ANTIMICROBIAL FOAM HANDWASH- chlorhexidine gluconate 2% solution liquid

Antimicrobial Foam Handwash by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

Antiseptic

Directions:/ Mood de Uso:

Warnings/Precauciones

For external use only

Allergy Alert:

This product may cause a severe allergic reaction. Symptoms may include:

• wheezing/difficulty breathing
• shock
• facial swelling
• hives
• rash

If an allergic reaction occurs, stop use and seek medical help right away

Para Use Externo Únicamente

Alerta De Allergia:

Este producto puede causar un reacción alérgica severa. Los síntomas pueden incluir:

• sibilancias/dificultad para respirar
• shock
• hinchazón facial
• urticaria
• sarpullido

En caso de ocurrir alguna reacción alérgica, detenga el uso y busque ayuda de inmediato

Do not use/No debe usante

If you are allergic to chlorhexidine gluconate or any other ingredients

Si es alérgico al gluconato de chlorhexidina o a cualquier otro ingrediente

When using this product/ Cuando use este producto

Keep out of eyes, ear and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle of the ear through perforated eardrums. If solution should contact these areas, rinse out promptly and thoroughly with water.

Evite el contacto con los ojos, oídos, y boca. Puede causar daño ocular serio y permanente si se coloca o permanece en el ojo durante procedimientos quirúrgicos o puede causar sordera si se instila en el oído medio a través de tímpano perforado. Si la solución llegara a tener contacto con estas àreas, enjuague lo más pronto posible con suficiente agua.

Stop use an ask a doctor if/ Mantengase fuera consulte a su médico si

Irrititation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Reacciones de irritación, sensibilización o reacciones alérgicas aparecen. Estos son signos de una condicíon seria.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

En caso de ingestión, busque ayuda médica o contacte al centro de control de intoxicación de inmediato.

ACTIVE INGREDIENT

Chlorhexidine Gluconate/Gluconato de chlorhexidina 20 MG/G

INACTIVE INGREDIENT

Citric acid, cocamide DEA, hydroxyethlycellulose, isopropyl alcohol, lauramine oxide, aqua

INDICATIONS & USAGE

Antimicrobial Handwash

PRINCIPAL DISPLAY PANEL

Chlorhexidine Gluconate 2% Solution

NDC: 21749-416-89

GOJO Industries, Inc

Akron, OH 44309

+330 255-6000

www.GOJO.com

GOJOLTXINTLLBL

Net Wt 1200 mL

Chlorhexidine Gluconate 2% Solution

NDC: 21749-416-90

GOJO Industries, Inc

Akron, OH 44309

+330 255-6000

www.GOJO.com

GOJOADXINTLLBL

Net Wt 1250 mL

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL FOAM HANDWASH 
chlorhexidine gluconate 2% solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-416
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-416-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2018
2	NDC: 21749-416-90	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	04/01/2018

Labeler - GOJO Industries, Inc. (004162038)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(21749-416)