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 5, 2014

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  • Active ingredient

    Benzalkonium chloride 0.10%

  • 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, glycerin, cetrimonium chloride, cocamide MEA, lauramidopropylamine oxide, myristamidopropylamine oxide, PEG-120 methyl glucose dioleate, fragrance, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, red 4

  • claims

    REFILL ONLY WITH FOAMING HAND SOAP, REGULAR LIQUID HAND SOAP WILL NOT FOAM

  • Adverse reactions

    Distributed by Harmon Stores, Inc.

    650 Liberty Ave., Union, NJ 07083 USA

    Harmon Stores, Inc.

    Visit us at: www.facevalues.com

  • Principal Display Panel

    Helps Kill

    Harmful

    Germs

    HARMON

    FACEVALUES

    Antibacterial

    FOAMING

    HAND WASH

    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:63940-641
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-641-96222 mL in 1 BOTTLE, PUMP
    2NDC:63940-641-45946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2014
    Labeler - Harmon Stores, Inc (804085293)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(63940-641)
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