Label: BENZOYL PEROXIDE liquid

  • NDC Code(s): 67405-825-05, 67405-825-08
  • Packager: Harris Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 24, 2019

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    5% benzoyl peroxide USP

  • 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.
    • 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° - 25°C (59° - 77°F)

  • Inactive Ingredients

    Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, 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

    Manufactured for:
    Harris Pharmaceutical, Inc.,
    Fort Myers, FL 33908
    Manufactured by:
    Groupe Parima
    Montreal, QC
    H4S 1X6 CANADA Rev 06/11

  • PRINCIPAL DISPLAY PANEL - 148 g Bottle Label

    NDC 67405-825-05

    BENZOYL
    PEROXIDE
    TOPICAL
    WASH 5%

    FOR TOPICAL USE

    Net Weight 5 oz
    (148 g)

    HARRIS

    Principal Display Panel - 148 g Bottle Label

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67405-825
    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
    cetyl alcohol (UNII: 936JST6JCN)  
    DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)  
    edetate disodium (UNII: 7FLD91C86K)  
    glycerin (UNII: PDC6A3C0OX)  
    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:67405-825-05148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/2011
    2NDC:67405-825-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/18/2011
    Labeler - Harris Pharmaceutical, Inc. (617204370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Groupe Parima Montreal252437850MANUFACTURE(67405-825)