PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [ONLY YOURX, INC.]

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PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [ONLY YOURX, INC.]
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NDC 70367-004-04, 70367-004-08, 70367-004-75
Set ID 270814fa-0109-6262-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Only Yourx, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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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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