON [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. 2. Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2014;13(9):1083-1089.