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 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warning

    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 foam
    • 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, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

  • QUESTIONS

    Questions? call 1-866-781-8787

  • Representative Label and Principal Display Panel

    ECOLAB®

    6101091

    FACILIPRO

    Advanced Antibacterial Foaming Hand Soap

    1250 mL (42.3 FL OZ)

    Active Ingredient: Benzalkonium chloride 0.5%

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

    tel: 1 800 35 CLEAN (352 5326)

    © 2020 Ecolab USA Inc. · All rights reserved

    Made in U.S.A.

    www.ecolab.com

    Representative label

  • INGREDIENTS AND APPEARANCE
    FACILIPRO 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-566
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-566-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/23/2016
    Labeler - Ecolab Inc. (006154611)
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