Label: WALGREENS ACNE FOAMING CLEANSER ACNE TREATMENT- benzoyl peroxide cream

  • 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 6, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 4%

  • Purpose

    Acne Treatment

  • 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

    ♦
    skin irritation and dryness are more likely to occur if you use another topical acne medication at the same 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

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

  • Directions

    ♦
    apply a dime-size amount to damp skin and gently massage, avoiding the eye area
    ♦
    use wash on entire affected area
    ♦
    begin with one application daily then gradually increase to two times daily if needed or as directed by a doctor
    ♦
    if severe 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

    water, cocamidopropyl hydroxysultaine, glycerin, sodium C14-16 olefin sulfonate, propylene glycol, xanthan gum, propanediol, diethylhexyl sodium sulfosuccinate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, phenoxyethanol, phytosphingosine, disodium EDTA, ethylhexylglycerin.

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton

    Walgreens

    Compare to CeraVe® Acne
    Foaming Cream Cleanser††

    NEW
    Acne
    Foaming
    Cream
    Cleanser

    BENZOYL PEROXIDE 4% /
    ACNE TREATMENT

    FRAGRANCE FREE

    NON-COMEDOGENIC

    DAILY

    • Clears acne pimples
      & blackheads
    • Helps prevent new
      acne from forming
    • Formulated to
      be gentle on skin

    5 FL OZ (150 mL)

    PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS ACNE FOAMING CLEANSER   ACNE TREATMENT
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0467
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Propanediol (UNII: 5965N8W85T)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Ceramide NP (UNII: 4370DF050B)  
    Ceramide AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Niacinamide (UNII: 25X51I8RD4)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0467-011 in 1 CARTON06/29/2021
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/29/2021
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(0363-0467)
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