Label: BIORE DAILY DETOX ACNE 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 June 25, 2020

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  • SPL UNCLASSIFIED SECTION

    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

    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 product
    • 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.
  • STORAGE AND HANDLING

    Other informationstore at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredientsWater, Alcohol Denat., Isopropyl Alcohol, PEG-7 Glyceryl Cocoate, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Polysorbate 20, Sodium hydroxide, Sodium Citrate, Alcohol, Citric Acid, Menthol, Benzophenonone-4, Disodium EDTA, Fragrance, Cannabis Sativa (Hemp) Seed Oil, Propylene Glycol, Camelia Sinensis Leaf Extract.

  • 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 ©2020
    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    Biore

    free your pores!

    DAILY DETOX

    ORGANIC CANNABIS SATIVA SEED OIL & GREEN TEA EXTRACT

    helps prevent breakouts and keep skin clear

    TONER

    great for blemish prone skin

    8 FL OZ (236 mL)

    10596-193-80-NEW-FINAL

  • INGREDIENTS AND APPEARANCE
    BIORE  DAILY DETOX ACNE TONER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-193
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-193-80236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2020
    Labeler - Kao USA Inc. (004251617)
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