DIGICLEAN - chloroxylenol solution
Ecolab Inc.

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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Active Ingredient

Chloroxylenol, 0.6%

Purpose

Antiseptic handwash

Uses

For use by health care personnel between patient contact to help reduce the incidence of infection

Warnings

For external use only

Do not use

In eyes

When using this product

Discontinue use if irritation and redness develop

Stop use and ask a doctor if

Skin irritation and redness persist 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
Use once or twice daily as part of a daily cleaning routine

Other information

For additional information, see Material Safety Data Sheet (MSDS)
For emergency medical information in USA and Canada call 1-800-328-0026
For emergency medical information worldwide, call 1-651-5352 in the USA)

Inactive ingredients

aloe barbadensis, boric acid, cocamide DEA, cocamine oxide, DC red 33, fragrance, glycol stearate, hydroxyethylcellulose, isopropyl alcohol, methylparaben, PEG-75 lanolin, potassium cocoate, potassium stearate, propylene glycol, propylparaben, tetrasodium EDTA, tetrasodium pyrophosphate, water

Questions?

Call 1-800-35-CLEAN (352-5326)

Principle Display Panel/Representative Label

ECOLAB

NDC 47593-389-29

DIN 02268337

DigiClean

Healthcare

Personnel Handwash

Chloroxylenol, 0.6%

Digits

22639

Net Contents: 950 mL/32 fl oz

Ecolab Inc., Institutional Division

370 Wabasha Street N, St. Paul, MN 55102-1390 USA

Distributed in Canada by Ecolab Co.

5105 Tomken Road, Mississuaga Ont. Canada L4W 2X5

representative label

DIGICLEAN
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-389
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (CHLOROXYLENOL)	CHLOROXYLENOL	0.6 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM PYROPHOSPHATE
EDETATE SODIUM
PROPYLPARABEN
PROPYLENE GLYCOL
POTASSIUM STEARATE
POTASSIUM COCOATE
PEG-75 LANOLIN
METHYLPARABEN
ISOPROPYL ALCOHOL
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
GLYCOL STEARATE
D&C RED NO. 33
COCAMINE OXIDE
COCO DIETHANOLAMIDE
BORIC ACID
ALOE VERA LEAF

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:47593-389-24	950 mL in 1 BAG	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/17/2004	05/21/2012

Labeler - Ecolab Inc. (006154611)

Revised: 05/2012 Ecolab Inc.