Label: ECOLAB INC.- chloroxylenol liquid

  • NDC Code(s): 47593-503-41, 47593-503-59
  • 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 June 28, 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 infomration 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, glycerin, sodium citrate, glyceryl oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, lauryl glucoside, magnesium nitrate, sodium hydroxide, methylchloroisothiazolinone, magnesium chloride, yellow 5, methylisothiazolinone, red 4

  • QUESTIONS

    Questions?  call 1 866 781 8787

  • Principal display panel and representative label

    NDC 47593-503-59

    ECOLAB

    MEDI-STAT® Foam

    Antimicrobial Hand Soap

    Active Ingredient:  Chloroxylenol 0.5%

    Net Contents:  1250 mL (42.3 fl oz)

    6000107

    Ecolab · 1 Ecolab Place · St Paul MN 55102 USA

    © 2022 Ecolab USA Inc · All rights reserved

    Made in United States

    755670/8502/0422

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB INC. 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    SODIUM GLYCOLATE (UNII: B75E535IMI)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-503-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2013
    2NDC:47593-503-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/27/2013
    Labeler - Ecolab Inc. (006154611)
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