Label: FACILIPRO- ethyl alcohol 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 October 13, 2022

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  • Active ingredient

    Ethyl alcohol, 62% w/w

  • Purpose

    Antiseptic handwash

  • Uses

    • For hand washing to decrease bacteria on the skin
  • Warnings

    For external use only
    Flammable, keep away from fire or flame, heat, sparks and sources of static discharge.

    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 and redness persist 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

    • wash hands to remove soil
    • dispense palmful
    • spread to cover hands, rub in well
    • air dry, do not rinse or towel dry
  • Other information

    • for additional information, see Material Safety Data Sheet (MSDS)
    • 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 ingredeints  water (aqua), PEG-10 dimethicone, ethylhexylglycerin, farnesol, bisabolol, tert-butyl alcohol, dentonium benzoate

  • QUESTIONS

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

  • Principal Display Panel and Representative label

    ECOLAB®

    6100781

    FACILIPRO™

    Waterless Foam Hand Sanitizer

    Sanitizante en espuma sin agua para manos

    1200 mL (40.6 US FL OZ)

    Active Ingredient:

    Ethyl alcohol 62% w/w

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

    © 2020  Ecolab USA Inc. · All rights reserved | Todos los derechos reservados

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

    www.ecolab.com

    SDS-WI-15014, SDS-NJ-20007

    representative label

  • INGREDIENTS AND APPEARANCE
    FACILIPRO  
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FARNESOL (UNII: EB41QIU6JL)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-563-561200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/03/2010
    Labeler - Ecolab Inc. (006154611)
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