Label: OXY DAILY DEFENSE EXFOLIATING BODY SCRUB- salicylic acid gel

  • NDC Code(s): 10742-8291-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

    Salicylic acid 1%

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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

    When using this product

    keep away from eyes. If contact occurs, flush thoroughly with water.
    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.

    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

    lather onto skin, thoroughly cleansing areas prone to breakouts, then rinse well
    because too much drying of the skin may occur, start with 1 use, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
    if bothersome dryness or peeling occurs, reduce usage to once a day or every other day
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  • Inactive ingredients

    acrylates copolymer, aloe barbadensis leaf juice, anhydrous citric acid, benzoic acid, butylene glycol, cocamidopropyl betaine, dehydroacetic acid, edetate disodium, FD&C yellow no. 6, ficus carica (fig) fruit extract, fragrance, glycerin, jojoba esters, panthenol, phenoxyethanol, polyethylene, potassium C12-13 alkyl phosphate, purified water, sodium C14-16 olefin sulfonate, trolamine

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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 DAILY DEFENSE EXFOLIATING BODY SCRUB 
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-8291
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    ALOE VERA LEAF  
    ANHYDROUS CITRIC ACID  
    BENZOIC ACID  
    BUTYLENE GLYCOL  
    COCAMIDOPROPYL BETAINE  
    DEHYDROACETIC ACID  
    EDETATE DISODIUM  
    FD&C YELLOW NO. 6  
    FIG  
    GLYCERIN  
    HYDROLYZED JOJOBA ESTERS (ACID FORM)  
    PANTHENOL  
    PHENOXYETHANOL  
    WATER  
    SODIUM C14-16 OLEFIN SULFONATE  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-8291-1 295 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/15/2013
    Labeler - The Mentholatum Company (002105757)
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