Label: ECOLAB- chloroxylenol solution

  • NDC Code(s): 47593-501-11, 47593-501-26, 47593-501-31, 47593-501-32, view more
    47593-501-41, 47593-501-56, 47593-501-59
  • 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 May 18, 2023

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  • Active ingredient

    Chloroxylenol 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • For handwashing to decrease bacteria on the skin
    • recommended for repeated use.
  • 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)
    • for emergency medical information in USA and Canada, call 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), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, frangrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C red #40, FD&C yellow #5, D&C red #33

  • QUESTIONS

    Questions? call 1 866 781 8787

  • Principal display panel and representative label

    NDC 47593-501-41   ECOLAB

    Medi-Stat

    Antimicrobial Hand Soap

    Healthcare Personnel Handwash

    Active Ingredient: Chloroxylenol 0.5%

    6000077

    Net Contents:

    25 US fl oz (750 mL)

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

    © 2022 Ecolab USA Inc · All rights reserved

    Made in United States

    www.ecolab.com · 755056/8501/0422

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5.20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-501-31540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2012
    2NDC:47593-501-321000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2012
    3NDC:47593-501-261000 mL in 1 POUCH; Type 0: Not a Combination Product10/25/201210/06/2024
    4NDC:47593-501-113780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2012
    5NDC:47593-501-561200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/201205/18/2023
    6NDC:47593-501-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2013
    7NDC:47593-501-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/24/2012
    Labeler - Ecolab Inc. (006154611)
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