Label: ECOLAB- chloroxylenol liquid

  • NDC Code(s): 47593-506-41, 47593-506-59
  • Packager: Ecolab Inc.
  • 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 21, 2022

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  • Active ingredient

    Chloroxylenol 1.0%

  • 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 for 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 forearm
    • 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 (aqua), propylene glycol, urea, sorbitol, potassium cocoate, tetrasodium EDTA, SD alcohol 3-C, glycerin, sodium xylenesulfonate, citric acid, fragrance, cocamine oxide, FDC yellow 5, FDC blue 1

  • QUESTIONS

    Questions? call 1.800.35.CLEAN (352.5326)

  • Principal Display Panel and Representative Label

    ECOLAB®

    6100719

    Gentle Antibacterial

    Foam Hand Soap

    750 ML (25 US FL OZ)

    Active ingredient: Chloroxylenol 1.0%

    755511/5401/0120

    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

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    UREA (UNII: 8W8T17847W)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-506-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2014
    2NDC:47593-506-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/21/2014
    Labeler - Ecolab Inc. (006154611)
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