Label: ZALIEX ANTISEPTIC HAND- benzalkonium chloride soap

  • 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 12, 2012

If you are a consumer or patient please visit this version.

  • Zaliex Antiseptic Foam Hand Soap


  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses:

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

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if irritation or redness develops, or 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:

    • Pump a small amount of foam into palm of hand
    • Run thoroughly over all surfaces of both hands for 15 seconds
    • Rinse with potable water
  • Inactive Ingredients:

    Water (aqua), coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide.

  • Manufactured for:

    Zaliex

    Suite 210, 4 Robert Speck Parkway,

    Mississauga, Ontario, L4Z1S1, Canada

  • Zaliex Antiseptic Foam Hand Soap 250ml | Zaliex Antiseptic Foam Hand Soap 550ml (76452-002-01) | Zaliex Antiseptic Foam Hand Soap 1000ml (76452-002-02)

    TRICLOSAN FREE


    Zaliex
    Antiseptic Foam
    HAND SOAP

    MOISTURIZES * LEAVES SKIN SOFT

    Eliminates 99.999%
    Of Most Common Germs That May Cause Illness

    8.4 fl oz (250 ml)
    Environmentally Friendly

    Zaliex250mla
    Zaliex250mlb





  • INGREDIENTS AND APPEARANCE
    ZALIEX ANTISEPTIC HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76452-002
    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)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76452-002-00250 mL in 1 BOTTLE
    2NDC:76452-002-01550 mL in 1 BOTTLE
    3NDC:76452-002-021000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/26/2011
    Labeler - SAS Healthcare Inc (248055696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Artemis Bio-Solutions Inc.963442541manufacture(76452-002)