QSR- chloroxylenol solution 
Kay Chemical Company

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.

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Drug Facts

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antiseptic handwash

Uses

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

Other Information

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 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

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)

Revised: 7/2022
Document Id: 4cf546dc-9fca-49f8-a557-46a319a3bbff
Set id: 9d6c9904-d8aa-46c8-b857-6372885f1d19
Version: 3
Effective Time: 20220726
 
Kay Chemical Company