Label: HAND SANITIZER- benzalkonium chloride spray

  • 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 January 17, 2022

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  • ACTIVE INGREDIENTS

    BENZALKONIUM CHLORIDE 0.1%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • HAND SANITIZING TO ALLEVIATE 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 EYES 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

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    SPRAY SMALL AMOUNT ON HANDS, SKIN OR SURFACES. RUB AND LET DRY THOROUGHLY.

  • INACTIVE INGREDIENTS

    WATER, CETRIMONIUM CHLORIDE, LAURTRIMONIUM CHLORIDE, DIHYDROXYETHYL COCAMINE OXIDE, GLYCERETH-17 COCOATE, CITRIC ACID, FRAGRANCE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_G-Tech Armour_front

    01b LBL_G-Tech Armour_Drug Facts Box

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73135-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73135-102-1160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/04/2020
    2NDC:73135-102-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    3NDC:73135-102-13240 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    4NDC:73135-102-14480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    5NDC:73135-102-15960 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    6NDC:73135-102-163785 mL in 1 JUG; Type 0: Not a Combination Product11/04/2020
    7NDC:73135-102-1718927 mL in 1 CONTAINER; Type 0: Not a Combination Product11/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/04/2020
    Labeler - G Tech Sport (015395537)
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