Label: FOAMING HAND SANITIZER- 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 December 5, 2014

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  • Claims

    For questions, please visit www.mycleanpath.com or call (213) 568-0006.  Manufactured by Vi-Jon, Inc. St. Louis MO 63114

    To Dilute: Flip bottle, squeeze pod to fill measuring cup.  Remove pump, add distilled water to fill line.  Air bubble in cup is normal.  CleanPath Refill pod only to be used with CleanPath Reusable Bottle.  Do not use for any other purpose.

    effctive at eliminating 99.9% of many common harmful germs in as little as 15 seconds

  • Active ingredient

    Concentrate: Benzalkonium chloride 1.3%

    Use Dilution: Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

  • When using this product

    • do not use in the eyes.  In case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • dilute with distilled water before use because acidic or hard water may render the product inactive
  • Stop use and ask a doctor if

    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

    • follow dilution instructions
    • wet hands thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    water, DMDM hydantoin, fragrance, cetrimonium chloride, isoceteth-20, disodium cocamphodipropionate, PPG-2 hydroxyethyl coco/isostearamide, laureth-23, citric acid, blue 1, ext. violet 2, red 40

  • Adverse reaction

    Manufactured by Vi-Jon, Inc.

    St. Louis, MO 63114

  • Principal display panel

    Save Money

    FOAMING HAND SANITIZER 

    Refill Pod

    concentrate makes 3 bottles

    CleanPath

    PREMIUM

    FOAMING HAND SANITIZER

    Natural spring

    eleminated 99.9% of germs

    REDUCE WATSE

    Natural Spring

    Remove Shrink Sleeve Before Recycling

    3 FL OZ (90 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0492
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)  
    LAURETH-23 (UNII: N72LMW566G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0492-2190 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2014
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(0869-0492)
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