Label: ZALIEX ALCOHOL-FREE ANTISEPTIC 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 September 13, 2012

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  • Zaliex Alcohol-Free Antiseptic Foam Hand Sanitizer


  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses:

    • For hand cleansing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings:

    For external use only.

    Do not use in eyes. If contact occurs, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops.

    If condition persists for more than 72 hours, consult a doctor.

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

  • Directions:

    • Pump a small amount of foam into palm of hand
    • Wet hands thoroughly with product and allow to dry without wiping.
    • Rub hands together briskly until dry
  • Inactive Ingredients:

    Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

  • Manufactured for:

    Zaliex

    Suite 210, 4 Robert Speck Parkway,

    Mississauga, Ontario, L4Z1S1, Canada

  • Zaliex Alcohol-Free Antiseptic Foam Hand Sanitizer 250ml (76452-003-00) | Zaliex Alcohol-Free Antiseptic Foam Hand Sanitizer 550ml (76452-003-01)

    ZaliexHandSanitizer250mLFrench

    ZaliexHandSanitizer550mLFrench


  • INGREDIENTS AND APPEARANCE
    ZALIEX ALCOHOL-FREE ANTISEPTIC HAND SANITIZER  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76452-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76452-003-00250 mL in 1 BOTTLE
    2NDC:76452-003-01550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/13/2012
    Labeler - SAS Healthcare Inc (248055696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Artemis Bio-Solutions Inc.963442541manufacture(76452-003)
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