ANTISEPTIC FOAM HANDWASH- chlorhexidine gluconate 2% solution liquid

Antiseptic Foam Handwash by

Drug Labeling and Warnings

Antiseptic Foam Handwash by is a Otc medication manufactured, distributed, or labeled by GOJO Industries, Inc., Xttrium Laboratories, Inc., Xttrium Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient/ Ingrédient Actif

Chlorhexidine Gluconate 2% W/W

Gluconate De Chlorhexidine 2% W/W

Purpose

A general purpose antimicrobial handwash, which kills germs that may cause disease.

Un nettoyant pour les mains antimicrobien á large spectre qui élimine les micro-organismes susceptibles de provoquer des maladies.

Indications

Antiseptic cleanser kills harmful bacteria or germs. Dosage: This product should be used daily, as part of the daily cleansing routine

Nettoyant antiseptique tue les bactéries ou les germes nocifs. Posologie: Utiliser par jour, dan le cadre du régime de nettoyage quotidien.

Directions/Mode D'emploi

Wet hands. Apply an adequate amount of soap and work into a rich lather for 15-30 seconds. Rinse thoroughly with water. Dry hands completely.

Se mouiller les maines. Appliquer une quantité adéquate de savon et frotter les mains pendant 15 á 30 secondes jusqu á obtenir une mousse abondante. Rincer abondamment á l'eau. Sécher soigneusement.

Warnings/Mises en Garde

This product is intended for external use only. Contact with the eyes should be avoided and should this occur, the eye should be flushed with water. If irritation develops or increases, use of the product should be disontinued. If irritattion persists for moe than 5 days, consult a physician. Keep out of reach of children.

Pour usage externe seulement, éviter tout contact avec les yeux, le cas échéant, rincer abondamment avec de l'eau, si une irritation apparaít ou s'accentue, cesser l'empoli. Si l'irritation persiste pendant plus de 5 jours, consulter un médcin. Garder hors de portée des enfants.

Keep out of reach of children

Inactive Ingredients

Citric acid, cocamide DEA, Hydroxyethylcellulose, Isopropyl Alcohol, Lauramine Oxide, Water (Aqua)

Acide citrique, diéthanolamide de coprah, hydroxyéthylcellulose, alcool isopropylique, oxyde de la diméthylamine laurique, Eau

PRINCIPAL DISPLAY PANEL

NDC: 21749-461-89

Chlorhexidine Gluconate 2% Solution

Antiseptic Lotion Soap

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

330-255-6000

www.GOJO.com

GOJO Canada, Inc.

1100 Squires Beach Road

Pickering, ON L1W 3N8

FRONTTTFXCANLBLB

NDC: 21749-461-89

Chlorhexidine Gluconate 2% Solution

Antiseptic Lotion Soap

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

330-255-6000

www.GOJO.com

GOJO Canada, Inc.

1100 Squires Beach Road

Pickering, ON L1W 3N8

BACKGOJOCANLBLA

INGREDIENTS AND APPEARANCE

ANTISEPTIC FOAM HANDWASH 
chlorhexidine gluconate 2% solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-461
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-461-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	12/01/2011

Labeler - GOJO Industries, Inc. (004162038)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc		007470579	manufacture(21749-461)