Antiseptic Skin Cleanser

Manufacturer: Xttrium Laboratories, Inc.
Effective date: 2026-03-03
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:50:26

Label at a glance#

ProductAntiseptic Skin Cleanser

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure10 sections

Indications and uses

healthcare personnel handwash : helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-587-3721

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% Solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
skin wound and general skin cleansing

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
in contact with meninges
in the genital area

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
wound 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 advised by a health care provider

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Direction

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:

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

Skin wound and general skin cleansing:

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-587-3721

RECENT MAJOR CHANGES SECTION

Uses

Doseage and Adminisration

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-08

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

8 fl oz (237 mL)

4CVS08BTLLBLG

8oz CVS single panel

CVS

Compare to the active ingredient in Hibiclens®

NDC 59779-767-08

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

8 fl oz (237 mL)

4CVS08LBL4CAE

8 oz CA label

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-16

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

16 fl oz (473 mL)

4CVS16BTLLBLB

16oz CVS single panel

CVS

Compare to the active ingredient in Hibiclens®

NDC 59779-767-16

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

16 fl oz (473 mL)

4CVS16LBL4CAD

16 oz CA

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-18

FOAMING

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

Clinically proven to reduce bacteria on skin

18 fl oz (532 mL)

For external use only

4CVS18FMBTLLBLA

18oz CVS single panel

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-18

FOAMING

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

Clinically proven to reduce bacteria on skin

18 fl oz (532 mL)

For external use only

4CVS18FMLBLCAA

18oz CVS CA single panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	12
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	12
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	12
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	12

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0050428143032	GTIN-13: 0050428143032 EAN-13: 0050428143032 GTIN-12: 050428143032 UPC-A: 050428143032 GTIN storage (14 digits): 00050428143032	8oz CA.jpg
Barcode	EAN-13	0050428339411	GTIN-13: 0050428339411 EAN-13: 0050428339411 GTIN-12: 050428339411 UPC-A: 050428339411 GTIN storage (14 digits): 00050428339411	16 oz CA label.jpg

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
0116-0767-08	Antiseptic Skin Cleanser	237 mL in 1 BOTTLE	LIQUID	237	12
0116-0767-16	Antiseptic Skin Cleanser	473 mL in 1 BOTTLE	LIQUID	473	12
0116-0767-18	Antiseptic Skin Cleanser	532 mL in 1 BOTTLE, PUMP	LIQUID	532	12

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Antiseptic Skin Cleanser
CHLORHEXIDINE GLUCONATE 4%
GLUCONOLACTONE
PEG-75 LANOLIN
TRIDECYL ALCOHOL
COCO DIETHANOLAMIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
WATER
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0116-0767	0116-0767-08, 0116-0767-16, 0116-0767-18

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
GLUCONOLACTONE	WQ29KQ9POT	IACT
PEG-75 LANOLIN	09179OX7TB	IACT
TRIDECYL ALCOHOL	8I9428H868	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	S38J6RZN16	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
WATER	059QF0KO0R	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
11	2025-12-08	monthly-update	2026-06-03 17:45:33

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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`f41ea6bd6efb…`

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 4%	Xttrium Laboratories, Inc.	48a814e7-bfe4-5437-e054-00144ff88e88	2026-03-03	Warnings	Exact identifier ndc (package): 0116-0767-16 ndc (package): 0116-0767-08 ndc (package): 0116-0767-18 ndc (product): 0116-0767 ndc11 (package): 00116076716 ndc11 (package): 00116076708 ndc11 (package): 00116076718 spl id: 4c21b269-c2e0-8b47-e063-6294a90a37c2 spl set id: 48a814e7-bfe4-5437-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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