DEPHYZE ANTISEPTIC FOAM HAND SANITIZER - benzalkonium chloride spray
MicroPure Solutions, LLC dba Tionicon

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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DepHyze Alcohol Free Antiseptic Foam Hand Sanitizer

Drug Facts

Active Ingredient Purpose

Benzalkonium Chloride 0.13 percent Antiseptic

Uses:

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings:

For external use only. Do not use in the eyes.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed , get medical help or contact a Poison Control Center right away.

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Behentrimonium Chloride, Citric Acid, Dihydroxyethyl Cocamide Oxide, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Fragrance, Glycereth-2 Cocoate, Glycerin, Potassium Carbonate, Water.

No Rinse - Leaves Skin Soft

Exp. Date 3 2001

DepHyze
Alcohol Free
Antiseptic Foam
Hand Sanitizer

Effective to 99.999 percent on germs that cause illnesses

Net Weight 1.7 fl oz (50 mL)

Tionicon
www.tionicon.com
Aurora, CO
Made in U.S.A.

DepHyzeHandSanitizer

DEPHYZE ANTISEPTIC FOAM HAND SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49765-100
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	0.13 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE
GLYCERIN
POTASH
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49765-100-10	50 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	11/01/2009

Labeler - MicroPure Solutions, LLC dba Tionicon (805764508)

Registrant - MicroPure Solutions, LLC dba Tionicon (805764508)

Name	Address	ID/FEI	Business Operations
Establishment
MicroPure Solutions, LLC dba Tionicon		805764508	manufacture

Revised: 12/2009

Document Id: 0a08ebb5-a4ac-43a8-a134-6c7147e23228

Set id: 63e11e47-1acf-4dd8-9558-fec74855ff0e

Version: 3

Effective Time: 20091207

MicroPure Solutions, LLC dba Tionicon