Label: DAILY LEAVE ON ACNE TREATMENT MASK- benzoyl peroxide cream

  • NDC Code(s): 62742-4212-1, 62742-4212-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2024

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

  • ACTIVE INGREDIENT


    Active Ingredients
    Benzoyl Peroxide 2.5%

  • PURPOSE


    Purpose
    Acne Treatment

  • INDICATIONS & USAGE


    Uses
    For the treatment of acne

  • WARNINGS


    Warnings
    For external use only

  • DO NOT USE


    Do not use
    If you have very sensitive skin
    Are sensitive to benzoyl
    peroxide

  • WHEN USING


    When using this product
    • Avoid unnecessary sun
    exposure & use a sunscreen
    • Avoid contact with the
    eyes, lips, and mouth
    • Avoid contact with hair &
    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


    Stop use and ask a doctor
    If irritation becomes severe

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children
    If product is swallowed,
    get medical help or
    contact a Poison Control
    Center right away.

  • DOSAGE & ADMINISTRATION


    Directions
    • Clean the skin thoroughly
    before applying this product
    • Cover the entire affected
    area with a thin layer one
    to three 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.

  • OTHER SAFETY INFORMATION


    Other Information
    Store at 20°- 25°C (68° - 77°F)

  • INACTIVE INGREDIENT


    Inactive Ingredients
    Water (Aqua), Aloe Barbadensis
    Leaf Juice, Glycerin, Serenoa
    Serrulata (Saw Palmetto) Fruit
    Extract, Niacinamide, Linoleic
    Acid, Linolenic Acid, Docosahexaenoic
    Acid, Eicosapentaenoic
    Acid, Scutellaria Baicalensis
    Root Extract, Zinc Gluconate,
    Tocopherol, Dimethicone,
    Silica, Carbomer, Caprylyl
    Glycol, Diethylhexyl Sodium
    Sulfosuccinate, Ethylhexylglycerin,
    Hexylene Glycol, PEG-40
    Stearate, Phenoxyethanol,
    Propanediol, Sodium
    Hydroxide, Sodium Citrate,
    Sodium Phytate, Sorbitan
    Stearate, Xanthan Gum.

  • PRINCIPAL DISPLAY PANEL

    daily leave on acne treatment mask

  • INGREDIENTS AND APPEARANCE
    DAILY LEAVE ON ACNE TREATMENT MASK 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DOCONEXENT (UNII: ZAD9OKH9JC)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ICOSAPENT (UNII: AAN7QOV9EA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4212-21 in 1 CARTON04/02/2022
    1NDC:62742-4212-145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/02/2022
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure LAbs926831603manufacture(62742-4212)