Label: OXY TOTAL CARE CLARIFYING MOISTURIZER- benzoyl peroxide lotion

  • NDC Code(s): 10742-1314-1
  • 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 2.5%

  • Purpose

    Benzoyl peroxide – Acne treatment

  • Keep Out of Reach of Children

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

  • Uses

    • For the treatment of acne.
    • Helps prevent new acne blemishes.
  • 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, use only 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.

  • Directions

    • clean the skin thoroughly before applying this product
    • use a dime-sized amount to cover the entire affected area with a thin layer one to two times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
    • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated 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, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfate

    Questions?1-877-636-2677

    MON-FRI 9AM-5PM (EST)

  • Package/Label Principal Display Panel

    Oxy Total Care Clarifying Moisturizer
  • INGREDIENTS AND APPEARANCE
    OXY  TOTAL CARE CLARIFYING MOISTURIZER
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    PURSLANE (UNII: M6S840WXG5)  
    SILANETRIOL (UNII: E52D0J3TS5)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1314-11 in 1 CARTON09/30/2019
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/30/2019
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-1314)