HIBICLENS ® (Chlorhexidine Gluconate solution 4.0% w/v)

Manufacturer: Physicians Total Care, Inc.
Effective date: 2012-09-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:04

Label at a glance#

ProductHibiclens

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure9 sections

Indications and uses

antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub personnel hand wash preoperative skin preparation

Dosage and administration

skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of HIBICLENS 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 HIBICLENS with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly. personnel hand wash. Wet hands...

Storage and handling

store between 20-25°C (68-77°F).

Contacts and useful links#

PhoneLabel contact1-800-843-8497

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient	Purpose
Chlorhexidine gluconate solution 4.0% w/v	Antiseptic

Uses

INDICATIONS & USAGE SECTION

antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease
for skin wound and general skin cleansing
surgical hand scrub
personnel hand wash
preoperative skin preparation

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
as a patient preoperative skin preparation of the head or face
in contact with the meninges
in the genital area
on wounds that involve more than the superficial layers of skin

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 contact occurs in any of these areas, rinse with cold water right away

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs and lasts for 72 hours.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

skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of HIBICLENS 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 HIBICLENS with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
personnel hand wash. Wet hands with water. Dispense about 5mL of HIBICLENS into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
preoperative skin preparation. Apply HIBICLENS liberally to surgical site and swab for at least 2 minutes. Dry with a sterile towel. Repeat. Dry with a sterile towel.

Other information

STORAGE AND HANDLING SECTION

store between 20-25°C (68-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

fragrance, isopropyl alcohol 4% w/v, purified water, Red 40, and other ingredients in a nonalkaline base.

Questions?

OTC - QUESTIONS SECTION

1-800-843-8497

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-3046-1

Principal Display Panel - 236 mL Bottle Label

HIBICLENS^®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial Skin Cleanser

HIBICLENS^® prevents skin infections thereby reducing the risk of cross-
infection. HIBICLENS^® has antiseptic activity and a persistent antimicrobial
effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE^®
HEALTH CARE

8 Fl. oz. (236 mL)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-3046-0	2019-09-24	C162847	48780-1	9350213a-431f-c013-e053-90daa90a1393	HIBICLENS ® (Chlorhexidine Gluconate solution 4.0% w/v)
54868-3046-1	2019-09-24	C162847	48780-1	9350213a-431f-c013-e053-90daa90a1393	HIBICLENS ® (Chlorhexidine Gluconate solution 4.0% w/v)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54868-3046-0	Hibiclens	118 mL in 1 BOTTLE	SOLUTION	118	1
54868-3046-0	Hibiclens	1 in 1 CARTON	SOLUTION	1	1
54868-3046-1	Hibiclens	1 in 1 CARTON	SOLUTION	1	1
54868-3046-1	Hibiclens	236 mL in 1 BOTTLE	SOLUTION	236	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-3046	HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1	4 package rows	20120920_424b8852-87c2-4b53-abab-838c46034a79.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	1
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	1
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Hibiclens
Chlorhexidine gluconate
CHLORHEXIDINE
Isopropyl alcohol
FD&C Red NO. 40
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-3046	54868-3046-0, 54868-3046-1
0234-0575

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
Isopropyl alcohol	ND2M416302	IACT
FD&C Red NO. 40	WZB9127XOA	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C Red NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+dosage form 4 equally ranked IID candidates
FD&C Red NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii+route 4 equally ranked IID candidates
FD&C Red NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii+dosage form 4 equally ranked IID candidates
Isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form
FD&C Red NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii+route 4 equally ranked IID candidates

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
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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N017768-001	HIBICLENS	4%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`c2088c7a36db…`
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…`

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
759ff775-6dc9-46c3-8a45-853f619c19ea			424b8852-87c2-4b53-abab-838c46034a79	2012-09-19	Warnings	Exact identifier spl id: 759ff775-6dc9-46c3-8a45-853f619c19ea spl set id: 424b8852-87c2-4b53-abab-838c46034a79

Reported adverse events (FAERS/openFDA)#

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