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QSR by Kay Chemical Company

Dosage form: solution
Ingredients: Chloroxylenol 5mg in 1mL
Labeler: Kay Chemical Company
NDC Code: 63146-110

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 Facts

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?  Call 1-800-529-5458

Principal Display Panel/Representative Label

NDC 63146-110-08

KAY

QSR

Antibacterial Hand Soap

KEEP OUT OF REACH OF CHILDREN - FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

See inside this label for complete drug facts panel.

To obtain Spanish Instructions, see outer carton.

Net contents: 25 US fl oz (750 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

758214-00 • KUSA 758214/8000/0314

QSR 
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloroxylenol (Chloroxylenol) Chloroxylenol5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POTASSIUM COCOATE 
HEXYLENE GLYCOL 
SODIUM SULFATE 
EDETATE SODIUM 
SODIUM LAURYL SULFATE 
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) 
GLYCERIN 
COCO GLUCOSIDE 
GLYCERYL OLEATE 
ANHYDROUS CITRIC ACID 
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE 
FD&C RED NO. 40 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:63146-110-02800 mL in 1 BAG
2NDC:63146-110-013800 mL in 1 BOTTLE, PLASTIC
3NDC:63146-110-101250 mL in 1 BOTTLE, PLASTIC
4NDC:63146-110-08750 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/15/2009
Labeler - Kay Chemical Company (003237021)

Revised: 01/2017
 
Kay Chemical Company

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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