Label: ECOLAB INC.- 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 July 18, 2023

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

View All Sections
  • Active ingredient

    Benzalkonium chloride 0.89%

  • 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: Concentrated Solution

    • do not mix with anything except for potable water
    • use only provided bottles for diution and dispensing of ready-to-use product
    • remove cap, open dispenser door, place bottle into position, and close dispenser door
    • fill hand soap bottle with solution from dispenser
    • place bottle into a Nexa or Syncra dispenser for use
  • Directions: Ready-To-Use Solution

    • wet hands with warm water
    • apply soap to hands and scrub vigorously
    • wash between fingers, around fingernails, and back of hands
    • rinse hands thoroughly with warm water
    • dry hands with clean towel or with mechanical dryer
  • 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 in the US).
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), cocamine oxide, glycerin, cocamidopropyl PG-dimonium chloride phosphate, hexylene glycol, methyl gluceth-20, PEG 7 glyceryl cocoate, potlyquaternium-77, polyquaternium-7, tetrasodium EDTA, PEG-12 dimethicone, lactic acid, glyceth-18 ethylhexanoate, ethanol, magnesium nitrate, fragrance, glycereth-18, methylchloroisothiazolinone, magnesium chloride, DC red 33, mehtylisothiazolinone

  • QUESTIONS

    Questions? call 1800-35-CLEAN (352-5326)

  • Principal Display Panel and Representative Label

    ECOLAB®   6100872

    FACILIPRO

    Concentrated Antibacterial Foaming Hand Soap

    1.3L (44 US FL OZ)

    Active Ingredient: Benzalkonium chloride, 0.89%

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

    tel: 1 800 35 CLEAN (352 5326)

    © 2021 Ecolab USA Inc. · All rights reserved

    Made in U.S.A.

    759257/5402/0121

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB INC. 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-513
    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)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    GLYCERETH-18 (UNII: SA5E43C17C)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-513-621300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/26/2015
    Labeler - Ecolab Inc. (006154611)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!