Label: QSR- chloroxylenol solution

  • NDC Code(s): 63146-110-01, 63146-110-02, 63146-110-08, 63146-110-10
  • Packager: Kay Chemical Company
  • 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 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)
    • Medical Emergency:  (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, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red #40 (CI 16035), FD&C Yellow #5 (CI 19140), D&C Red #33 (CI 17200)

  • QUESTIONS

    Questions?  Call 1-800-529-5458

  • Principal display panel and representative label

    NDC 63146-110-10         Kay

    QSR

    Antibacterial Hand Soap

    KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

    Chloroxylenol 0.5%

    Net Contents: 42 USA 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

    758210-01 • KUSA 758210/8001/0416

    representative label

  • INGREDIENTS AND APPEARANCE
    QSR 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-110
    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)  
    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/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    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:63146-110-02800 mL in 1 BAG; Type 0: Not a Combination Product12/15/2009
    2NDC:63146-110-013800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2009
    3NDC:63146-110-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2014
    4NDC:63146-110-08750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/201405/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/15/2009
    Labeler - Kay Chemical Company (003237021)
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