Label: HUMANE ACNE WASH- benzoly peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 8, 2017

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  • Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 10%

    Purpose

    Acne Treatment

  • use

    for the treatment of acne.

  • Warnings

    For external use only.

    Do not use

    • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.
    • Using other topical acne drugs at the same time or right after use of the product may increase dryness, redness or irritation of the skin.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if neede. If bothersome dryness or peeling occurs, reduce application to once per day.
    • Do not use for prolonged periods without contacting a doctor.

    When using this product

    • Avoid contact with eyes. of contact occurs, flush thoroughly with water. Keep away from lips and mouth.
    • Avoid unnecessary sun exposure and use a sunscreen.
    • Avoid Product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this Product.

    Stop use and ask a doctor

    if excessive irritation occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Cleanse Skin thoroughly before applying medication. Apply even layer over affected area. Rinse well. DO not use on broken skin or large parts of the body. For best results, apply one to three times per day.

  • Inactive ingredients

    Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide.

  • Product Label

    Box

  • INGREDIENTS AND APPEARANCE
    HUMANE ACNE WASH 
    benzoly peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69919-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69919-021-011 in 1 CARTON02/08/2017
    1237 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/28/2015
    Labeler - Humane Consumer, LLC (079845933)
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