Label: KEYSTONE- benzalkonium chloride solution

  • 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 June 6, 2019

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  • Active Ingredient

    Benzalkonium chloride 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warning

    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 doctor 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 apply foam
    • scrub hands and forearms
    • rinse thoroughly and dry
  • Other information

    • for additional information, see Safety Data Sheet (SDS)
    • for emergency medical information, in USA and Canada, 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 1 866 781 8787

  • Representative Label and Principal Display Panel

    KEYSTONE™

    Sysco®

    Advanced Antibacterial Foaming Hand Soap

    Active Ingredient: Benzalkonium chloride 0.5%

    Sysco® 4596843 6101146 ECOLAB®

    750 mL (25.3 US FL OZ) 764502/5401/0918

    This product may be patented: www.ecolab.com/patents

    For SDS information visit:

    www.cleanwithkeystone.com

    Ecolab · 1 Ecolab Place · St Paul MN 55102 USA ·

    tel: 1 800 35 CLEAN (352 5326)

    © 2018 Ecolab USA Inc. · All rights reserved

    Made in U.S.A.

    www.ecolab.com

    Representative label

  • INGREDIENTS AND APPEARANCE
    KEYSTONE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-561
    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
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9)  
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-561-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2016
    Labeler - Ecolab Inc. (006154611)
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