Label: HAND SANITIZER- benzalkonium chloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Inactive Ingredients

    Cyclopentasiloxane, Dimethacone, Crosspolymer, PPG-3, Benzyl Ether Ethylhexanoate, Octadecyldimethyl Trimethoxysilylpropyl Ammonium Chloride.

  • USES

    For Hand Sanitizing.

  • DIRECTIONS

    Prime pump, use one pump to cover both hands.

  • WARNINGS

    The Human Corona Virus is not COVID-19. For External Use Only. Avoid contacts with eyes. In case of eye contact, flush eyes with water. If irritation or redness develops, stop use. If condition persists for more than 72 hours, contact a doctor.

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

  • SPL UNCLASSIFIED SECTION

    Distributed By: Thor Microbials

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Label

    Si + ARMOR
    LONG-LASTING ANTIMICROBIAL

    HAND SANITIZER

    ALCOHOL FREE

    KILLS 99.9% OF GERMS &
    HUMAN CORONA VIRUS

    4-8 HOURS
    OF GERM PROTECTION

    Softens Hands • 200 Applications
    1 fl oz ( 30 ml)

    • MADE IN •
    • USA •

    Principal Display Panel - 30 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80581-087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIPROPYLENE GLYCOL (UNII: 3C8845E7C1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80581-087-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00309/21/2020
    Labeler - QuadSil Inc (168969595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri Pac020844956MANUFACTURE(80581-087)
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