Label: BIORE CHARCOAL ACNE SCRUB- salicylic acid gel

  • NDC Code(s): 10596-184-10, 10596-184-45, 10596-184-56
  • Packager: Kao USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • SPL UNCLASSIFIED SECTION

    BIORE CHARCOAL ACNE SCRUB exfoliates away acne-causing dirt and absorbs excess oil to help eliminate breakouts.

    • 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.

    Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

  • WHEN USING

    When using this product 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 hydroxide, 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

    www.facebook.com/bioreskin

    BIORE is a trademark of Kao Corp.

    Distributed by Kao USA Inc.

    Cincinnati, OH 45214 ©2018

    Made in USA of US & Imported Ingredients

  • PRINCIPAL DISPLAY PANEL

    Biore

    free your pores!

    CHARCOAL

    GREAT FOR OILY SKIN

    scrubs out acne-causing dirt & oil

    CHARCOAL ACNE SCRUB

    SALICYLIC ACID ACNE TREATMENT

    skin purifying technology/oil-free

    acne's outta here!

    NET WT 5.63 OZ (159 g)

    10596-184 03-2021

  • INGREDIENTS AND APPEARANCE
    BIORE  CHARCOAL ACNE SCRUB
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-184
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.3 g  in 127 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)  
    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)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-184-45127 g in 1 TUBE; Type 0: Not a Combination Product12/01/201606/30/2024
    2NDC:10596-184-1028 g in 1 TUBE; Type 0: Not a Combination Product12/01/201606/30/2024
    3NDC:10596-184-56159 g in 1 TUBE; Type 0: Not a Combination Product12/01/201606/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/01/201606/30/2024
    Labeler - Kao USA Inc. (004251617)
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