Antiseptic Skin Cleanser

Manufacturer: McKesson Medical-Surgical | XTTRIUM LABORATORIES, INC.
Effective date: 2025-01-16
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 00:53:04

Label at a glance#

ProductAntiseptic Skin Cleanser

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure13 sections

Indications and 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 patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dr...

Contacts and useful links#

PhoneLabel contact1-800-777-4908

PhoneLabel contact1-800-587-3721

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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
patient preoperative skin preparation:for the preparation of the patient's skin prior to surgery
skin wound and general skin cleansing

Warnings

WARNINGS SECTION

For external use only

Allergy Alert

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

if you are allergic to chlorhexidine gluconate or any other ingredients in this product
in contact with meninges
in the genital area
as a preoperative skin preparation of the head or face

When using this product

OTC - WHEN USING SECTION

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 the underlying condition makes it necessary to reduce the bacterial population of the skin

OTC - STOP USE SECTION

Stop use and ask doctor ifirritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

SPL UNCLASSIFIED SECTION

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry thoroughly

Patient preoperative skin preparation:

SPL UNCLASSIFIED SECTION

apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleaning:

SPL UNCLASSIFIED SECTION

thoroughly rinse the area to be cleaned with water
apply the minimum amount of product necessary to cover the skin or wound area and wash gently
rinse again thoroughly

Other information

OTHER SAFETY INFORMATION

store at 68-77ºF (20-25°C)
avoid excessive heat above 104°F (40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions?

OTC - QUESTIONS SECTION

General Questions? Call 1-800-777-4908

Technical Support? Call 1-800-587-3721

Principal Display Panel - McKesson Antiseptic Skin Cleanser 4 fl oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5401-2

McKESSON

AntisepticSkin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

4 fl oz
(118 mL)

DO NOT REUSE

MFR # 16-CHG4 CHG4

Principal Display Panel - McKesson Antiseptic Skin Cleanser 8 fl oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5401-3

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

8 fl oz
(237 mL)

MFR # 16-CHG8

CHG8

Principal Display Panel - McKesson Antiseptic Skin Cleanser 16 fl oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5401-4

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

16 fl oz

(473 mL)

MFR # 16-CHG16

CHG16

Principal Display Panel - McKesson Antiseptic Skin Cleanser 32 fl oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5401-5

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

32 fl oz
(946 mL)

MFR # 16-CHG32 16-CHG32

Principal Display Panel - McKesson Antiseptic Skin Cleanser 1 gal Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5401-6

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

1 gal
(3.8 L)

MFR # 16-CHGGL

CHGGL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	10
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	10
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	10
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORHEXIDINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68599-5401-0	Antiseptic Skin Cleanser	4 in 1 CASE	SOLUTION	4	10
68599-5401-1	Antiseptic Skin Cleanser	48 in 1 CASE	SOLUTION	48	10
68599-5401-2	Antiseptic Skin Cleanser	118 mL in 1 BOTTLE	SOLUTION	118	10
68599-5401-3	Antiseptic Skin Cleanser	237 mL in 1 BOTTLE	SOLUTION	237	10
68599-5401-4	Antiseptic Skin Cleanser	473 mL in 1 BOTTLE	SOLUTION	473	10
68599-5401-5	Antiseptic Skin Cleanser	946 mL in 1 BOTTLE	SOLUTION	946	10
68599-5401-6	Antiseptic Skin Cleanser	3800 mL in 1 BOTTLE	SOLUTION	3800	10
68599-5401-7	Antiseptic Skin Cleanser	24 in 1 CASE	SOLUTION	24	10
68599-5401-8	Antiseptic Skin Cleanser	12 in 1 CASE	SOLUTION	12	10
68599-5401-9	Antiseptic Skin Cleanser	12 in 1 CASE	SOLUTION	12	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-5401	ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE) SOLUTION [MCKESSON MEDICAL-SURGICAL]	10	Current NDC, Legacy NDC, 10 package rows	20250119_626d7aa9-b8da-4254-9c57-9007ed4290d4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Antiseptic Skin Cleanser
CHLORHEXIDINE GLUCONATE
COCO DIETHANOLAMIDE
GLUCONOLACTONE
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
PEG-75 LANOLIN
WATER
TRIDECYL ALCOHOL
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68599-5401	68599-5401-2, 68599-5401-1, 68599-5401-3, 68599-5401-7, 68599-5401-4, 68599-5401-8, 68599-5401-5, 68599-5401-9, 68599-5401-6, 68599-5401-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCO DIETHANOLAMIDE	92005F972D	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
PEG-75 LANOLIN	09179OX7TB	IACT
WATER	059QF0KO0R	IACT
TRIDECYL ALCOHOL	8I9428H868	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019125-001	DYNA-HEX 4	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL			1984-12-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	McKesson Medical-Surgical	626d7aa9-b8da-4254-9c57-9007ed4290d4	2025-01-16	Warnings	Exact identifier ndc (package): 68599-5401-0 ndc (package): 68599-5401-8 ndc (package): 68599-5401-2 ndc (package): 68599-5401-7 ndc (package): 68599-5401-5 ndc (package): 68599-5401-1 ndc (package): 68599-5401-3 ndc (package): 68599-5401-6 ndc (package): 68599-5401-4 ndc (package): 68599-5401-9 ndc (product): 68599-5401 ndc11 (package): 68599540109 ndc11 (package): 68599540107 ndc11 (package): 68599540100 ndc11 (package): 68599540101 ndc11 (package): 68599540106 ndc11 (package): 68599540104 ndc11 (package): 68599540102 ndc11 (package): 68599540103 ndc11 (package): 68599540108 ndc11 (package): 68599540105 spl id: 2bd8fbd8-918a-0617-e063-6294a90a6c7e spl set id: 626d7aa9-b8da-4254-9c57-9007ed4290d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.