Label: OXY MAXIMUM ACTION TREATMENT PADS- benzoyl peroxide swab

  • NDC Code(s): 10742-8352-1
  • 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 2.5%

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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
    use a pad to cover the affected area with a thin layer of medicine 1 to 3 times daily
    because excessive drying of the skin may occur, start with one 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

    THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
    KEEP TIGHTLY CLOSED
    Avoid storing at temperatures above 100°F (38°C)
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  • Inactive Ingredients

    anhydrous citric acid, bentonite, caprylic/capric triglyceride, cetostearyl alcohol, cyclohexasiloxane, cyclopentasiloxane, dimethicone, edetate disodium, ethylhexylglycerin, fragrance, glyceryl monostearate, methyl methacrylate/glycol dimethacrylate crosspolymer, PEG-100 stearate, phenoxyethanol, propanediol, purified water, sodium citrate, sodium hydroxide, steareth-20, xanthan gum

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  • Questions?

    1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

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  • Package/Label Principal Display Panel
  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    OXY MAXIMUM ACTION TREATMENT PADS 
    benzoyl peroxide swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-8352
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    BENTONITE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    CETOSTEARYL ALCOHOL  
    CYCLOMETHICONE 6  
    CYCLOMETHICONE 5  
    DIMETHICONE  
    EDETATE DISODIUM  
    ETHYLHEXYLGLYCERIN  
    GLYCERYL 1-STEARATE  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER  
    PEG-100 STEARATE  
    PHENOXYETHANOL  
    PROPANEDIOL  
    WATER  
    SODIUM CITRATE  
    SODIUM HYDROXIDE  
    STEARETH-20  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-8352-1 30 in 1 POUCH
    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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