Label: SOFIE PAVITT FACE RESET BENZOYL PEROXIDE ACNE TREATMENT MASK- benzoyl peroxide paste

  • NDC Code(s): 52261-7301-1
  • Packager: Cosco International, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

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  • Active Ingredient/Purpose

    Benzoyl Peroxide............Acne Treatment

  • Use

    For the treatment of acne

  • Warnings

    For external use only

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    Ask doctor before use

    if you have redness over the affected area

    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

    Keep out of reach of children.

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

  • Directions

    • Clean the skin throughly before applying this product
    • Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly.
    • Use once a day or as directed by a doctor.
    • If dryness or peeling occurs, reduce application to once every other day.
    • If going outside, apply sunscreen after using this product.
    • If irritation or sensitivity develops, discontinue use and consult a doctor.
  • Other Information

    Store at room temperature 20°-25°C (68°-77°F)

    Protect from heat and direct sunlight.

  • Inactive Ingredients

    Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Glycolic Acid, Niacinamide, Panthenol, Phenoxyethanol, Ethylhexylglycerin,  Hydroxyethylcellulose, Carbomer, Xanthan Gum, Tocopheryl Acetate, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    2oz tube label

  • PRINCIPAL DISPLAY PANEL

    2oz carton label

  • INGREDIENTS AND APPEARANCE
    SOFIE PAVITT FACE RESET BENZOYL PEROXIDE ACNE TREATMENT MASK 
    benzoyl peroxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-7301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide0.05 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-7301-11 in 1 CARTON11/11/2024
    10.0618 kg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/11/2024
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-7301) , label(52261-7301) , pack(52261-7301)
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