FDA Label for Chlorhexidine Gluconate

Active Ingredients

Chlorhexidine gluconate solution, 4%

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

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

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.

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

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.

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

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

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.

Issued: 07/2023