Label: BIORE- salicyclic 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 13, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses •For the treatment of acne

  • WARNINGS

    Warnings

    For external use only.

    Flammable: Keep away from fire or flame

    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. 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 1 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.
  • 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, tetrasodium glutamate diacetate

  • QUESTIONS

    Questions? 1-888-BIORE-11

  • PRINCIPAL DISPLAY PANEL

    Biore

    CLEAR & BREATHABLE

    WITCH HAZEL 2% BHA TONER

    Salicylic Acid Acne Treatment

    Questions? 1-888-BIORE-11 biore.com

    BIORE is a trademark of Kao Corp.

    Distributed by Kao USA Inc.,

    Cincinnati, OH 45214 ©2022

    Made in Canada

    label

  • INGREDIENTS AND APPEARANCE
    BIORE 
    salicyclic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-196
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-196-80235 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00603/13/2023
    Labeler - KAO USA (004251617)
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