Label: ECOLAB INC.- benzalkonium chloride solution

  • NDC Code(s): 47593-512-61, 47593-512-62
  • Packager: Ecolab Inc.
  • 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 February 4, 2020

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

  • Active ingredient

    Benzalkonium chloride 0.89%

  • Purpose

    Antispetic 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 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 Posoin Control Center right away.

  • Directions: Concentrated Solution

    • do not mix with anything except for potable water
    • use only provided bottles for dilution and dispensing of ready-to-use product
    • insert probe into bag, twist cap tight, and close dispenser
    • fill hand sanitizer bottle with solution from dispenser place bottle into a Nexa dispenser for use
  • Directions: Ready-To-Use Solution

    • wash hands to remove soil
    • apply sanitizer to hands
    • spread to cover hands thoroughly, rub to dry
  • Other information

    • for additional information, see Safety Data Sheet (SDS)
    • EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), propylene glycol, ethanol, sodium benzoate, FD&C yellow 5, FD&C red 40

  • QUESTIONS

    Questions? call 1-800-35-CLEAN (352-5326)

  • Principal Display Panel and Representative Label

    ECOLAB®     6100868

    Concentrated Foam Hand Sanitizer

    2 L (0.53 US GAL)

    Active ingredient: Benzalkonium chloride, 0.89%

    Ecolab • 370 Wabasha Stren N • St Paul MN 55102-1390 USA •

    tel: 1 800 35 CLEAN (352 5326)

    © 2014 Ecolab USA Inc • All rights reserved

    Made in the United States

    www.ecolab.com • 759248/5400/0814

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB INC. 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE8.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-512-612000 mL in 1 POUCH; Type 0: Not a Combination Product03/02/2015
    2NDC:47593-512-621300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/02/2015
    Labeler - Ecolab Inc. (006154611)