PROVON ANTIMICROBIAL FOAM HANDWASH- chlorhexidine gluconate 2% solution

Provon Antimicrobial Foam Handwash by

Drug Labeling and Warnings

Provon 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

chlorhexidine gluconate 2% solution

Purpose

surgical hand scrub

healthcare personnel handwash

Uses

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

Warnings

For external use only

Do not use

• if you are allergic to chlorhexidine gluconate or any other ingredients
• in contact with meninges
• in the genital area
• as a preoperative skin preparation of the head or face

When using this product

• keep out of eyes, ears, and mouth
• may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums
• if solution should contact these areas, rinse out promptly and thoroughly with water
• wounds that involve more than the superficial layers of the skin should not be routinely treated
• repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population 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 or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

• wet hands and forearms with water
• scrub for 3 minutes with 5 ml of solution and a wet brush paying close attention to the nails, cuticles, and interdigital space
• a separate nail cleaner may be used
• rinse thoroughly
• wash for an additional 3 minutes with 5 ml of solution and rinse under running water
• dry thoroughly

Healthcare personnel handwash:

• wet hands with water
• dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
• dry thoroughly

Other information

• store at 20-25° C (68-77° F)
• avoid excessive heat above 40° C (104° F)

Inactive ingredients

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

call 1-800-321-9647 Monday through Friday 8 AM to 5 PM MST

PRINCIPAL DISPLAY PANEL

NDC: 21749-850-53

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Gojo Industries, Inc.

Akron, OH 60085 USA

330-255-6000

www.gojo.com

GOJO18BTLLBL

Gojo ® 2015

Net Wt 18 fl oz (535 mL)

INGREDIENTS AND APPEARANCE

PROVON ANTIMICROBIAL FOAM HANDWASH 
chlorhexidine gluconate 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-850
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
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-850-53	535 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	05/01/2016

Labeler - Gojo Industries, Inc. (004162038)

Registrant - Xttrium Laboratories, Inc. (007470579)