Label: HAND WASH- benzalkonium chloride liquid

  • 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 July 8, 2022

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition 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.

  • Directions

    • apply palmful to dry hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, glycerin, lauramine oxide, cocamidopropyl betaine, PEG-150 distearate, cocamide MEA, fragrance, citric acid, tetrasodium EDTA, DMDM hydantoin, benzophenone-4, blue 1, red 33

  • adverse reaction

    PERMATEX and design are TMs of Illinois Tool Works, Inc. 2016 Permatex, a division of ITW.

    Solon, OH 44139/  Assembled in U.S.A. with U.S. and global materials

    www.permatex. com Item # 95105

    743.000/743AA

  • principal display panel

    FAST ORANGE

    Antibacterial FOAMING HAND WASH

    FRESH SCENT!

    Helps kill harmful germs

    Gentle enough for everyday use

    7.5 FL OZ (221 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70616-743
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3091 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70616-743-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2016
    Labeler - Permatex (964477025)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(70616-743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(70616-743)
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