Qsr (Chloroxylenol) Solution [Kay Chemical Company] -

QSR (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL COMPANY]
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NDC	63146-110-01, 63146-110-02, 63146-110-08, 63146-110-10
Set ID	9d6c9904-d8aa-46c8-b857-6372885f1d19
Category	HUMAN OTC DRUG LABEL
Packager	Kay Chemical Company
Generic Name
Product Class
Product Number
Application Number	PART333

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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 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

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

INGREDIENTS AND APPEARANCE

QSR
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63146-110
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)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63146-110-02	800 mL in 1 BAG; Type 0: Not a Combination Product	12/15/2009
2	NDC:63146-110-01	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2009
3	NDC:63146-110-10	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2014
4	NDC:63146-110-08	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/15/2009

Labeler - Kay Chemical Company (003237021)

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Medic

Do not use

When using this product

Stop use and ask a doctor if