Label: BENZOYL PEROXIDE 5% TOPICAL WASH- benzoyl peroxide liquid
BENZOYL PEROXIDE 10% TOPICAL WASH- benzoyl peroxide liquid

  • NDC Code(s): 82461-312-05, 82461-312-08, 82461-313-05, 82461-313-08
  • Packager: Medcore LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 22, 2025

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

  • Drug Facts

  • Active ingredient

    BENZOYL PEROXIDE 5% or 10%

    Purpose

    Acne medication

  • Uses

    For the treatment of acne

  • Warnings

    For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair,dyed fabrics, which may be bleached by thisproduct. 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 lower concentration.If irritation or sensitivy develops stop use of both products and ask a doctor.

  • INSTRUCTIONS FOR USE

    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, 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

  • -
    allergic reaction occurs
    -
    condition worsens or does not improve within 7 days
    -
    symptoms clear up and return within a few days
    -
    redness, irritation, swelling, pain or other symptoms begin or increase
  • Keep out of the reach of children.

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

  • Directions

    adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
    children under 2 yearsask a doctor
  • Other information

    Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

  • Inactive Ingredients

    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL

  • PRINCIPAL DISPLAY PANEL - 5% 5 OZ Bottle Label

    NDC: 82461-312-05

    Medcore LLC

    BENZOYL PEROXIDE 5% Acne wash

    5 OZ

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

    Label-1

  • PRINCIPAL DISPLAY PANEL - 5% 8 OZ Bottle Label

    NDC: 82461-312-08

    Medcore LLC

    BENZOYL PEROXIDE 5% Acne wash

    8 OZ

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

    Label-1

  • PRINCIPAL DISPLAY PANEL - 10% 5 OZ Bottle Label

    NDC: 82461-313-05

    Medcore LLC

    BENZOYL PEROXIDE 10% Acne wash

    5 OZ

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

    Label-1

  • PRINCIPAL DISPLAY PANEL - 10% 8 OZ Bottle Label

    NDC: 82461-313-08

    Medcore LLC

    BENZOYL PEROXIDE 10% Acne wash

    8 OZ

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

    Label-1

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 5% TOPICAL WASH 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82461-312
    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)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82461-312-05148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
    2NDC:82461-312-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/20/2025
    BENZOYL PEROXIDE 10% TOPICAL WASH 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82461-313
    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)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82461-313-05148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
    2NDC:82461-313-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/20/2025
    Labeler - Medcore LLC (069802634)