Label: ACNEFREE OIL-FREE ACNE CLEANSER- 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 February 22, 2017

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

  • Drug Facts

  • Active ingredient

    Benzoyl Peroxide 2.5% w/v

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Do not use if you

    have very sensitive skin
    are sensitive to benzoyl peroxide

    When using this product

    skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    avoid unnecessary sun exposure and use a sunscreen
    avoid contact with the eyes, lips, and mouth
    avoid contact with hair and dyed fabrics, which may be bleached by this product
    skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

    Stop use and ask a doctor if

    irritation becomes severe

    Keep out of reach of children.

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

  • Directions

    use every morning and evening
    apply a dime-size amount to damp skin and gently massage, avoiding the eye area
    if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
    may also be used on chest or back.
  • Inactive ingredients

    water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP

  • Questions/comments?

    1-800-321-4576

  • PRINCIPAL DISPLAY PANEL – 8 FL. OZ. Bottle Label

    AcneFree Oil-Free Acne Cleanser - 8 fl oz Bottle Label

    NEW

    LOOK

    AcneFree®

    CLEAR SKIN TREATMENTS

    Oil-Free

    Acne

    Cleanser

    Advanced

    Micro-Benzoyl Peroxide

    8 FL. OZ. (237 mL)

  • INGREDIENTS AND APPEARANCE
    ACNEFREE  OIL-FREE ACNE CLEANSER
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1613
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-1613-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2013
    2NDC:0187-1613-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2013
    Labeler - Valeant Pharmaceuticals North America LLC (042230623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274MANUFACTURE(0187-1613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc.790530976MANUFACTURE(0187-1613)