Drug Facts

Active ingredient

chlorhexidine gluconate 4% 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

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.

Surgical hand scrub:

wet hands and forearms with water
scrub for 3 minutes with about 2.0 cubic inches of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
a separate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 2.0 cubic inches of product and rinse under running water
dry thoroughly

Healthcare personnel handwash:

wet hands with water
dispense 1.5 cubic inches of product 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

cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions or comments?

call 1-800-453-4538 Monday through Friday 8 AM to 5 PM EST

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine) which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

NDC 17271-505-02

BD E-Z Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

REF 372412

Foreign Patents and Patents Pending

U.S. Patent 6,427,875

CHLORHEXIDINE GLUCONATE

32 fl oz (946 mL)

4BD32SQ

NDC 17271-505-01

BD E-Z Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

REF 372402

Foreign Patents and Patents Pending

U.S. Patents 6,053,369 6,308,866

Chlorhexidine Gluconate

32 fl oz (946 ml)

4BD32RND

BD E-Z SCRUB
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0116-0505
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-75 LANOLIN (UNII: 09179OX7TB)
WATER (UNII: 059QF0KO0R)
TRIDECYL ALCOHOL (UNII: 8I9428H868)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0116-0505-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2006
2	NDC:0116-0505-02	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019127	01/01/2006

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0505)

BD EZ Scrub 4%CHG 1060 Solution