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Cardinal Health Antiseptic Skin Cleanser

Medically reviewed on January 24, 2017

Dosage form: solution
Ingredients: CHLORHEXIDINE GLUCONATE 2g in 100mL
Labeler: Xttrium Laboratories, Inc.
NDC Code: 0116-1130

Drug Facts

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
  • 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

Do not use
  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • 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
  • 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 the underlying condition makes it necessary to reduce the bacterial population of the skin

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 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 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

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

WARNING: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

For Professional and Hospital Use

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

Package Label

NDC: 63517-113-04

Chlorhexidine Gluconate 2% Solution

antiseptic

Cat. AS 2CHGL4

Distributed by:

Cardinal Health™

Waukegan, IL 60085 USA

cardinalhealth.com

Rev. A 02\16

2CHA04BTLLBLA

Net Wt 4 fl oz (118 mL)

NDC: 63517-113-08

Chlorhexidine Gluconate 2% Solution

antiseptic

Cat. AS 2CHGL8

Distributed by:

Cardinal Health™

Waukegan, IL 60085 USA

cardinalhealth.com

Rev. A 02\16

2CHA08BTLLBLA

Net Wt 8 fl oz (237 mL)

NDC: 63517-113-16

Chlorhexidine Gluconate 2% Solution

antiseptic

Cat. AS 2CHGL16

Distributed by:

Cardinal Health™

Waukegan, IL 60085 USA

cardinalhealth.com

Rev. A 02\16

2CHA16BTLLBLA

Net Wt 16 fl oz (473 mL)

NDC: 63517-113-32

Chlorhexidine Gluconate 2% Solution

antiseptic

Cat. AS 2CHGL32

Distributed by:

Cardinal Health™

Waukegan, IL 60085 USA

cardinalhealth.com

Rev. A 02\16

2CHA32BTLLBLA

Net Wt 32 fl oz (946mL)

CARDINAL HEALTH ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 2% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LAURAMINE OXIDE 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
COCO DIETHANOLAMIDE 
WATER 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:0116-1130-04118 mL in 1 BOTTLE, PLASTIC
2NDC:0116-1130-08237 mL in 1 BOTTLE, PLASTIC
3NDC:0116-1130-16473 mL in 1 BOTTLE, PLASTIC
4NDC:0116-1130-32946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01942205/01/2015
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIOperations
Xttirum Laboratories, Inc.007470579manufacture(0116-1130)

 
Xttrium Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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