Hibiclens

Manufacturer: Asclemed USA, Inc.
Effective date: 2024-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:39:26

Label at a glance#

ProductHibiclens

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure14 sections

Indications and uses

antimicrobial skin cleanser helps to reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare peronnel handwash

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly. surgical hand scrub . Wet hands and forearms with water. Scrub for 3 minutes with ab...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-843-8497

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution 4.0% w/v

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

antimicrobial skin cleanser helps to reduce bacteria that potentially can cause disease
for skin wound and general skin cleansing
surgical hand scrub
healthcare peronnel handwash

WARNINGS SECTION

For external use only

Allergy alert:

WARNINGS 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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
in contact with the 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 contact occurs in any of these areas, rinse with cold water right away
wounds which involve more than the superficial layers of the skin should not be routinely treated
repeated general cleansing of large body areas should not be done except when advised by a health care provider

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

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.
skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly.
surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
healthcare personnel handwash. Wet hand with water. Dispense about 5mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Other information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40

Questions?

OTC - QUESTIONS SECTION

1-800-843-8497

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	3
834167	HIBICLENS 4 % Medicated Liquid Soap	PSN	3
834167	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]	SBD	3
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	3
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	3
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	3
834167	Hibiclens 4 % Medicated Liquid Soap	SY	3

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	Strength	SPL version
76420-535-08	Hibiclens	236 mL in 1 BOTTLE	SOLUTION	236		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-535	HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [ASCLEMED USA, INC.]	3	Current NDC, 1 package rows	20241127_c7363108-0b4e-4d8a-9ec8-ea048604ecb2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-535-08	ML - Milliliter	76420-535	304f2a5d-fca7-4ee7-86cd-f8f7741f217f	1	2023-03-13
0234-0575-04	ML - Milliliter	0234-0575	2c7f09fc-94c5-4fc5-b48c-71188619df18	1	2012-07-24
0234-0575-08	ML - Milliliter	0234-0575	9eea668e-5fde-456f-a7ee-3251bffca1c5	1	2012-07-24
0234-0575-16	ML - Milliliter	0234-0575	0cc2b373-1d80-4637-99b6-75fb80ba95a2	1	2012-07-24
0234-0575-17	ML - Milliliter	0234-0575	94926e3b-31c8-456c-8dea-5c4ed2b69cdd	1	2012-07-24
0234-0575-32	ML - Milliliter	0234-0575	588c6c29-dfd9-40e4-ba05-8544184bdfca	1	2012-07-24
0234-0575-40	ML - Milliliter	0234-0575	b49c8b95-df57-4aea-b30b-e4892191a037	1	2017-11-06
0234-0575-41	ML - Milliliter	0234-0575	2d7ae4b3-648f-4ab7-bb82-dca7abcd265c	1	2019-12-10
0234-0575-80	ML - Milliliter	0234-0575	d0508c6d-a36c-46d0-be06-7f8f2d689bb7	1	2026-04-20
0234-0575-91	ML - Milliliter	0234-0575	7ea5bf35-011c-4299-a7e2-29b0c6ecbb6e	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Hibiclens
Chlorhexidine Gluconate
POLOXAMER 237
GLUCONOLACTONE
LAURAMINE OXIDE
ISOPROPYL ALCOHOL
WATER
FD&C RED NO. 40
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76420-535	76420-535-08
0234-0575

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLOXAMER 237	JT3U72U71K	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
WATER	059QF0KO0R	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB

Source Document#

Source XML

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
N017768-001	HIBICLENS	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	29b547bf-c08e-14c2-e054-00144ff88e88	2024-12-23	Warnings	Exact identifier ndc (product): 0234-0575
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	4275eb53-1a7e-4a91-aac1-1085f40fac88	2024-12-23	Warnings	Exact identifier ndc (product): 0234-0575
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	8b37a721-79bb-4051-95a7-fcb4edebfcb7	2024-12-23	Warnings	Exact identifier ndc (product): 0234-0575
Hibiclens	CHLORHEXIDINE GLUCONATE	Asclemed USA, Inc.	c7363108-0b4e-4d8a-9ec8-ea048604ecb2	2024-10-05	Warnings	Exact identifier ndc (package): 76420-535-08 ndc (product): 76420-535 ndc11 (package): 76420053508 spl id: 23b4100e-49d1-0cb6-e063-6394a90a9d24 spl set id: c7363108-0b4e-4d8a-9ec8-ea048604ecb2

Reported adverse events (FAERS/openFDA)#

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