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

  • NDC Code(s): 70707-711-06
  • Packager: Face Reality Skin Care, LLC
  • 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 January 4, 2017

If you are a consumer or patient please visit this version.

  • 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, Disodium Cocoamphodiacetate, Propylene Glycol, Carbomer, Sodium Hydroxide, Fragrance.

  • Package Labeling:

    Acne Face 01

  • INGREDIENTS AND APPEARANCE
    ACNE FACE AND BODY WASH 
    benzoyl peroxide shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70707-711
    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)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70707-711-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product12/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/31/2016
    Labeler - Face Reality Skin Care, LLC (602958071)