Ecolab (Chloroxylenol) Solution [Ecolab Inc.] -

ECOLAB (CHLOROXYLENOL) SOLUTION [ECOLAB INC.]
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NDC	47593-501-11, 47593-501-26, 47593-501-31, 47593-501-32, 47593-501-41, 47593-501-56, 47593-501-59
Set ID	b4493ad6-e1c8-4b2d-8a57-1845589b04f9
Category	HUMAN OTC DRUG LABEL
Packager	Ecolab Inc.
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 skin and spread a small amount on hands and forearms
- Scrub well, rinse thoroughly and dry
Other information
- Read Material Safety Data Sheet (MSDS) before using this product
- Emergency Healthcare Information: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
INACTIVE INGREDIENT

Inactive ingredients water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, frangrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C red #40, FD&C yellow #5, D&C red #33
QUESTIONS

Questions? call 1 800 781 8787
Principal Display Panel and Representative Label

ECOLAB

NDC 47593-501-31

MEDI-STAT™

Anitmicrobial Hand Soap

Active Ingredient: 0.5% Chloroxylenol

6000033

Net Contents: 540 mL (18 fl oz)

Ecolab · 370 Wabasha Street N ·

St Paul MN 55102-1390 USA

© 2012 Ecolab USA Inc · All rights reserved

Made in United States

www.ecolab.com · 753737/8500/1012

INGREDIENTS AND APPEARANCE

ECOLAB
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5.20 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 CPS AT 1%) (UNII: 7Q6P4JN1QT)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
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:47593-501-31	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2012
2	NDC:47593-501-32	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2012
3	NDC:47593-501-26	1000 mL in 1 POUCH; Type 0: Not a Combination Product	10/25/2012
4	NDC:47593-501-11	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/2012
5	NDC:47593-501-56	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/2012
6	NDC:47593-501-41	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2013
7	NDC:47593-501-59	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/24/2012

Labeler - Ecolab Inc. (006154611)

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Medic

ECOLAB (CHLOROXYLENOL) SOLUTION [ECOLAB INC.]

Do not use

When using this product

Stop use and ask a doctor if

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