QSR- chloroxylenol solution

QSR by

Drug Labeling and Warnings

QSR by is a Otc medication manufactured, distributed, or labeled by Kay Chemical Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/15/2009

Labeler - Kay Chemical Company (003237021)