ANTIMICROBIAL SKIN CLEANSER- chlorhexidine gluconate 2% solution liquid

Antimicrobial Skin Cleanser by

Drug Labeling and Warnings

Antimicrobial Skin Cleanser 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]

Drug Facts

Active ingredient

Chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Uses

• healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Allergy alert:

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

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

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

Do not use

if you are allergic to chlorhexidine gluconate or any other ingredient in this product

When using this product

• keep out of eyes, ears and mouth. May cause serious and permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled through the middle ear through perforated eardrums.
• if solution should contact these areas, rinse out promptly and thoroughly with water
• do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

• wet hands with water
• dispense 5 mL of product (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
• dry thoroughly

Surgical hand scrub:

• wet hands and forearms with water
• scrub for 3 minutes with 5 mL of product (4 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
• a seperate nail cleaner may be used
• rinse thoroughly
• wash for an additional 3 minutes with 5 mL of product (4 full strokes) and rinse under running water and dry thoroughly

OTHER SAFETY INFORMATION

• store at 20-25ºC (68-77ºF)
• avoid excessive heat about 40ºC (104ºF)

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM

PRINCIPAL DISPLAY PANEL

NDC: 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

NDC: 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

NDC: 21749-106-32

PROVON BRAND

Antimicrobial Skin Cleanser

Chlorhexidine Gluconate

2% Solution

Antiseptic

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

Questions?

Tel. 800-321-9647

*330-255-6000

www.GOJO.com

©2018. All rights reserved.

2PROV32BTLLBL

4104-12

Net Contents: 32 fl oz (1qt) (946 mL)

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL SKIN CLEANSER 
chlorhexidine gluconate 2% solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-106
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-106-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2008
2	NDC: 21749-106-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	03/01/2008

Labeler - Gojo Industries, Inc. (004162038)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(21749-106)