Label: ACNE FACE AND BODY- benzoyl peroxide shampoo, suspension

  • NDC Code(s): 70707-101-01, 70707-101-06
  • Packager: Face Reality, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

    Purpose

    For the treatment of Acne

  • Uses

    Adults and children 12 years and over:

    • For the treatment of acne.
    • For acne-prone or oily skin.
  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with eyes and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor.

    Do not use

    this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.

    Keep out of reach of children.

  • Directions

    Use 1 to 3 times daily on affected skin, work into lather, rinse off thoroughly.

  • Other Information

    May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.

  • Inactive Ingredients

    Purified Water, Ammonium Lauryl Sulfate, Glycerin, Cellulose Acetate, Disodium Cocoamphodiacetate, Propylene Glycol, Carbomer, Sodium Hydroxide, Fragrance.

  • Package Labeling:

    Face and Body

  • INGREDIENTS AND APPEARANCE
    ACNE FACE AND BODY 
    benzoyl peroxide shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70707-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70707-101-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product12/30/2016
    2NDC:70707-101-01180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/201109/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/15/2011
    Labeler - Face Reality, Inc. (602958071)
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