Label: OIL-FREE ACNE CLEANSER- benzoyl peroxide cream

  • 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 November 1, 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 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 INGREDIENT

    Inactive ingredients: Water, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Cocamidopropyl Betaine, Bakuchiol, Panthenyl Triacetate, Bisabolol, Benzalkonium Chloride, Chamomilla Recuita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Polyethylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Capric Triglyeride, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

    AcneFree Clear Skin Treatments

    Oil-Free Acne Cleanser
    Gentle Exfoliating Microbeads

    Advanced Micro-Benzoyl Peroxide
    Artwork for Bottle

  • INGREDIENTS AND APPEARANCE
    OIL-FREE ACNE CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (benzoic acid - UNII:8SKN0B0MIM) 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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    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)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-001-06237 g in 1 BOTTLE, PLASTIC
    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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