Xtt Cardinal Health 4%

Xtt Cardinal Health 4%
SPL v10
SPL
SPL Set ID 4a645652-ae2f-3811-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Gluconolactone Peg-75 Lanolin Tridecyl Alcohol Coco Diethanolamide Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Lauramine Oxide Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2015-07-24 Until 2020-03-31

Description

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% Solution

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 cleansing
Section 55106-9

Chlorhexidine gluconate 4% Solution

Section 60561-8

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.

Warnings

For external use only

Allergy alert:

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

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Direction
  • 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 throughly
  • 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 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 procecedure 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
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
Package Label

NDC: 63517-061-04

AS-4CHGL4

Cardinal Health

Chlorhexidine Gluconate 4% Solution

Single-Use Antiseptic

Non Sterile Solution

4 fl oz (118mL)

NDC: 63517-061-08

AS-4CHGL8

Cardinal Health

Chlorhexidine Gluconate 4% Solution

Antiseptic

8 fl oz (237 mL)

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

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.


Structured Label Content

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 cleansing
Section 55106-9 (55106-9)

Chlorhexidine gluconate 4% Solution

Section 60561-8 (60561-8)

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.

Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

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

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Direction
  • 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 throughly
  • 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 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 procecedure 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
Do Not Use (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
Package Label

NDC: 63517-061-04

AS-4CHGL4

Cardinal Health

Chlorhexidine Gluconate 4% Solution

Single-Use Antiseptic

Non Sterile Solution

4 fl oz (118mL)

NDC: 63517-061-08

AS-4CHGL8

Cardinal Health

Chlorhexidine Gluconate 4% Solution

Antiseptic

8 fl oz (237 mL)

Other Information (other information)
  • store at 20-25 C (68-77 F)
  • avoid excessive heat above 40 C (104 F)

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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