Label: VIVANT BP3% ACNE WASH- benzoyl peroxide liquid

  • NDC Code(s): 63750-004-04
  • Packager: Vivant Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • Active ingredient

    Benzoyl peroxide 3%

    Purpose

    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

    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

    if rash or irritation develops an last

    Keep out of reach of children.

    If a product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flus thoroughly with water.

  • Directions

    Directions ■ Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area.
    Rinse thoroughly and pat dry. ■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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 using this product and ask a doctor.

  • Inactive Ingredients

    Inactive Ingredients: Water, Ammonium Lauryl Sulfate, Glycerin, Propylene Glycol, Disodium Cocoamphodiacetate, Carbomer, Sodium Hydroxide

  • Other Information

    Other Information
    ■ Keep tightly closed. Avoid storing at temperatures above 90°F.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    VIVANT BP3% ACNE WASH 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63750-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63750-004-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/01/2024
    Labeler - Vivant Pharmaceuticals, LLC (782696814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivant Pharmaceuticals, LLC782696814manufacture(63750-004)
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