Label: MYSTIC FOAMING HAND SANITIZER- benzalkonium chloride solution

  • NDC Code(s): 63146-117-03, 63146-117-10
  • 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 May 22, 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 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 Safety Data Sheet (SDS)
    • 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

    NDC 63146-117-10

    MYSTIC

    Foaming Hand Sanitizer

    Benzalkonium chloride 0.1%

    Net Contents: 1250 mL/42.3 US fl oz

    Distributed by:  SSDC Division, Kay Chemical Company

    4050 Corporate Drive, #100

    Grapevine, Texas 76051, USA 800.532.7732

    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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