Label: OIL-FREE ACNE CLEANSER - benzoyl peroxide cream

  • NDC Code(s): 50544-001-06
  • Packager: University Medical Pharmaceuticals Corp
  • 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 November 1, 2011

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

  • ACTIVE INGREDIENT

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

    Purpose: Acne Treatment
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  • INDICATIONS & USAGE

    Use for the treatment of acne.
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  • WARNINGS

    Warnings For external use only.
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  • DO NOT USE

    Do not use: If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.
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  • 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.
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  • 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.
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  • STOP USE

    Stop use and ask a doctor: If excessive irritation occurs.
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  • 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.
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  • 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.
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  • 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.

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  • PRINCIPAL DISPLAY PANEL

    AcneFree Clear Skin Treatments

    Oil-Free Acne Cleanser
    Gentle Exfoliating Microbeads

    Advanced Micro-Benzoyl Peroxide
    Artwork for Bottle

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  • INGREDIENTS AND APPEARANCE
    OIL-FREE ACNE CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50544-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (benzoic acid - UNII:8SKN0B0MIM) Benzoyl Peroxide 2.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50544-001-06 237 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 11/01/2011
    Labeler - University Medical Pharmaceuticals Corp (809706252)
    Registrant - University Medical Pharmaceuticals Corp (809706252)
    Establishment
    Name Address ID/FEI Business Operations
    Universal Packaging Systems, INC 177711082 manufacture
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