Label: BENZOYL PEROXIDE liquid

  • NDC Code(s): 35573-453-08, 35573-453-91, 35573-454-08, 35573-454-91
  • Packager: Burel Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 24, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    benzoyl peroxide USP, 5% or 10%

  • Purpose

    Acne medication

  • Use

    • For the treatment of acne
  • Warnings:

    For external use only.

    • Avoid contact with eyes, eyelids, lips and mucous membranes.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    When using this product

    • Avoid unnecessary sun exposure and use a sunscreen.
    • Avoid contact with eyes, lips, and mouth.
    • Avoid contact with hair or 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.
    • 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.
    • 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

    SHAKE WELL.

    • Clean the skin thoroughly before applying this product.
    • 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 below.
    • One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
    • 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.
    • Follow directions in the sunscreen labeling.
    • If irritation or sensitivity develops stop use of both products and ask a doctor.
  • Other information

    Store at controlled room temperature, 15° - 30°C (59° - 86°F)

  • Inactive Ingredients

    Carbomer interpolymer type A NF, cetyl alcohol NF, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

  • SPL UNCLASSIFIED SECTION

    Questions? Call 1-866-525-0688

    Manufactured for:
    Burel Pharmaceuticals, LLC
    Mason, OH 45040 USA

    Rev. 04/24

  • PRINCIPAL DISPLAY PANEL - 5% 5oz (148 g) Bottle Label

    NDC 35573-453-91

    BENZOYL
    PEROXIDE
    TOPICAL
    WASH 5%

    FOR TOPICAL USE ONLY

    Net Weight 5 oz
    (148 g)

    burelpharma

     

    lelys

  • PRINCIPAL DISPLAY PANEL - 5% 8oz (237 g) Bottle Label

    NDC 35573-453-08

    BENZOYL
    PEROXIDE
    TOPICAL
    WASH 5%

    FOR TOPICAL USE ONLY

    Net Weight 8 oz
    (237 g)

    burelpharma

    lelys

  • PRINCIPAL DISPLAY PANEL - 10% 5oz (148 g) Bottle Label

    NDC 35573-454-91

    BENZOYL
    PEROXIDE
    TOPICAL
    WASH 10%

    FOR TOPICAL USE ONLY

    Net Weight 5 oz
    (148 g)

    burelpharma

    lelys1
  • PRINICIPAL DISPLAY PANEL - 10% 8oz (237 g) Bottle Label

    NDC 35573-454-08

    BENZOYL
    PEROXIDE
    TOPICAL
    WASH 10%

    FOR TOPICAL USE ONLY

    Net Weight 8 oz
    (237 g)

    burelpharma

     
    lelys3
  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35573-453
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    cetyl alcohol (UNII: 936JST6JCN)  
    edetate disodium (UNII: 7FLD91C86K)  
    glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    laureth-12 (UNII: OAH19558U1)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium coco-sulfate (UNII: 3599J29ANH)  
    sodium lauroamphoacetate (UNII: SLK428451L)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35573-453-91148 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
    2NDC:35573-453-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/15/2022
    BENZOYL PEROXIDE 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35573-454
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    cetyl alcohol (UNII: 936JST6JCN)  
    edetate disodium (UNII: 7FLD91C86K)  
    glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    laureth-12 (UNII: OAH19558U1)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium coco-sulfate (UNII: 3599J29ANH)  
    sodium lauroamphoacetate (UNII: SLK428451L)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35573-454-91148 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
    2NDC:35573-454-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/15/2022
    Labeler - Burel Pharmaceuticals, LLC (609436204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Groupe PARIMA Inc.252437850label(35573-453, 35573-454) , manufacture(35573-453, 35573-454) , pack(35573-453, 35573-454)
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