CARDINAL HEALTH- chlorhexidine gluconate 4% liquid 
Xttrium Laboratories, Inc.

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Drug Facts Cardinal Health 4%

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic

Uses

Warnings

For external use only

Allergy alert:

​This product may cause a severe allergic reation. Symptoms may include:

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
  • as a preoperative skin preparation of the head or face

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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.

Direction

Surgical hand scrub:

Healthcare personnel handwash:

Patient preoperative skin preparation:

Skin wound and general skin cleansing:

other information

Inactive ingredients

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

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 informationm, go to P65Warnings.ca.gov

For Professional and Hospital Use Only

You may report serious side effects to 1-877-227-3642

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

4 fl oz (118mL)

4CHA04 PDP

4CHA04 DF1

4CHA04 DF2

4CHA04 DF3

NDC: 63517-061-08

AS-4CHGL8

Cardinal Health

Chlorhexidine Gluconate 4% Solution

Antiseptic

8 fl oz (237 mL)

4CHA08 PDP

4CHA08 DF1

4CHA08 DF2

4CHA08 DF3

CARDINAL HEALTH 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0061-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2015
2NDC:0116-0061-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2015
3NDC:0116-0061-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/201511/30/2019
4NDC:0116-0061-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/201503/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912507/24/2015
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-0061)

Revised: 2/2021
Document Id: bb2b6cd5-ec59-4142-e053-2a95a90a74df
Set id: 4a645652-ae2f-3811-e054-00144ff8d46c
Version: 8
Effective Time: 20210212
 
Xttrium Laboratories, Inc.