Label: WALGREENS MAXIMUM STRENGTH ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 3, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 10%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne

  • Warnings

    For external use only.

    Do not use if you

    have very sensitive
    are sensitive to benzoyl peroxide

    When using this product

    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 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
    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.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    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, 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 use of both products and ask a doctor.
  • Other information

    keep tightly closed
    store at room temperature
  • Inactive ingredients

    bentonite, carbomer, ethylhexylglycerin, glyceryl stearate, isopropyl myristate, PEG-12 dimethicone, phenoxyethanol, potassium hydroxide, propylene glycol, water.

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    MAXIMUM STRENGTH
    Acne Treatment Gel
    10% BENZOYL PEROXIDE / ACNE MEDICATION

    NET WT 1 OZ (28 g)

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS MAXIMUM STRENGTH ACNE TREATMENT  ACNE MEDICATION
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8798
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Bentonite (UNII: A3N5ZCN45C)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8798-011 in 1 CARTON03/14/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00603/14/2023
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(0363-8798) , LABEL(0363-8798) , PACK(0363-8798)