Chlorhexidine Gluconate

Chlorhexidine Gluconate
SPL v1
SPL
SPL Set ID 1f1eebef-9aac-b847-e063-6394a90a26cc
Route
TOPICAL
Published
Effective Date 2024-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (40 mg)
Inactive Ingredients
Coco Diethanolamide Cocamine Oxide Gluconic Acid Gluconolactone Isopropyl Alcohol Peg-75 Lanolin Peg-150 Distearate Propylene Glycol Quaternium-33 Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1986-07-22

Description

Chlorhexidine gluconate solution, 4%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate solution, 4%

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

If an allergic reaction occurs, stop use and seek medical help 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 4 full pumps (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 with water
  • wash for an additional 3 minutes with 5 mL of the product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash:

  • wet hands with water
  • dispense 4 full pumps (about 5 mL) of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleanser:

  • thoroughly rinse the area to be cleansed 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 are allergic to chlorhexidine gluconate or any other ingredient in this preparation
  • as a patient preoperative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
Active Ingredient

Chlorhexidine gluconate solution, 4%

Other Information
  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
Questions Or Comments?

Call 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM CT.

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 the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a healthcare provider
inactive Ingredients

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water *contains one or more of these ingredients

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.

Representative Label and Principal Display Panel

Chlorhexidine Gluconate Liquid Foaming Solution

4%

Antiseptic Skin Cleanser

NDC 42939-125-26

4 fl oz (118 mL)

Non-Sterile.

For External Use only.

Manufactured by:

AVA Inc., Willowbrook IL 60527

Made in USA

Issued: 07/2024.

Keep from freezing.

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 amides, coco, n,n-bis(hydroxyethyl) and 2,2’-iminodiethanol which are known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.


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
  • skin wound and general skin cleansing
Purpose

Antiseptic

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.

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 4 full pumps (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 with water
  • wash for an additional 3 minutes with 5 mL of the product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash:

  • wet hands with water
  • dispense 4 full pumps (about 5 mL) of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleanser:

  • thoroughly rinse the area to be cleansed 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 are allergic to chlorhexidine gluconate or any other ingredient in this preparation
  • as a patient preoperative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
Active Ingredient (Active ingredient)

Chlorhexidine gluconate solution, 4%

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
Questions Or Comments? (Questions or comments?)

Call 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM CT.

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
  • 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 healthcare provider
inactive Ingredients (Inactive ingredients)

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water *contains one or more of these ingredients

Stop Use and Ask A Doctor If (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.

Representative Label and Principal Display Panel (Representative label and principal display panel)

Chlorhexidine Gluconate Liquid Foaming Solution

4%

Antiseptic Skin Cleanser

NDC 42939-125-26

4 fl oz (118 mL)

Non-Sterile.

For External Use only.

Manufactured by:

AVA Inc., Willowbrook IL 60527

Made in USA

Issued: 07/2024.

Keep from freezing.

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 amides, coco, n,n-bis(hydroxyethyl) and 2,2’-iminodiethanol which are known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.


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