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 Ingredients

Chlorhexidine Gluconate 4% 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 skin cleansing

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

• wheezing/diccidulty breathing
• 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 genital area

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 eardrugs..
• if solution should contact these areas, rinse out promptly and thoroughly with water
• wounds which involve more than the superficial layers of the 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 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

Warning

This product contains a chemical known to the State of California to cause cancer.

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

Skin wound and normal 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

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

Questions or comments?

Call 1-800-587-3721

Monday through Friday 8:00 AM to 4:30 PM CST

Package label and principal display panel

Cat. 29900-404

NDC: 0116-2994-04

Scrub Care®

Exidine® -4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

For Single Use Only

Distributed By

CareFusion, Inc.

Vernon Hills, IL 60061 USA

51-10096

4CF04BTLLBLD

Net Contents: 4 fl oz (118 mL)

Cat. 29900-408

NDC: 0116-2994-08

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

51-10096

4CF08BTLLBLD

Net Contents: 8 fl oz (237 mL)

Cat. 29900-416

NDC: 0116-2994-16

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

51-10096

4CF16BTLLBLB

Net Contents: 16 fl oz (473 mL)

Cat. 29900-416P

NDC: 0116-2994-17

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

51-10096

4CF16BTLPLBLB

Net Contents: 16 fl oz (473 mL)

Cat. 29900-432

NDC: 0116-2994-32

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

51-10096

4CF32BTLLBLB

Net Contents: 32 fl oz (1 qt)

Cat. 29900-432P

NDC: 0116-2994-33

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

51-10096

4CF32BTLPLBLB

Net Contents: 32 fl oz (1 qt)

Cat. 29900-401

NDC: 0116-2994-01

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

51-10096

4CF01GBTLLBLC

Net Contents: 128 fl oz (1 gal) (3.8 L)

INGREDIENTS AND APPEARANCE

SCRUB CARE  EXIDINE -4 CHG
chlorhexidine gluconate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-2994
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)
PEG-75 LANOLIN (UNII: 09179OX7TB)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-2994-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
2	NDC: 0116-2994-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
3	NDC: 0116-2994-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
4	NDC: 0116-2994-17	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
5	NDC: 0116-2994-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
6	NDC: 0116-2994-33	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2012
7	NDC: 0116-2994-01	15142 mL in 1 JUG; 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(0116-2994)