Label: BIORE MENS CHARCOAL ACNE SCRUB- salicylic acid gel

  • 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 September 29, 2019

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  • SPL UNCLASSIFIED SECTION

    BIORE CHARCOAL ACNE CLEARING SCRUB cleans and exfoliates away acne-causing dirt and absorbs excess oil to help eliminate breakouts for clear skin.

    • with Natural Charcoal
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 1%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    • clears up acne blemishes
    • penetrates pores to control acne blemishes
    • helps prevent new acne blemishes from forming
  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    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 acne medication at a time.
    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • wet face
    • squeeze product into hands
    • massage over entire face
    • rinse thoroughly
    • for optimal results, use up to 2-3 times per week
  • STORAGE AND HANDLING

    Other information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Glycerin, Sodium Laureth Sulfate, Alumina, Cocamidopropyl Betaine, Sorbitol, Laureth-4 Carboxylic Acid, Synthetic Wax, Microcrystalline Wax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance, Sodium Hdroxide, Menthol, Polyquaternium-39, Charcoal Powder, Disodium EDTA, Talc, Sodium Benzoate,Red 30, Yellow 5 lake

  • SPL UNCLASSIFIED SECTION

    Questions? 1-888-BIORE-11

    www.biore.com @bioreus

    BIORE is a trademark of Kao Corp.

    Distributed by Kao USA Inc.

    Cincinnati, OH 45214 ©2019

    Made in USA of US & Imported Ingredients

  • PRINCIPAL DISPLAY PANEL

    Biore

    free your pores!

    MEN'S SKINCARE

    CHARCOAL ACNE CLEARING SCRUB

    scrubs out acne-causing dirt & oil

    SALICYLIC ACID ACNE TREATMENT

    NET WT 4.5 OZ (127 g)

    10596-192-45-NEW

  • INGREDIENTS AND APPEARANCE
    BIORE  MENS CHARCOAL ACNE SCRUB
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALUMINUM (UNII: CPD4NFA903)  
    POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TALC (UNII: 7SEV7J4R1U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SORBITOL (UNII: 506T60A25R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-192-45127 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2019
    Labeler - Kao USA Inc. (004251617)
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