Bactoshield CHG

Manufacturer: Xttrium Laboratories, Inc.
Effective date: 2026-04-28
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:55:18

Label at a glance#

ProductBactoshield CHG

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure11 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 with water scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under r...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-548-4873

Websitewww.p65warnings.ca.gov

www.P65Warnings.ca.gov

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

chlorhexidine gluconate 4% solution

Purposes

OTC - PURPOSE SECTION

surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing

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:

This product may cause a sever 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 deadness when instilled in the middle ear through perforated eardrums.
if solution should contact these areas, rinse out prompty 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 with water
scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
a separate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 5 ml of product and rinse under running water
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
dry with a sterile towel
repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing:

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)
void 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

Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM EST

OTHER SAFETY INFORMATION

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bactoshield ® CHG 4%

NDC 11084-815-03

Surgical Scrub

Chlorhexidine Cluconate 4% Solution Antiseptic

Non-sterile Solution

Surgical Scrub

4% CHG

Antimicrobial

For Single-Use

Net Contents: 118 mL (4 fl oz)

REORDER #1344-39

1344-52F(319)

61346

4BACT04BTLLBLD

4BACT04 PDP

4BACT04 DF1

4BACT04 DF2

4BACT04 DF3

Bactoshield ® CHG 4%

NDC 11084-815-34

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Surgical Scrub

4% CHG

Antimicrobial

Net Contents: 473mL (16 fl oz) (1 pt)

REORDER #1344-33

61340

1344-31H(319)

4BACT16BTLLBLE

4BACT16 PDP

4BACT16 DF1

4BACT16 DF2

4BACT16 DF3

Bactoshield ® CHG 4%

NDC 11084-815-24

Surgical Scrub

4% Solution Antiseptic Chlorhexidine Gluconate

Surgical Scrub

4% CHG

Antimicrobial

Net Contents: 32 fl oz (946 mL)

REORDER #1344-24

61341

1344-21H(319)

4BACT32BTLLBLB

4BACT32

Bactoshield ® CHG 4%

NDC 11084-815-08

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Surgical Scrub

4% CHG

Antimicrobial

Net Contents: 128 fl oz (1 Gal) (3.78 Liters)

REORDER #1344-08

1344-06G(319)

51690

4BACT1GLBLB

4BACT1G PDP

4BACT1G DF1

4BACT1G DF2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2186092	Bactoshield 4 % Medicated Liquid Soap	PSN	7
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	7
2186092	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Bactoshield]	SBD	7
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	7
2186092	Bactoshield 4 % Medicated Liquid Soap	SY	7
2186092	Bactoshield 40 MG/ML Medicated Liquid Soap	SY	7
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	7
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	7

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
0116-1344-03	2023-01-30	C162847	48780-1	f386c649-cf06-0266-e053-dadaa90a7c1a	Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz
0116-1344-08	2023-01-30	C162847	48780-1	f386c649-cf06-0266-e053-dadaa90a7c1a	Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz
0116-1344-24	2023-01-30	C162847	48780-1	f386c649-cf06-0266-e053-dadaa90a7c1a	Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz
0116-1344-34	2023-01-30	C162847	48780-1	f386c649-cf06-0266-e053-dadaa90a7c1a	Bactoshield CHG ® 4% Chlorhexidine Gluconate Solution XTT COMP 4oz, 16 oz, 32 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0116-1344-03	Bactoshield CHG	118 mL in 1 BOTTLE	SOLUTION	118	7
0116-1344-08	Bactoshield CHG	3780 mL in 1 BOTTLE	SOLUTION	3780	7
0116-1344-24	Bactoshield CHG	946 mL in 1 BOTTLE	SOLUTION	946	7
0116-1344-34	Bactoshield CHG	473 mL in 1 BOTTLE	SOLUTION	473	7

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Bactoshield CHG
CHLORHEXIDINE GLUCONATE
COCO DIETHANOLAMIDE
GLUCONOLACTONE
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
PEG-75 LANOLIN
WATER
TRIDECYL ALCOHOL
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0116-1344	0116-1344-08, 0116-1344-24, 0116-1344-34, 0116-1344-03

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
COCO DIETHANOLAMIDE	92005F972D	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)	X70SE62ZAR	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
PEG-75 LANOLIN	09179OX7TB	IACT
WATER	059QF0KO0R	IACT
TRIDECYL ALCOHOL	8I9428H868	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
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
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a6403ad-fa5e-2b4a-e054-00144ff8d46c	2026-04-28	Warnings	Exact identifier ndc (package): 0116-1344-34 ndc (package): 0116-1344-03 ndc (package): 0116-1344-24 ndc (package): 0116-1344-08 ndc (product): 0116-1344 ndc11 (package): 00116134403 ndc11 (package): 00116134408 ndc11 (package): 00116134424 ndc11 (package): 00116134434 spl id: 508b4dad-f96f-1979-e063-6394a90aed08 spl set id: 4a6403ad-fa5e-2b4a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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