Label: BIORE CHARCOAL ACNE CLEARING CLEANSER- salicylic acid gel

  • NDC Code(s): 10596-185-11, 10596-185-50, 10596-185-67, 10596-185-85
  • Packager: Kao USA Inc.
  • 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 October 2, 2020

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  • SPL UNCLASSIFIED SECTION

    BIORE CHARCOAL ACNE CLEARING CLEANSER

    deep cleans, penetrates pores and absorbs oil to help stop 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.

  • 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 this occurs, only use one topical 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
    • pump product into hands
    • massage over entire face and neck
    • rinse thoroughly
    • for optimal results, use daily
  • STORAGE AND HANDLING

    Other information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, sodium laureth sulfate, cocamidopropyl betaine, sorbitol, glycerin, laureth-4 carboxylic acid, ethyhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, sodium benzoate, fragrance, menthol, sodium hydroxide, polyquaternium-39, disodium EDTA, charcoal powder

  • SPL UNCLASSIFIED SECTION

    Questions? 1-888-BIORE-11

    www.biore.com

    BIORE is a trademark of Kao Corp.

    Distributed by Kao USA Inc.

    Cincinnati, OH 45214

    ©2018

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    Biore

    free your pores!

    CHARCOAL

    GREAT FOR OILY SKIN

    absorbs oil and clears breakouts

    CHARCOAL ACNE CLEARING CLEANSER

    SALICYLIC ACID ACNE TREATMENT

    skin purifying technology/oil-free

    acne's outta here!

    NET WT 11.45 FL. OZ. (338 mL)

    19596-185-11- NEW SIZE

  • INGREDIENTS AND APPEARANCE
    BIORE  CHARCOAL ACNE CLEARING CLEANSER
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SORBITOL (UNII: 506T60A25R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-185-85250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2016
    2NDC:10596-185-67200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2016
    3NDC:10596-185-11338 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/09/2018
    4NDC:10596-185-50147 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2016
    Labeler - Kao USA Inc. (004251617)
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