FACILIPRO (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]

FACILIPRO (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]
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NDC 47593-566-59
Set ID 59580c40-ca37-4ac9-a2c3-ea86197cf68c
Category HUMAN OTC DRUG LABEL
Packager Ecolab Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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 physician 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

    Jabón antibacterial avanzada espuma mano

    1250 mL (42.3 FL OZ)

    Ecolab · 370 Wabasha Street N · St Paul MN 55102-1390 USA ·
    tel: 1 800 35 CLEAN (352 5326)
    © 2015 Ecolab USA Inc. · All rights reserved | Todos los
    derechos reservados
    Made in United States | Hecho en Estados Unidos
    www.ecolab.com · 763130/5400/1115

    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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