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 Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

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 permanent eye injury if permitted to enter and remain in the eye 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
• 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 or 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 (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly

Surgical hand scrub:

• wet hands and forearms with water
• scrub for 3 minutes with 5 mL of product (6 full stokes), 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 (6 full strokes) and rinse under running water and 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 8:00 AM to 5:00 PM EST

PRINCIPAL DISPLAY PANEL

PROVON® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOADXFLBLC

8842-643-F

8842

NDC: 21749-850-90

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

42 fl oz (1250 mL)

GOJOADXBLBLB

8842-642-B

PROVON ® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOLTXFLBLC

1922-643-F

.

1922

NDC: 21749-850-89

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

40.5 fl oz (1200 mL)

GOJOLTXBLBLB

1922-642-B

INGREDIENTS AND APPEARANCE

PROVON ANTIMICROBIAL FOAM HANDWASH 
chlorhexidine gluconate 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-8500
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: 0116-8500-89	1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/01/2016
2	NDC: 0116-8500-90	1250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	07/01/2016

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-8500)