Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Important Safety Information
- Clindamycin Phosphate and Benzoyl Peroxide is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin, and also 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.
- Minimize sun exposure including use of tanning beds or sun lamps following drug application.
- The product should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component.
- Clindamycin Phosphate and Benzoyl Peroxide Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel in pediatric patients under the age of 12 have not been evaluated.
- The following adverse reactions were reported in some patients after administration of Clindamycin Phosphate and Benzoyl Peroxide Gel: erythema, scaling, itching, burning and stinging.
For additional safety and other information, including Patient Information, please see Full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.