Label: BORTEK ANTIBACTERIAL HAND WASH- chloroxylenol liquid

  • NDC Code(s): 81731-508-10, 81731-508-11
  • Packager: Bortek Industries
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 26, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Chloroxylenol 0.3% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Handwash to decrease bacteria on the skin that can potentially cause disease.
    • Recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only.

    When using this product, keep away from eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation persists for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 seconds.
    • Rinse under running water and dry thoroughly.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Phenoxyethanol, Isopropyl Alcohol, Fragrance, Citric Acid, FD&C Red 4

  • SPL UNCLASSIFIED SECTION

    800.626.7835

    BortekShop.com

    Distributed by Bortek Industries, Inc., Mechanicsburg, PA 17055

  • PRINCIPAL DISPLAY PANEL

    Bortek® INDUSTRIES, INC.

    Chloroxylenol 0.3%

    ANTIBACTERIAL FOAMING HAND WASH

    33.8 FL OZ (1000 mL)

    1-Antibacterial Handsoap- 81731-508

  • INGREDIENTS AND APPEARANCE
    BORTEK ANTIBACTERIAL HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81731-508
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81731-508-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/12/202102/19/2022
    2NDC:81731-508-111000 mL in 1 POUCH; Type 0: Not a Combination Product02/19/202207/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/12/202107/20/2024
    Labeler - Bortek Industries (014184014)
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