ZALIEX ALCOHOL-FREE ANTISEPTIC HAND SANITIZER - benzalkonium chloride liquid
SAS Healthcare 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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Zaliex Alcohol-Free Antiseptic Foam Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses:

For hand cleansing to decrease bacteria on the skin
Recommended for repeated use

Warnings:

For external use only.

Do not use in eyes. If contact occurs, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops.

If condition persists for more than 72 hours, consult a doctor.

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

Directions:

Pump a small amount of foam into palm of hand
Wet hands thoroughly with product and allow to dry without wiping.
Rub hands together briskly until dry

Inactive Ingredients:

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

Manufactured for:

Zaliex

Suite 210, 4 Robert Speck Parkway,

Mississauga, Ontario, L4Z1S1, Canada

Zaliex Alcohol-Free Antiseptic Foam Hand Sanitizer 250ml (76452-003-00) | Zaliex Alcohol-Free Antiseptic Foam Hand Sanitizer 550ml (76452-003-01)

ZALIEX ALCOHOL-FREE ANTISEPTIC HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76452-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

#	Item Code	Package Description
Packaging
1	NDC:76452-003-00	250 mL in 1 BOTTLE
2	NDC:76452-003-01	550 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/13/2012

Labeler - SAS Healthcare Inc (248055696)

Name	Address	ID/FEI	Business Operations
Establishment
Artemis Bio-Solutions Inc.		963442541	manufacture(76452-003)