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 June 28, 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

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

    water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, linalool, butylphenyl methylpropional, limonene, geraniol, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, yellow 10, green 3

  • SPL UNCLASSIFIED SECTION

    Distributed by

    Harmon Stores, Inc.

    650 Liberty Ave

    Union, NJ 07083

    Visit us at:

    www.facevalues.com

  • principal display panel

    REFILL FOR FOAMING HAND WASH DISPENSER

    Helps Kill Harmful Germs

    HARMON FACEVALUES

    Antibacterial FOAMING HAND WASH

    Gentle Enough for Daily Use

    FRESH PEAR SCENT

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.999 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    GERANIOL (UNII: L837108USY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-575-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2016
    Labeler - Harmon Stores, Inc (804085293)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63940-575)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63940-575)
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