MYSTIC FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]

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MYSTIC FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]
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NDC 63146-117-03, 63146-117-10
Set ID 229a1d8d-8ece-492f-a296-295ce075a4c1
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 or redness occurs 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

    • 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 Material Safety Data Sheet (MSDS)
    • for emergency medical information in USA call 1-800-391-1504
  • INACTIVE INGREDIENT

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

  • Questions?

    Call 1-800-532-7732

  • Representative label and principal display panel

    SSDC

    NDC 63146-117-03

    MYSTIC

    Foaming Hand Sanitizer

    Benzalkonium chloride 0.1%

    Net Contents: 750 mL/25 US fl oz

    Distributed by:  SSDC Division, Kay Chemical Company

    4050 Corporate Drive, #100

    Grapevine, Texas 76051, USA 800.532.7732

    Copyright, 2010 Kay Chemical Company  All Rights Reserved

    749436-01 - 749436/7301/0715

    1112021

    representative label

  • INGREDIENTS AND APPEARANCE
    MYSTIC FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-117
    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:63146-117-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2010
    2NDC:63146-117-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/29/2010
    Labeler - Kay Chemical Company (003237021)
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