FORTRESS- chloroxylenol solution 
Kay Chemical Co.

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

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, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methychloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Questions?  Call 1-800-529-5458

Principal display panel and representative label

FORTRESS® Foaming Antibacterial Hand Soap

KEEP OUT OF REACH OF CHILDREN/FOR INSTITUTIONAL USE ONLY

FORTRESS® Foaming Antibacterial Hand Soap is a rich lather hand soap with a balanced blend of cleaning agents and skin protecting moisturizers.

To obtain Spanish instructions, see outer carton.

Para obtener las instrucciones en español, véase la caja exterior.

NDC.: 63146-105-03

KAY CHEMICAL COMPANY

8300 Capital Drive

Greensboro, NC 27409-3790, USA

Customer Service: (800) 529-5458

706402-04

KUSA 706402/8004/0412

©2012 Kay Chemical Company

All Rights Reserved

25 US fl OZ (750 ml)

representative label

FORTRESS 
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-105
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)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63146-105-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/16/2005
Labeler - Kay Chemical Co. (003237021)

Revised: 11/2022
Document Id: 535d840e-ac85-4a48-b489-462982efba1d
Set id: ebf6ee92-29fc-4923-a518-3f6d3ceec7cc
Version: 4
Effective Time: 20221111
 
Kay Chemical Co.