Label: HUMANE ACNE WASH- benzoyl peroxide liquid

  • 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 June 4, 2019

If you are a consumer or patient please visit this version.

  • 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 this 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 needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    When using this product

    • Avoid contact with and near eyes. If 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

    New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 3-5 minutes for wash to absorb. Rinse thoroughly.

  • Inactive ingredients

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HUMANE ACNE WASH 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73010-900
    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)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73010-900-00237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/01/2019
    Labeler - Apprendista, LLC (116995922)