Label: OXY 10 ACNE CLEANSER- benzoyl peroxide cream

  • NDC Code(s): 10742-1397-1, 10742-1397-2
  • Packager: The Mentholatum Company
  • 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 February 7, 2023

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  • Active ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne treatment

  • Uses

    treats and helps prevent acne

  • 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.

  • Keep Out of Reach of Children

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

  • Directions

    • wet face
    • apply to hands then work into a lather and massage gently onto face
    • rinse thoroughly and pat dry
    • because excessive drying of the skin may occur, start with 1 use 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 usage 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.
    • Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.
  • Other information

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

    water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

  • Questions?

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

  • Package/Label Principal Display Panel

    Oxy 10 Acne Cleanser
  • INGREDIENTS AND APPEARANCE
    OXY 10 ACNE CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1397
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1397-1148 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    2NDC:10742-1397-2185 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-1397)
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