Hibiclens for Georgia Pacific

Manufacturer: Georgia-Pacific Consumer Products LP
Effective date: 2022-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:52:30

Label at a glance#

ProductHibiclens for Georgia Pacific

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure13 sections

Indications and uses

antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease surgical hand scrub healthcare personnel 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. surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5mL (8 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly. healthcare personnel handwash. Wet hands with water. Dispense about 5mL (8 pumps) of the product into...

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution 4% w/v

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease
surgical hand scrub
healthcare personnel handwash

Warnings

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

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
do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

OTC - ASK DOCTOR 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 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.
surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5mL (8 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
healthcare personnel handwash. Wet hands with water. Dispense about 5mL (8 pumps) 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 ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

54622-575-73_Drug Facts and PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	2
834167	HIBICLENS 4 % Medicated Liquid Soap	PSN	2
834167	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]	SBD	2
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	2
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	2
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	2
834167	Hibiclens 4 % Medicated Liquid Soap	SY	2

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
54622-575-73	2024-01-30	C162847	48780-1	1030e365-5080-111a-e063-dadaa90a10e2	Hibiclens for Georgia Pacific

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54622-575-73	Hibiclens for Georgia Pacific	1200 mL in 1 BOTTLE, DISPENSING	SOLUTION	1200		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54622-575	HIBICLENS FOR GEORGIA PACIFIC (CHLORHEXIDINE GLUCONATE) SOLUTION [GEORGIA-PACIFIC CONSUMER PRODUCTS LP]	2	Legacy NDC, 1 package rows	20221217_d9a397a0-9484-34ef-e053-2995a90a642b.zip

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54622-575	54622-575-73

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
efe2af77-c6c9-27e3-e053-2a95a90ad1ec			d9a397a0-9484-34ef-e053-2995a90a642b	2022-12-15	Warnings	Exact identifier spl id: efe2af77-c6c9-27e3-e053-2a95a90ad1ec spl set id: d9a397a0-9484-34ef-e053-2995a90a642b

Reported adverse events (FAERS/openFDA)#

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