Label: QSR- chloroxyenol solution

  • NDC Code(s): 63146-111-03, 63146-111-08, 63146-111-10
  • 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 May 19, 2023

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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 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

  • Principal Display Panel/Representative Label

    NDC 63146-111-10

    Kay

    QSR

    Foaming Antibacterial Hand Soap

    Instant foam lathers fast • Mild, pH-balanced formula • Fresh, clean fragrance

    QSR 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%

    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
    ©2014 Kay Chemical Company | All rights reserved
    756220-01 • KUSA 756220/8001/0214

    Representative Label

  • INGREDIENTS AND APPEARANCE
    QSR 
    chloroxyenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-111
    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)  
    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:63146-111-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2010
    2NDC:63146-111-08750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/201305/19/2023
    3NDC:63146-111-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/22/2010
    Labeler - Kay Chemical Company (003237021)
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