SCRUB CARE EXIDINE-2 CHG- chlorhexidine gluconate solution

Scrub Care by

Drug Labeling and Warnings

Scrub Care by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc., Xttirum Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chlorhexidine gluconate 2% Solution

Purpose

Antiseptic

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
• skin wound and general cleansing

Warnings

For external use only

Alergy 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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
• in contact with meninges
• in the genital area

When using this product

• keep out of eyes, ears, and mouth. May cause serious and permanent eye if permitted to enter and remain in the eye of 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 which involve more than the superficial layers of skin should not be routinely treated
• repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Stop use and ask a doctor if

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

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 under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
• scrub for 1.5 minutes with about 8 ml of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers

Healthcare personnel handwash:

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

Skin wound and general skin cleansing:

• thoroughly rinse the area to be cleaned with water
• apply the minimum amount of product necessary to cover the skin or wound area and wash gently
• rinse again thoroughly

Other information

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

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

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

Package Label

Cat. 29900-232 NDC: 0116-2992-32

Scrub Care
Exidine -2 CHG 2%

Chlorhexidine Gluconate 2% Solution
Antiseptic

Contains: 2% Chlorhexidine Gluconate
For External Use Only

Distributed By:

CareFusion, Inc.
Vernon Hills, IL 60061 USA

51-10093

2CFB32BTLLBLB

Net Contents: 32 fl oz (1 qt) (946 ml)

CareFusion

INGREDIENTS AND APPEARANCE

SCRUB CARE  EXIDINE-2 CHG
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-2992
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-2992-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2010
2	NDC: 0116-2992-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2010
3	NDC: 0116-2992-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2010
4	NDC: 0116-2992-17	473 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/01/2010
5	NDC: 0116-2992-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2010
6	NDC: 0116-2992-33	946 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/01/2010
7	NDC: 0116-2992-01	3786 mL in 1 JUG; Type 0: Not a Combination Product	05/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	05/01/2010

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttirum Laboratories, Inc.		007470579	manufacture(0116-2992)