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 May 18, 2017

If you are a consumer or patient please visit this version.

  • 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 throughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask doctor if skin irritation or redness persists 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

    • 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 worldwide, call 1 800 328 0026
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, FD&C blue 1

  • QUESTIONS

    Questions? call 1 800 781 8787

  • Representative label and principal display panel

    NDC 47593-581-41

    ECOLAB

    Special Care

    Foam Hand Sanitizer

    Active Ingredient:  Benzalkonium chloride 0.1%

    CHG Compatible

    Net Contents

    25 fl oz (750 mL)

    This product may be patented:

    www.ecolab.com/patents

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 866 781 8787

    © 2016 Ecolab USA Inc. · All rights reserved

    Made in United States

    769816/8500/1116

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-581
    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:47593-581-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2017
    Labeler - Ecolab Inc. (006154611)