Label: PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE- benzoyl peroxide soap

  • 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 23, 2020

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Microcrystalline Cellulose, Disodium, Cocoamphodiacetate, Glycerin, ethoxydiglycol, Acrylates C10-30 Alkyl Acrylates Crosspolymer, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol

  • ACTIVE INGREDIENT

    Active Ingredients: Benzoyl Peroxide 2.5%

  • PURPOSE

    Purpose: Acne Medication; a gentle medicated exfoliant wash

  • INDICATIONS & USAGE

    Uses: Treats acne and helps prevent new acne blemishes from forming, kills acne bacteria

  • WARNINGS

    WARNINGS: For External Use Only

  • DO NOT USE

    Do not use: if you have very sensitive skin; if you are sensitive to benzoyl peroxide

  • WHEN USING

    When using this product: avoid sun exposure and use sunscreen; using other acne medications at the same time may cause excessive dryness or irritation of te skin; may bleach hair and fabrics; do not use in or near eyes, lips and mouth

  • ASK DOCTOR

    Consult a doctor: if excessive irritation occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

  • DOSAGE & ADMINISTRATION

    Directions: use 1 to 3 times daily on affected areaws to help prevent breakouts; apply using fingertips, using circular motions; gently scrub into a lather; rinse off thorouhly with warm water; if going outside, use a sunscreen

  • OTHER SAFETY INFORMATION

    Other Information: store at room temperature; keep tightly closed

  • PRINCIPAL DISPLAY PANEL

    Pumice Cleansing Scrub 2.5%

  • INGREDIENTS AND APPEARANCE
    PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-004-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-004-08240 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    3NDC:70367-004-7522.18 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
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