Indication

ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older.

Do not get ONEXTON Gel in your mouth, eyes, or vagina, or on your lips. It is not known whether ONEXTON Gel is safe and effective for use longer than 12 weeks, or in children under 12 years of age.

Important Safety Information

Do not use ONEXTON Gel if you have: Crohn's disease, ulcerative colitis, had inflammation of the colon (colitis) or severe diarrhea with past antibiotic use. Talk with your doctor if you are not sure if you have one of these conditions.

ONEXTON Gel can cause serious side effects including:

Inflammation of the colon (colitis). Stop using ONEXTON Gel and call your doctor right away if you have severe watery diarrhea, or bloody diarrhea.
Allergic reactions. Stop using ONEXTON Gel, call your doctor and get help right away if you have any of the following symptoms: severe itching; swelling of your face, eyes, lips, tongue or throat; or trouble breathing.

Common side effects with ONEXTON Gel include skin irritation. Stop using ONEXTON Gel and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Talk to your doctor about any side effect that bothers you or that does not go away.

Tell your doctor about all the medicines and skin products you use. Especially tell your doctor if you will have surgery with general anesthesia. One of the medicines in ONEXTON Gel (clindamycin) can affect how certain medicines work when used in general anesthesia.

ONEXTON Gel should not be used with products that contain erythromycin.
Other skin and topical acne products may increase the irritation of your skin when used with ONEXTON Gel.

Pregnancy and Nursing Mothers: It is not known whether ONEXTON Gel will harm your unborn baby or nursing infant, so talk to your doctor if you are pregnant. If you are nursing, you and your doctor should decide if you will use ONEXTON Gel while breastfeeding.

Sun Protection: When using ONEXTON Gel, limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher.

You are encouraged to report negative side effects of prescription drugs.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please visit ONEXTON.com for more information, including Patient Information.

^®/TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product or brand names and logos are the property of their respective owners.