KAY (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]

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KAY (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]
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NDC 63146-109-03, 63146-109-06, 63146-109-08, 63146-109-10
Set ID 43df5310-0302-4e6c-8e48-a35ae2d4c690
Category HUMAN OTC DRUG LABEL
Packager Kay Chemical Company
Generic Name
Product Class
Product Number
Application Number PART333E
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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 Product02/22/2008
    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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