Label: EQUATE ACNE WASH ACNE MEDICATION- 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 February 10, 2023

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 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

    • 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
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the 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.

    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) 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

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

  • Questions or comments?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 156 g Tube Carton

    NDC 79903-061-01

    equate™
    beauty

    Compare to PanOxyl®
    active ingredient*

    ACNE
    WASH
    10% Benzoyl Peroxide

    MAXIMUM STRENGTH

    For treatment of acne on face,
    chest & back
    Improves the appearance of
    existing blemishes
    Helps prevent future breakouts

    SULFATE
    FREE
    PARABEN

    NET WT 5.5 OZ (156g)

    PRINCIPAL DISPLAY PANEL - 156 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE ACNE WASH   ACNE MEDICATION
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-061
    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
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3)  
    PEG-40 Stearate (UNII: ECU18C66Q7)  
    Propanediol (UNII: 5965N8W85T)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-061-011 in 1 CARTON04/30/2021
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D04/30/2021
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(79903-061)