Fortress (Chloroxylenol) Solution [Kay Chemical Co.] -

FORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]
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NDC	63146-105-03
Set ID	ebf6ee92-29fc-4923-a518-3f6d3ceec7cc
Category	HUMAN OTC DRUG LABEL
Packager	Kay Chemical Co.
Generic Name
Product Class
Product Number
Application Number	PART333E

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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 hands and forearms
- Dispense a palmful of product to hands
- Scrub hands and forearms for 20 seconds
- Rinse thoroughly and dry
Other Information
- for additional information, see Material Safety Data Sheet (MSDS)
- for emergency medical information in USA, call (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, methychloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)
QUESTIONS

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

INGREDIENTS AND APPEARANCE

FORTRESS
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63146-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63146-105-03	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/16/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/16/2005

Labeler - Kay Chemical Co. (003237021)

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Medic

FORTRESS (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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