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INDICATION

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.

Please click here for full Prescribing Information.

INDICATION

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.

Please click here for full Prescribing Information.