Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d53a01eb-7213-4f19-b74f-acbf0fd54418
Route
TOPICAL
Published
Effective Date 2026-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (40 mg)
Inactive Ingredients
Cocamine Oxide Gluconolactone Peg-75 Lanolin Propylene Glycol Coco Diethanolamide Gluconic Acid Hydroxyethyl Cellulose (3000 Cps At 1%) Peg-150 Distearate Quaternium-33 Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2023-07-26

Description

Chlorhexidine gluconate solution, 4%

Purpose

Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser


Medication Information

Purpose

Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

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: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general skin cleanser: helps reduce bacteria on the skin
Section 50569-3

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Section 51945-4

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-12; 118 mL in 1 BOTTLE

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-24; 236 mL in 1 BOTTLE

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-48; 473 mL in 1 BOTTLE

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-95; 946 mL in 1 BOTTLE

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

Warnings

For external use only

Directions
  • use with care in premature infants or infants under 2 months of age. These product may cause irritation or chemical burns.
  • use full strength
  • do not dilute

Surgical hand scrub:

  • remove jewelry
  • wet hands and forearms with water and apply 5 mL of the product
  • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • 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 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 thoroughly with water.
  • rinse again thoroughly
Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
  • as a patient properative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
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.

Other Information
  • store between 20-25 °C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately
Active Ingredients

Chlorhexidine gluconate solution, 4%

Inactive Ingredients

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

Questions Or Comments?

Call 1-884-874-7464 Monday through Friday 8:00 AM to 5:00 PM EST

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

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.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Keep from freezing.

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 ear drums
  • if contact occurs, rinse with cold water right away
  • 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 underlying condition makes it necessary to reduce the bacterial population of the skin
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: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general skin cleanser: helps reduce bacteria on the skin
Section 50569-3 (50569-3)

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Section 51945-4 (51945-4)

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-12; 118 mL in 1 BOTTLE

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-24; 236 mL in 1 BOTTLE

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-48; 473 mL in 1 BOTTLE

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-95; 946 mL in 1 BOTTLE

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

Warnings

For external use only

Directions
  • use with care in premature infants or infants under 2 months of age. These product may cause irritation or chemical burns.
  • use full strength
  • do not dilute

Surgical hand scrub:

  • remove jewelry
  • wet hands and forearms with water and apply 5 mL of the product
  • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • 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 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 thoroughly with water.
  • rinse again thoroughly
Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
  • as a patient properative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
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.

Other Information (Other information)
  • store between 20-25 °C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately
Active Ingredients (Active ingredients)

Chlorhexidine gluconate solution, 4%

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-884-874-7464 Monday through Friday 8:00 AM to 5:00 PM EST

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

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.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Keep from freezing.

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 ear drums
  • if contact occurs, rinse with cold water right away
  • 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 underlying condition makes it necessary to reduce the bacterial population of the skin
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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