Halyard Chlorhexidine Gluconate Solution
FDA Label NDC 39892-0960

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Owens & Minor, Inc. for the product Halyard Chlorhexidine Gluconate (NDC 39892-0960). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ inactive Ingredients

→ Questions Or Comments?

→ Representative Label And Principal Display Panel 4 Fl Oz (118 Ml) Chlorhexidine Gluconate 4% Solution Liquid | Flip Top

Active Ingredient

Chlorhexidine gluconate solution, 4%

Purpose

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 ingredient in this preparation
as a patient preoperative 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 eardrums.
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

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.

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.
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*, hydroxyethyl cellulose, 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 1-844-425-9273 Monday through Friday 8:00 AM to 5:00 PM CT.

Representative Label And Principal Display Panel 4 Fl Oz (118 Ml) Chlorhexidine Gluconate 4% Solution Liquid | Flip Top

NDC 39892-0960-1

HALYARD*

Chlorhexidine Gluconate 4% Solution

Antiseptic

Liquid

Flip Top

REF 56176

4 fl oz (118 mL)

Non-Sterile.

For External Use only.

Manufactured for O&M Halyard, Inc.,
9120 Lockwood Blvd.,VA 23116, USA
In USA, please call 1-844-425-9273 • halyardhealth.com
*Registered Trademark or Trademark of O&M Halyard, Inc., or its affliates.

Made in USA

Rev. A

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.