Label: WALGREENS ACNE FOAMING WASH ACNE MEDICATION- benzoyl peroxide lotion

  • 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 July 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 10%

  • Purpose

    Acne medication

  • Use

    ♦
    for 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

    ♦
    skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only 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 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 right away.

  • Directions

    ♦
    wet area to be cleansed
    ♦
    apply acne wash and gently massage area for 1-2 minutes
    ♦
    rinse thoroughly and pat dry
    ♦
    because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 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

    Store at room temperature

  • Inactive ingredients

    ammonium acryloyldimethyltaurate/VP copolymer, carbomer, decyl glucoside, diethylhexyl sodium sulfosuccinate, dimethicone, glycerin, PEG-40 stearate, propanediol, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium hydroxypropylsulfonate laurylglucoside crosspolymer, sorbitan stearate, stearic acid, xanthan gum, water

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 156 g Tube Label

    Walgreens

    Compare to PanOxyl®
    active ingredient††

    MAXIMUM STRENGTH

    Acne
    Foaming Wash

    10% BENZOYL PEROXIDE / ACNE TREATMENT

    PARABEN FREE
    SULFATE FREE

    • For face, chest & back
    • Benzoyl peroxide kills the
      bacteria that can cause acne
    • Improves the appearance
      of existing blemishes &
      prevents future breakouts

    NET WT 5.5 OZ (156 g)

    PRINCIPAL DISPLAY PANEL - 156 g Tube Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS ACNE FOAMING WASH   ACNE MEDICATION
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1522
    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
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycerin (UNII: PDC6A3C0OX)  
    PEG-40 Stearate (UNII: ECU18C66Q7)  
    Propanediol (UNII: 5965N8W85T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1522-01156 g in 1 TUBE; Type 0: Not a Combination Product03/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D03/15/2019
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(0363-1522)
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