Label: ONEXTON- clindamycin phosphate and benzoyl peroxide gel

  • NDC Code(s): 0187-3050-35, 0187-3050-50
  • Packager: Bausch Health US, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 6, 2020

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel.   ONEXTON® (clindamycin phosphate and ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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.
  • 2 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 ...
  • 3 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 ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Colitis - Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have ...
  • 6 ADVERSE REACTIONS
    The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: • Colitis [see Warnings and Precautions (5.1)]. 6.1 Clinical Trials ...
  • 7 DRUG INTERACTIONS
    7.1 Erythromycin - Avoid using ONEXTON Gel in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no available data on ONEXTON Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or ...
  • 11 DESCRIPTION
    ONEXTON Gel is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Clindamycin: Clindamycin is a lincosamide antibacterial [see Microbiology (12.4)]. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity, mutagenicity, and impairment of fertility testing of ONEXTON Gel have not been performed. Benzoyl peroxide has been ...
  • 14 CLINICAL STUDIES
    The safety and efficacy of once-daily use of ONEXTON Gel was assessed in a 12-week multi-center, randomized, blinded trial in subjects 12 years and older with moderate to severe acne vulgaris ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - ONEXTON Gel, 1.2%/3.75% is a white to off-white smooth gel supplied as: NDC 0187-3050-50 50 g pump - 16.2 Dispensing Instructions for the ...
  • 17PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). • Patients who develop allergic reactions, such as severe swelling or shortness of breath, should discontinue ...
  • PATIENT INFORMATION
    ONEXTON® (ON-EX-TUN) (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75% Important information: ONEXTON Gel is for use on skin only (topical use). Do not use ONEXTON Gel in your mouth ...
  • INSTRUCTIONS FOR USE
    ONEXTON® (ON-EX-TUN) (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75% Important Information: ONEXTON Gel is for use on skin only (topical use). ONEXTON Gel is not for use in your ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 50 gram Carton - NDC 0187-3050-50 - Rx only - ONEXTON® (Clindamycin Phosphate and - Benzoyl Peroxide) Gel, 1.2%/3.75% For Topical Use Only - Not for ophthalmic, oral or ...
  • INGREDIENTS AND APPEARANCE
    Product Information