Label: BIORE WITCH HAZEL PORE CLARIFYING CLEANSER- salicylic acid liquid

  • 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 March 16, 2021

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  • SPL UNCLASSIFIED SECTION

    BIORE PORE CLARIFYING COOLING CLEANSER

    This refreshingly cool formula works to deep clean by removing over 99% of blemish causing dirt and oil.

    • With Witch Hazel, known to tighten pores, purify, and refresh skin
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • 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 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, glycerin, sodium C14-16 olefin sulfonate, sodium laureth sulfate, coco-glucoside, cocamidopropyl betaine, betaine, lauric acid, PEG-7 glyceryl cocoate, glyceryl oleate, sodium hydroxide, fragrance, menthol, polyquaternium-7, BHT, disodium EDTA, hamamelis virginiana (witch hazel) water, eucalyptus globulus leaf extract, lavandula angustifolia (lavender) flower extract, alcohol

  • 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!

    WITCH HAZEL

    deep cleans, clarifies and refines pores

    PORE CLARIFYING COOLING CLEANSER

    SALICYLIC ACID ACNE TREATMENT

    oil-free

    acne's outta here!

    6.77 FL OZ (200 mL)

    10596-188 03-2021

  • INGREDIENTS AND APPEARANCE
    BIORE  WITCH HAZEL PORE CLARIFYING CLEANSER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHOL (UNII: L7T10EIP3A)  
    BETAINE (UNII: 3SCV180C9W)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-188-67200 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2018
    Labeler - Kao USA Inc. (004251617)
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