Label: FACILIPRO- 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, 2023

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  • Active ingredient

    Benzalkonium Chloride 0.55%

  • 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

    • wet skin and spread a small amount on hands and forearms
    • scrub well, rinse thoroughly and 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, hexylene glycol, cocamine oxide, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, phenoxyethanol, myristamide DIPA, caprylic/capric glycerides, citric acid, hydroxypropyl guar hydroxypypropyltrimonium chloride, PEG-12 dimethicone, ethanol, tocopheryl acetate, fragrance, potassium hydroxide

  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), hexylene glycol, cocamine oxide, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, phenoxyethanol, myristamide DIPA, caprylic/capric glycerides, citric acid, hydroxypropyl guar hydroxypypropyltrimonium chloride, PEG-12 dimethicone, ethanol, tocopheryl acetate, fragrance, potassium hydroxide

  • QUESTIONS

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

  • Principal Display Panel and representative label

    ECOLAB

    6100960

    FACILIPRO

    Premium Antibacterial

    Foam Hand Soap

    1250 mL (42.3 US FL OZ)

    Active ingredient: Benzalkonium Chloride 0.55%

    761097/5402/0321

    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.

    www.gofacilipro.com

    representative label

  • INGREDIENTS AND APPEARANCE
    FACILIPRO 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-565
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    glycerin (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-565-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/29/2016
    Labeler - Ecolab Inc. (006154611)
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