Label: ECOLAB- chloroxylenol 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 August 30, 2018

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  • Active ingredient

    Chloroxylenol 0.5%

  • 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 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 forearms. • Apply palmful to hands and forearms.
    • Scrub thoroughly. • Rinse and dry.
  • Other information

    • for additional information, see Safety Data Sheet (SDS)
    • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methylchloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FD&C Red. No. 4)

  • QUESTIONS

    Questions? Call 1-800-529-5458

  • Representative Label and Principal Display Panel

    ECOLAB® 

    Peel Here For Drug Facts

    NDC 63146-124-10

    Foaming Antibacterial
    Hand Soap
    Jabón de manos
    antibacterial en espuma

    Foaming Antibacterial Hand Soap is a rich lather hand soap with
    a balanced blend of cleaning agents and skin protecting moisturizers.

    KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY
    Chloroxylenol 0.5%

    To obtain Spanish Instructions, see outer carton.
    Para obtener las instrucciones en español, véase la caja exterior.

    Net contents: 42 US fl oz (1250 ml)

    Distributed by:
    Kay Chemical Company · 8300 Capital Drive
    Greensboro, NC 27409-9790 USA
    Customer Service: (800) 529-5458
    ©2016 Kay Chemical Company · All rights reserved
    764645-00 · FRSUSA 764645/8000/0116

    representative label

  • INGREDIENTS AND APPEARANCE
    ECOLAB 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-124
    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 ANHYDROUS (UNII: 36KCS0R750)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    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:63146-124-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/30/2015
    Labeler - Kay Chemical Company (003237021)
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