Label: AF FOAM CLEAR SKIN ACNE PORE CLEANSER- benzoyl peroxide aerosol, foam

  • Category: HUMAN OTC DRUG LABEL

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 December 8, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: Benzoyl Peroxide 2.5% w/v
  • PURPOSE

    Purpose: Acne Treatment
  • INDICATIONS & USAGE

    Use for the treatment of acne.
  • WARNINGS

    Warnings For external use only.
  • DO NOT USE

    Do not use: If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use: If you are using other topical acne drugs at the same time or right before 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

    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 with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
  • STOP USE

    Stop use and ask a doctor: If excessive irritation occurs.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    • Use AM and PM. Recommended: After AM use, follow with AcneFree All-Day Acne Control. After PM use, follow with 3-in-1 Acne Night Repair.
    • Moisten skin.
    • Shake well before each use.
    • Hold Can upright and press down firmly on dispenser. Apply a small amount of foam (not more than a dollop the size of a gold ball) into hand.
    • Using fingers, apply to face and gently massage to cleanse.
    • Rinse thoroughly with warn water and pat dry.
    • If bothersome peeling occurs, reduce application use.
    • If going outside, use a sunscreen.
  • INACTIVE INGREDIENT

    Inactive ingredients: Benzylkonium Chloride, Caprylic/Capric Triglyceride, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Decyl Glucoside, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Glycerin,  Glyceryl Sterate, Isobutane, Magnesium Aluminum Silicate, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propane, Sea Whip Extract, Sodium Benzoate, Sodium Polyacrylate, Stearic Acid, Water, Xanthan Gum.

  • STORAGE AND HANDLING

    Other Information
    • Store at 60o-85oF (15o-30oC).
    • Pressurized container: protect from sunlight and do not expose to temperatures exceeding 120oF(49oC). Do not puncture or birn, even after use. Use only as directed.
  • PRINCIPAL DISPLAY PANEL

    AcneFree Clear Skin treatments

    Oil-Free Acne Pore Cleanser
    Micro-Benzoyl Peroxide 2.5%

    Rinse-Off Foam
    Medicine Stays in Pores Even After Rinsing
    Drug Facts 1
    Drug Facts 2
    Label



  • INGREDIENTS AND APPEARANCE
    AF FOAM CLEAR SKIN ACNE PORE CLEANSER 
    benzoyl peroxide aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    glycerin (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    propane (UNII: T75W9911L6)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    isobutane (UNII: BXR49TP611)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-301-4085 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/01/2011
    Labeler - University Medical Pharmaceuticals Corp (809706252)
    Registrant - University Medical Pharmaceuticals Corp (809706252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, INC177711082manufacture
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