Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride solution

  • Category: HUMAN OTC DRUG LABEL

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 March 7, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

    Benzalkonium Chloride 0.13% Purpose Antiseptic

  • Drug Facts

    Antiseptic

  • Drug Facts

    For personal hand sanitizing and to reduce bacteria on the skin. Recommended for repeated use

    Avoid contact with eyes. In the case of eye contact flush eyes with water.

  • Warnings

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

  • Ask Doctor

    Stop use and ask a doctor if irritation and redness develop

  • Inactive ingredients

    Fragrances, water

  • Directions

    Apply liberally to the hands and gently rub until dry

  • Questions?

    Telephone: 44-1639-898150 Monday through Friday 8:00am til 4:30pm UK time

  • Keep out of reach of children

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

  • Package quantity

    Gwalia Hybrisan 100ml Hand Sanitizer Bottle Front viewGwalia Hybrisan 100ml Hand Sanitizer Bottle Back viewGwalia Hybrisan 100ml Hand Sanitizer Label100ml (3.38 Floz) NDC 81685-321-10

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81685-321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    3A,4,5,6,7,7A-HEXAHYDRO-1H-4,7-METHANOINDEN-6-YL ACETATE (UNII: 5232EN3X2F)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .ALPHA.-TERPINEOL (UNII: 21334LVV8W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    Product Characteristics
    Coloryellow (Clear liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81685-321-10100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2021
    Labeler - Hybrisan Ltd (219599200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hybrisan Ltd219599200manufacture(81685-321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gwalia Healthcare Limited220632253pack(81685-321)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!