Label: MYSTIC- benzalkonium chloride solution

  • NDC Code(s): 63146-304-03, 63146-304-10
  • 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 November 14, 2022

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  • Active Ingredient

    Benzalkonium chloride 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    • For external use only

    Do not use

    • in eyes

    When using the product

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

    Stop use and ask a docotr if

    • Skin irritation or 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

    • Wet hands and forearms
    • Dispense a palmful of product to hands
    • Scrub hands and forearms for 20 seconds
    • Rinse thoroughly and dry
  • Other information

    • for additional information, see Safety Data Sheet (SDS)
    • for emergency medical information in USA call 1-800-328-0026
  • INACTIVE INGREDIENT

    Inactive ingredients Water (Aqua), Cocamine Oxide, Hexylene Glycol, PEG-180, Glycerin, Cocamidopropyl PG-Dimonium Chloride Phosphate, Phenoxyethanol, Polyquaternium-7, Myristamide DIPA, myristamine oxide, Citric Acid, Methyl Gluceth-20, Glyceryl Caprylate/Caprate, Alcohol, PEG-12 Dimethicone, Potassium Citrate, fragrance, Blue 1

  • QUESTIONS

    Questions? Call 1-800-532-7732

  • Representative Label and Principal Display Panel

    SSDC

    Sustainable Solutions

    MYSTIC™

    Foaming Anti-Bacterial Hand Soap

    Jabón para manos con espuma antibacterial

    Benzalkonium chloride 0.5%

    1112019

    Net Content/Contenido Neto: 750mL/25 US fl. oz.

    Distributed by:

    SSDC Division, Kay Chemical Company

    4050 Corporate Drive, #100

    Grapevine, Texas 76051, USA 800.532.7732

    ©2020 Kay Chemical Company All Rights Reserved

    749431   749431/7303/0920

    Representative label

  • INGREDIENTS AND APPEARANCE
    MYSTIC 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-304-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/11/2016
    2NDC:63146-304-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/11/2016
    Labeler - Kay Chemical Company (003237021)
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