Label: KAY MCD- 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 July 26, 2022

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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 and 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 5 ml (teaspoonful) or palmful to hands and forearms.
    • Scrub thoroughly for 20 seconds.
    • Rinse and repeat.
  • Other information

    • For additional information, see Material Safety Data Sheet (MSDS)
    • For emergency medical information in USA call (877) 231-2615 or call collect 0 (952)853-1713.
  • Inactive ingredients

    water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerine, coco glucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red 40, FD&C Yellow 5, D&C Red 33.

  • Questions?

    Call 1-800-529-5458

  • Principal Display Panel - Representative Label

    NDC No.: 63146-102-01

    McD

    Anti-Microbial

    Handwash (AMH)

    FOR INSTITUTIONAL USE ONLY

    (Chloroxylenol 0.5%)

    1 US gal (3.8L)

    ECOLAB

    KAY CHEMICAL COMPANY - 8300 Capital Drive - Greensboro, NC 27409-9790 USA

    Customer Service: (800) 529-5458

    Made in USA

    Representative label

  • INGREDIENTS AND APPEARANCE
    KAY MCD 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 mg  in 100 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)  
    HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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:63146-102-013800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/13/2005
    Labeler - Kay Chemical Company (003237021)
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