Bactoshield CHG Chlorhexidine Gluconate Solution

Manufacturer: SC Johnson Professional USA, Inc. | Xttrium Laboratories, Inc.
Effective date: 2022-11-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:27:46

Label at a glance#

ProductBactoshield CHG Chlorhexidine Gluconate

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure10 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: 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 and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner. scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rinse thoroughly under ru...

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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 2% 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: 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 or the patient is allergic to chlorhexidine gluconate or any other ingredient 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 advised by a health care provider

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation, 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.

Surgical hand scrub

SPL UNCLASSIFIED SECTION

wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
rinse thoroughly under running water for 30 seconds
wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
dry thoroughly

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

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

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-587-3721

Monday through Friday 8:00 AM to 4:30 PM CST

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bactoshield^®
CHG 2%

Surgical Scrub
Chlorhexidine Gluconate 2% Solution Antiseptic
Non-Sterile Solution

SCJ PROFESSIONAL
HEALTHCARE

NDC 11084-038-03

Surgical Scrub

2% CHG

Antimicrobial

REORDER #
1322-39

SAP # 4000011062
1322-52J(622)
2SCJ04BTLLBL

deb
SKIN CARE

Net Contents:
4 fl oz (118 mL)

For Single Use

Principal Display Panel - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2196992	Bactoshield 2 % Medicated Liquid Soap	PSN	2
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	PSN	2
2196992	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Bactoshield]	SBD	2
1245230	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap	SCD	2
2196992	Bactoshield 20 MG/ML Medicated Liquid Soap	SY	2
1245230	chlorhexidine gluconate 2 % 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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0691240062004	GTIN-13: 0691240062004 EAN-13: 0691240062004 GTIN-12: 691240062004 UPC-A: 691240062004 GTIN storage (14 digits): 00691240062004	bactoshield-01.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	Strength	SPL version
11084-038-03	Bactoshield CHGChlorhexidine Gluconate	118 mL in 1 BOTTLE	SOLUTION	118		2

Products#

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

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

Bactoshield CHG Chlorhexidine Gluconate
Chlorhexidine Gluconate
CHLORHEXIDINE
CITRIC ACID MONOHYDRATE
COCO DIETHANOLAMIDE
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11084-038	11084-038-03

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
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
WATER	059QF0KO0R	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
N019422-001	DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	2%	SOLUTION / TOPICAL		RLD, RS	1985-12-17

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019422-001	DYNA-HEX 2	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019422-001	DYNA-HEX 2	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`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
Bactoshield CHG Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	46084e90-6ffa-4e1a-a8ff-1c1b1484fe88	2022-11-28	Warnings	Exact identifier ndc (package): 11084-038-03 ndc (product): 11084-038 ndc11 (package): 11084003803 spl id: d0bdb7f6-27d8-43c0-98c3-1e2c1862c00e spl set id: 46084e90-6ffa-4e1a-a8ff-1c1b1484fe88

Reported adverse events (FAERS/openFDA)#

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