Label: OXY ADVANCED CARE SENSITIVE SKIN ACNE CLEANSER- benzoyl peroxide gel

  • NDC Code(s): 10742-1203-1, 10742-1203-2
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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

  • Active ingredient

    Benzoyl peroxide 5%

  • Purpose

    Acne treatment

  • Uses

    • for the treatment of acne
    • clears acne pimples and allows skin to heal
    • penetrates pores to control blackheads and whiteheads
    • helps prevent new acne pimples from forming
  • 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 the 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 massage gently onto face
    • rinse thoroughly and pat dry
    • 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.
  • 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, chlorphenesin, citric acid, glycerin, hydrolyzed soy protein, PEG-8 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

  • Questions?

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

  • Principal Display Panel

    Tube
  • INGREDIENTS AND APPEARANCE
    OXY  ADVANCED CARE SENSITIVE SKIN ACNE CLEANSER
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    PURSLANE (UNII: M6S840WXG5)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1203-1148 mL in 1 TUBE; Type 0: Not a Combination Product09/20/2021
    2NDC:10742-1203-2170 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/20/2021
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-1203)