SCRUB CARE EXIDINE -4 CHG- chlorhexidine gluconate liquid

Scrub Care by

Drug Labeling and Warnings

Scrub Care 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 4% Solution

Purposes

Antiseptic

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hand and forearms prior to surgery or patient care
• healthcare personnel hand wash: 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 doctor

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

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

Direction

• 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 arms and forearms with water
• scrub for 3 minutes with about 5 ml 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 5 ml of product and rinse under running water
• dry thoroughly

Healthcare personnel handwash:

• wet hands water
• dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
• rinse and dry thoroughly.

Other Information

• Store at 20-25º C (68-77ºF)
• Avoid excessive heat above 40ºC (104ºF)

Inactive Ingredients

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

Questions or comments?

1-800-587-3721 (Mon. - Fri. 8:00 AM - 4:30 PM CST)

Principal Display Panel

Cat. 4CHG4

NDC: 0116-4444-30

Scrub Care
Exidine -4 CHG 4%

Chlorhexidine Gluconate 4% Solution
Antiseptic

Contains: 4% Chlorhexidine Gluconate
For External Use Only

Distributed by:
CareFusion, Inc.
Vernon Hills, IL 60061 USA

51-10104 4CF30BTLLBLA

Net Contents: 30 fl oz (887 mL)

To Install

1. Twist to remove plug from back of dispenser spout.

2. Seat dispenser into bracket, taking care to insert the open air inlet into proper receptacle.

3. Twist to remove plug from end of spout.

To Remove

1. Hold bracket against the wall and pull the empty dispenser straight forward.

2. Discard entire bottle and spout.

principal display panel media

Cat. 4CHG4

NDC: 0116-4444-30

Scrub Care®

Exidine® -4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed By

CareFusion, Inc.

Vernon Hills, IL 60061 USA

4CF30BTLBLB

Cat. 4CHG4-FM

NDC: 0116-4444-31

Scrub Care®

Exidine® -4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed By

CareFusion, Inc.

Vernon Hills, IL 60061 USA

4CHG30BTLFMLBLB

INGREDIENTS AND APPEARANCE

SCRUB CARE  EXIDINE -4 CHG
chlorhexidine gluconate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-4444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
PEG-75 LANOLIN (UNII: 09179OX7TB)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-4444-30	887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
2	NDC: 0116-4444-31	887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	11/01/2012

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-4444)