Label: WALGREENS ACNE CONTROL CLEANSER 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 28, 2023

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  • 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 skin
    ♦
    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 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 consult 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) right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Directions

    Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry.

    Recommended for use twice daily.

    If going outside, use a sunscreen.

  • Other information

    store at room temperature.

  • Inactive ingredients

    glycerin, petrolatum, mineral oil, C12-15 alkyl benzoate, water, sodium cocoyl isethionate, sodium C14-16 olefin sulfonate, zinc lactate, acrylates/C10-30 alkyl acrylate crosspolymer, menthol, fragrance, potassium polymetaphosphate, titanium dioxide, carbomer.

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 142 g Tube Label

    Walgreens

    Compare to the active ingredient
    in Clean & Clear® Continuous
    Control® Acne Cleanser††

    • WALGREENS •
    PHARMACIST RECOMMENDED†

    Acne
    Control
    Cleanser

    10% BENZOYL PEROXIDE /
    ACNE TREATMENT

    Daily Use

    • Works to get deep
      into pores
    • Helps fight breakouts
      long after you wash
    • Paraben free &
      phthalate free

    NET WT 5 OZ (142 g)

    PRINCIPAL DISPLAY PANEL - 142 g Tube Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS ACNE CONTROL CLEANSER   ACNE MEDICATION
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3602
    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
    Glycerin (UNII: PDC6A3C0OX)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Water (UNII: 059QF0KO0R)  
    Sodium Cocoyl Isethionate (UNII: 518XTE8493)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Zinc Lactate (UNII: 2GXR25858Y)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM METAPHOSPHATE (UNII: 01DMT14Z63)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3602-01142 g in 1 TUBE; Type 0: Not a Combination Product03/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D03/03/2023
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, INC (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(0363-3602) , LABEL(0363-3602) , PACK(0363-3602)
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