BD E-Z SCRUB- chlorhexidine gluconate solution

BD E-Z Scrub by

Drug Labeling and Warnings

BD E-Z Scrub by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

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)

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)

INGREDIENTS AND APPEARANCE

BD E-Z SCRUB 
chlorhexidine gluconate solution

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019127	01/01/2006

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

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