Label: OXY ADVANCED CARE RAPID SPOT TREATMENT- benzoyl peroxide gel

  • NDC Code(s): 10742-1201-1, 10742-1201-2, 10742-1201-3
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • Active ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne treatment

  • Uses

    • for the treatment of acne
    • helps prevent new acne blemishes 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

    • clean the skin thoroughly before applying this product
    • cover the 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.

    Other Safety Information

    • avoid storing at temperatures above 100 OF (38 OC)
  • Inactive Ingredients

    water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, xanthan gum

    Questions

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

  • Package/Label Principal Display Panel

    Image 1

  • INGREDIENTS AND APPEARANCE
    OXY  ADVANCED CARE RAPID SPOT TREATMENT
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PURSLANE (UNII: M6S840WXG5)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1201-11 in 1 CARTON07/12/2021
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10742-1201-21 in 1 CARTON12/01/2021
    232.6 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10742-1201-31 in 1 CARTON02/21/2022
    318.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/12/2021
    Labeler - The Mentholatum Company (002105757)
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