Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride aerosol, foam

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 7, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose

    Benzalkonium Chloride 0.13percent......Antimicrobial

  • PURPOSE

    Use: To decrease bacterial on the skin that could cause disease.  Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

    Avoid contact with eyes.  In case of contact with eyes, flush thoroughly with water.

  • STOP USE

    Stop use and ask doctor if skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    For adults and children 2 yrs. and older.  Apply a thumbnail size amount on palms and rub hands thoroughly until dry.

  • STORAGE AND HANDLING

    Other Information:

    Do not freeze.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cocamidopropyl Betaine, Propylene Glycol, Glycerine, Citric Acid, Cocamidopropylamine Oxide, Triethanolamine (TEA)

  • DEPENDENCE


    Distributed by Tekweld Inc.
    180 Central Avenue
    FARMINGDALE, NY 11735

    Made in China

  • PRINCIPAL DISPLAY PANEL

    ALCOHOL FREE

    Hand Sanitizer

    Kills 99.99 percent of Germs Instantly!

    Safer for kids, Non-dry to hands, Non flammable

  • PRINCIPAL DISPLAY PANEL

    AlcoholFreeHandSanitizer

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31190-100-6060 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/07/2010
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture