Label: ACNEFREE CLEAR SKIN TREATMENTS ADVANCED DEEP CLEANSING DUO- benzoyl peroxide kit

  • 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 July 16, 2015

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 are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.

    Ask a doctor or pharmacist before use

    if you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness, or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

    When using this product

    Avoid contact with 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

    Use every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome peeling occurs, reduce application use. 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

  • Preparing the Advanced Cleansing Brush for Use

    Installing brush head: Press the brush head onto unit until it locks into position with a click.

    Installing batteries: Remove battery cover. Insert 2 AA batteries, aligning +/- symbols. Replace batteries as needed. Do not mix old and new batteries as unit may become damaged.

  • Directions

    Use once a day. Dampen skin, rinse brush head and pat dry to remove excess water before attaching to brush unit. Apply any AcneFree cleanser to brush head, spreading a dime-size amount evenly over brush surface; this will avoid product from splattering onto clothing while brush is in motion. (Cleansers with Benzoyl Peroxide may bleach clothing/towels.) Gently massage over face for approximately 60 seconds, concentrating on troubled areas. Avoid the eye and mouth area. Be careful not to press too hard; this will limit the motion of the brush and reduce its effectiveness. Rinse face, remove brush head, and rinse thoroughly. Recommended: For sensitive skin, use 2-3 times a week on low speed. If any slight redness occurs after use, it should fade within half an hour.

  • How to Care for Your Advanced Cleansing Brush

    To keep your Advanced Cleansing Brush in good condition, do not use abrasive cleansers or chemicals to clean any part of the brush. Do not put any part of the Advanced Cleansing Brush unit in a dishwasher. Do not submerge the Advanced Cleansing Brush in water.

    For best results: After use, remove the brush head from handle and rinse with warm soapy water to remove any residue.

  • Warnings

    Avoid direct contact with eyes and hairline/hair. If skin irritation or redness occurs, reduce frequency of use. As this product increases exfoliation of the skin, it may also increase your skin’s sensitivity to the sun. Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL – AcneFree Advanced Deep Cleansing Duo

    AcneFree Advanced Deep Cleansing Duo

    AcneFree®

    CLEAR SKIN TREATMENTS

    CLEANS 15X BETTER*

    Advanced

    Deep Cleansing Duo

    2-SPEED FACIAL CLEANSING BRUSH + OIL-FREE PURIFYING CLEANSER

    Gently Deep-Cleans Pores
    Clears Blackheads + Breakouts
    Ultra-Soft Bristles
    Waterproof

    CONTAINS: 1 CLEANSING BRUSH, 2 BRUSH HEADS, 2 AA BATTERIES, CLEANSER 4 FL. OZ. (118 mL)

    *then leading cleanser alone

  • INGREDIENTS AND APPEARANCE
    ACNEFREE CLEAR SKIN TREATMENTS  ADVANCED DEEP CLEANSING DUO
    benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5012
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-5012-021 in 1 CARTON; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 1 of 1
    ACNEFREE CLEAR SKIN TREATMENTS 
    benzoyl peroxide liquid
    Product Information
    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
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/25/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/25/2014
    Labeler - Valeant Pharmaceuticals North America LLC (042230623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc.790530976MANUFACTURE(0187-5012)