Halyard Chlorhexidine Gluconate — Solution

Overview

Brand name

Halyard Chlorhexidine Gluconate

Generic name

Chlorhexidine Gluconate

Dosage form

Solution

Route

Topical

Marketing category

NDA · NDA

Labeler

Owens & Minor, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Chlorhexidine Gluconate	40 mg/mL	1667684	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Topical

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Decreased Cell Wall Integrity [PE]	PE	All 26 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

019258

Application type

NDA · New Drug Application

Approval date

July 22, 1986

Sponsor

ECOLAB

Products on application

2

Submissions recorded

18

Products approved under application 019258.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
019258-001	CIDA-STAT	SOLUTION		CHLORHEXIDINE GLUCONATE	Over-the-counter	—
019258-002	CHG SCRUB	SOLUTION		CHLORHEXIDINE GLUCONATE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 019258.
Type	No.	Action	Status	Date	Review
Supplement	26	Labeling	Approved	January 10, 2018	Standard
Supplement	23	Manufacturing (CMC)	Approved	January 14, 2016	Standard
Supplement	22	Manufacturing (CMC)	Approved	December 28, 2015	Standard
Supplement	21	Manufacturing (CMC)	Approved	August 5, 2015	Standard
Supplement	20	Manufacturing (CMC)	Approved	December 16, 2014	Standard
Supplement	19	Labeling	Approved	May 17, 2012	Standard
Supplement	16	Labeling	Approved	April 23, 2010	Standard
Supplement	14	Manufacturing (CMC)	Approved	April 3, 2006	Standard
Supplement	11	Manufacturing (CMC)	Approved	February 15, 2005	Standard
Supplement	13	Manufacturing (CMC)	Approved	December 20, 2002	Standard
Supplement	12	Manufacturing (CMC)	Approved	July 25, 2002	Standard
Supplement	10	Manufacturing (CMC)	Approved	April 17, 2001	Standard
Supplement	8	Labeling	Approved	December 8, 1995	Standard
Supplement	9	Manufacturing (CMC)	Approved	August 16, 1995	Standard
Supplement	6	Manufacturing (CMC)	Approved	May 10, 1993	Standard
Supplement	7	Manufacturing (CMC)	Approved	May 6, 1993	Standard
Supplement	2	Manufacturing (CMC)	Approved	June 2, 1987	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	July 22, 1986	Standard

Review documents

0 · Supplement · January 17, 2018
0 · Supplement · January 11, 2018
0 · Supplement · January 15, 2016
0 · Supplement · January 15, 2016
0 · Supplement · August 10, 2015
0 · Supplement · May 21, 2012
0 · Supplement · April 28, 2010
0 · Supplement · April 7, 2006
0 · Supplement · February 17, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240904). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240904

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

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

Dosage and Administration

openFDA Drug Labeling

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 (4 pumps) 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 (4 pumps) of the product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL (4 pumps) 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

Warnings

openFDA Drug Labeling

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.

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active ingredient Chlorhexidine gluconate solution, 4%

Adverse event reports

Source: openFDA FAERS

9,457

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CHLORHEXIDINE GLUCONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
39892-0960-1	39892-0960	Owens & Minor, Inc.	118 mL in 1 BOTTLE, PLASTIC (39892-0960-1)	July 31, 2024
39892-0960-2	39892-0960	Owens & Minor, Inc.	118 mL in 1 CASE (39892-0960-2)	July 31, 2024
39892-0961-1	39892-0961	Owens & Minor, Inc.	118 mL in 1 BOTTLE, PLASTIC (39892-0961-1)	July 31, 2024
39892-0961-2	39892-0961	Owens & Minor, Inc.	118 mL in 1 CASE (39892-0961-2)	July 31, 2024
39892-0960	39892-0960	Owens & Minor, Inc.	—	July 31, 2024
39892-0961	39892-0961	Owens & Minor, Inc.	—	July 31, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.