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Onexton Gel
  • Professionals
  • FDA PI

Onexton Gel

Generic name:clindamycin phosphate and benzoyl peroxid
Dosage form: gel
Drug class:Topical acne agents

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

Indications and Usage for Onexton Gel

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 and older.

Onexton Gel Dosage and Administration

Before applying Onexton Gel, wash the face gently with a mild soap, rinse with warm water, and pat the skin dry. Apply a pea-sized amount of Onexton Gel to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin.

Use of Onexton Gel beyond 12 weeks has not been evaluated.

Onexton Gel is not for oral, ophthalmic, or intravaginal use.

Dosage Forms and Strengths

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 in a white to off-white, opaque, smooth gel.

Contraindications

Hypersensitivity

Onexton Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with Onexton Gel [seePostmarketing Experience (6.2)].

Colitis/Enteritis

Onexton Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [seeWarnings and Precautions (5.1)].

Warnings and Precautions

Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin....