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 September 24, 2018

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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 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 product
    • 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, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquatemium-7, fragrance, potassium hydroxide, blue 1

  • QUESTIONS

    Questions? call 1-866-781-8787

  • Principal display panel and representative label

    KEYSTONE Sysco

    ADVANCED ANTIBACTERIAL LIQUID HAND SOAP

    Active Ingredient: 0.5% Benzalkonium Chloride

    Net Contents

    750 mL (25 US fl oz) 6000234

    Sysco 5287436      6101969 ECOLAB®

    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 · 773734/5400/0818

    representative label

  • INGREDIENTS AND APPEARANCE
    KEYSTONE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-594
    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
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-594-113780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/06/2018
    Labeler - Ecolab Inc. (006154611)
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