Label: EQUI-STAT- benzalkonium chloride solution

  • NDC Code(s): 47593-585-31, 47593-585-41, 47593-585-59
  • 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 October 18, 2022

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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

    NDC 47593-585-41 ECOLAB

    EQUI-STAT ™

    Antimicrobial Hand Soap

    Active Ingredient: 0.5% Benzalkonium Chloride
    Antimicrobial Handwash for Healthcare
    CHG Compatible
    Net Contents

    750 mL (25 US fl oz) 6000234

    This product may be patented | Este producto puede ser patentado: www.ecolab.com/patents

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

    © 2017 Ecolab USA Inc. · All rights reserved | Todos los derechos reservados

    Made in U.S.A. | Hecho en EE.UU.

    www.ecolab.com · 771525/8500/1017

    representative label

  • INGREDIENTS AND APPEARANCE
    EQUI-STAT 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-585
    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:47593-585-31540 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/2017
    2NDC:47593-585-591250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/2017
    3NDC:47593-585-41750 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/20/2017
    Labeler - Ecolab Inc. (006154611)
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