Label: PUREFORCE- benzalkonium chloride solution

  • NDC Code(s): 47593-567-30, 47593-567-41, 47593-567-59
  • 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 July 12, 2023

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  • 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 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

    • 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)
    • 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, propylene glycol, isopropyl alcohol, FD&C red 40, FD&C blue 1

  • QUESTIONS

    Questions? call 1-866-444-7450

  • Principal Display Panel and Representative Label

    Foodservice Foaming

    Hand Sanitizer

    Hand Care

    Active ingredient: Benzalkonium Chloride 0.1%

    Product No.

    8000340

    42.3 US FL OZ (1250 mL)

    766499/5401/1020

    For questions or comments,

    call 1-866-444-7450.

    Distributed by
    Ecolab

    1 Ecolab Place

    St Paul MN 55102 USA

    © 2020 Ecolab USA Inc

    All rights reserved

    Made in U.S.A.

    representative label

  • INGREDIENTS AND APPEARANCE
    PUREFORCE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-567
    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:47593-567-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/2016
    2NDC:47593-567-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/2016
    3NDC:47593-567-30207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/201607/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/14/2016
    Labeler - Ecolab Inc. (006154611)
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