Label: BIORE WITCH HAZEL PORE CLARIFYING TONER- 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 28, 2023

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  • 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.

    Flammable: Keep away from fire or flame.

  • 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

    • Cleanse skin thoroughly before applying medication.
    • Cover the entire affected area with a thin layer 1 to 3 times daily using a cotton ball or pad.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • STORAGE AND HANDLING

    Other information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, alcohol denat., isopropyl alcohol, hamamelis virginiana (witch hazel) water, glycerin, polysorbate 20, sodium hydroxide, sodium citrate, alcohol, citric acid, menthol, benzophenone-4, disodium EDTA, fragrance.

  • SPL UNCLASSIFIED SECTION

    what it does:

    BIORE PORE CLARIFYING TONER teams up with Witch Hazel & Salicylic Acid. This refreshing formula helps restore skin's balance as it penetrates and deep cleans pores for clear skin.

    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

    controls oil & deep cleans for clear pores

    PORE CLARIFYING TONER

    SALICYLIC ACID ACNE TREATMENT

    lightweight/oil-free

    acne's outta here!

    NET WT 8.0 FL OZ (236 mL)

    10596-187-80-NEW

  • INGREDIENTS AND APPEARANCE
    BIORE  WITCH HAZEL PORE CLARIFYING TONER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-187
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-187-80236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/18/2018
    Labeler - Kao USA Inc. (004251617)
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