CARDINAL HEALTH- chlorhexidine gluconate 4% liquid

Cardinal Health by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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
• patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
• 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/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 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
• wound 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 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 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 productand inse under running water
• dry thoroughly

Healthcare personnel handwash:

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

Patient preoperative skin preparation:

• apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
• repeat procedure for an additional 2 minutes and dry with a sterile towel

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

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

OTHER SAFETY INFORMATION

Laundering/Cleaning Instructions:

Chlorhexidine Gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

Warning: This product can expose you to chemicals including cocamide DEA, which is known to the State of California to cause cancer. For more information, go to P65Warnings.ca.gov

For Professional and Hospital Use Only

You may report serious side effects to 1-877-227-3462

Not Made with Natural Rubber Latex

Distributed by

Cardinal Health

Waukegan, IL 60085 USA

Rev. D 2019-07 cardinalhealth.com

© 2019 Cardinal Health. All Rights Reserved.

CARDINAL HEALTH and the Cardinal Health LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries.

Package Label

NDC: 63517-061-04

AS-4CHGL4

Cardinal Health

Chlorhexidine Gluconate

4% Solution

Single Use Antiseptic

Non Sterile Solution

Distributed by: Cardinal Health

Waukegan, IL 60085 USA

Rev. D 2019-07 cardinalhealth.com

© 2019 Cardinal Health. All Rights Reserved.

CARDINAL HEALTH and the Cardinal Health LOGO

are trademarks of Cardinal Health and may be

registered in the US and/or in other countries.

4 fl oz (118 mL)

NDC: 63517-061-08

AS-4CHGL8

Cardinal Health

Chlorhexidine Gluconate

4% Solution

Antiseptic

8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH 
chlorhexidine gluconate 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-061
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
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-061-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2015
2	NDC: 63517-061-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2015
3	NDC: 63517-061-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2015	11/30/2019
4	NDC: 63517-061-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2015	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	07/24/2015

Labeler - Cardinal Health (097537435)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(63517-061)