Label: ECOLAB- 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 October 26, 2022

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  • Active ingredient

    Benzalkonium Chloride, 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use.

  • 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet skin and spread a small amount around on hands and forearms
    • scrub well, 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 ingredients

    water (aqua), laurtrimonium chloride, hexylene glycol, PEG-5 propylhepyl ether, capryloyl/caproyl methyl glucamide, cocamidopropyl PG-dimonium chloride phosphate, histidine, propylene glycol, phenoxyethanol, glycerin, palmitamidopropyltrimonium chloride, methyl gluceth-20, trisodium dicarboxymethyl alaninate, hydroxyethylcellulose, citric acid

  • QUESTIONS

    Questions? call 1 866 781 8787

  • Prinicpal Display Panel / Representative Label

    Ecolab Antimicrobial Foaming Hand Wash

    Active Ingredient: 0.5% Benzalkonium Chloride
    Net Contents: 750 mL (25 fl oz)

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

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA
    © 2017 Ecolab USA Inc. · All rights reserved
    Made in United States
    www.ecolab.com

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-613
    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)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PEG-5 PROPYLHEPTYL ETHER (UNII: B14N5T2HEY)  
    CAPRYLOYL/CAPROYL METHYL GLUCAMIDE (UNII: 0451R360HR)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    HISTIDINE (UNII: 4QD397987E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    TRISODIUM DICARBOXYMETHYL ALANINATE (UNII: 784K2O81WY)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-613-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/19/2019
    Labeler - Ecolab Inc. (006154611)
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