Label: KAY- benzalkonium chloride solution

  • NDC Code(s): 63146-109-03, 63146-109-06, 63146-109-08, 63146-109-10
  • Packager: Kay Chemical Company
  • 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 July 19, 2023

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  • Active ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic handwash

  • Uses

    • For handwashing to decrease bacteria on the skin
  • Warnings

    For external use only

    Do not use

    • In eyes

    When using this product

    • if in eyes, rinse promptly and thoroughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask a doctor if

    • skin irritation and redness occurs 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

    • wash hands to remove soil
    • dispense palmful
    • spread to cover hands, rub in well
    • air dry, do not rinse or towel dry
  • Other Information

    • for additional information, see Safety Data Sheet (SDS)
    • Medical emergency:  (877) 231-2615 or call collect 0 (952) 853-1713
  • INACTIVE INGREDIENT

    Inactive ingredients  water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)

  • QUESTIONS

    Questions?  Call 1-800-529-5458

  • Principal Display panel and representative label

    NDC 63146-109-10

    KAY

    Foaming Hand Sanitizer

    KEEP OUT OF REACH OF CHILDREN - FOR INSTITUTIONAL USE ONLY

    Benzalkonium chloride 0.1%

    Net contents: 42 US fl oz (1250 ml)

    Distributed by:

    Kay Chemical Company • 8300 Capital Drive

    Greensboro, NC 27409-9790  USA

    Customer Service: (800) 529-5458

    ©2018 Kay Chemical Company

    All rights reserved

    757547-02 • KUSA 757547/8002/0618

    representative label

  • INGREDIENTS AND APPEARANCE
    KAY 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-109
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-109-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/200805/02/2022
    2NDC:63146-109-061200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/22/2011
    3NDC:63146-109-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2014
    4NDC:63146-109-08750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/201405/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/22/2008
    Labeler - Kay Chemical Company (003237021)
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