Label: OXY MAXIMUM ACTION SPOT TREATMENT TINTED- benzoyl peroxide cream

  • NDC Code(s): 10742-8302-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Active ingredient

    Benzoyl peroxide 10%

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  • Purpose

    Acne treatment

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  • Uses

    treats and helps prevent acne

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  • 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

    If pregnant or breast-feeding

    ask a health professional before use.

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  • Keep Out of Reach of Children

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

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  • Directions

    clean skin thoroughly before applying this product
    cover entire affected area with a thin layer 1 to 3 times daily
    because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
    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.
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  • Other information

    avoid storing at temperatures above 100°F (38°C)
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  • Inactive ingredients

    anhydrous citric acid, butylene glycol, carbomer homopolymer, diazolidinyl urea, dimethicone, dimethyl isosorbide, edetate disodium, fragrance, glycerin, iodopropynyl butylcarbamate, iron oxides, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG-8 methyl ether triethoxysilane, PEG/PPG-4/12 dimethicone, portulaca oleracea extract, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, talc, titanium dioxide, xanthan gum

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  • Questions?

    Toll free 1-877-636-2677

    MON-FRI 9 AM-5 PM (EST)

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    OXY MAXIMUM ACTION SPOT TREATMENT  TINTED
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-8302
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    BUTYLENE GLYCOL  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    DIAZOLIDINYL UREA  
    DIMETHICONE  
    DIMETHYL ISOSORBIDE  
    EDETATE DISODIUM  
    GLYCERIN  
    IODOPROPYNYL BUTYLCARBAMATE  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER  
    PEG/PPG-4/12 DIMETHICONE  
    PURSLANE  
    PROPYLENE GLYCOL  
    WATER  
    SILICON DIOXIDE  
    SODIUM CITRATE  
    SODIUM HYDROXIDE  
    TALC  
    TITANIUM DIOXIDE  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-8302-1 1 in 1 CARTON
    1 18.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333D 01/15/2013
    Labeler - The Mentholatum Company (002105757)
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