CHLORHEXIDINE GLUCONATE

Manufacturer: Rising Pharma Holdings, Inc.
Effective date: 2026-02-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:47:18

Label at a glance#

ProductCHLORHEXIDINE GLUCONATE

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure9 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: handwash to help reduce bacteria that potentially can cause disease skin wound and general skin cleanser: helps reduce bacteria on the skin

Dosage and administration

use with care in premature infants or infants under 2 months of age. These product may cause irritation or chemical burns. use full strength do not dilute Surgical hand scrub: remove jewelry wet hands and forearms with water and apply 5 mL of the product wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces rinse thoroughly with water wash for an ad...

Contacts and useful links#

PhoneLabel contact1-884-874-7464

Websitewww.p65warnings.ca.gov

www.P65Warnings.ca.gov

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution, 4%

Purposes

OTC - PURPOSE SECTION

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

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: handwash to help reduce bacteria that potentially can cause disease
skin wound and general skin cleanser: helps reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Allergy Alert

OTHER SAFETY INFORMATION

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 are allergic to chlorhexidine gluconate or any other ingredients in this preparation
as a patient properative skin preparation (especially on the head or face)
in contact with 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 placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums
if contact occurs, rinse with cold water right away
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 underlying condition makes it necessary to reduce the bacterial population of the skin

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. 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 product may cause irritation or chemical burns.
use full strength
do not dilute

Surgical hand scrub:

remove jewelry
wet hands and forearms with water and apply 5 mL of the product
wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
rinse thoroughly with water
wash for an additional 3 minutes with 5 mL of the product and rinse under running water
dry thoroughly

Healthcare personnel handwash:

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
rinse and dry thoroughly

Skin wound and general skin cleanser:

thoroughly rinse the area to be cleansed with water
apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
rinse again thoroughly

Other information

REFERENCES SECTION

store between 20-25 °C (68-77°F)
avoid excessive heat (above 104°F/40°C)
for additional information, see Safety Data Sheet (SDS)
if swallowed get medical help or contact a Poison Control Center immediately

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water *contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-884-874-7464 Monday through Friday 8:00 AM to 5:00 PM EST

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

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Keep from freezing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-12; 118 mL in 1 BOTTLE

Chlhex-Glu-Sol-118ml-1

Chlhex-Glu-Sol-118ml-2

Chlhex-Glu-Sol-118ml-3

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-24; 236 mL in 1 BOTTLE

Chlhex-Glu-Sol-236ml-1

Chlhex-Glu-Sol-236ml-2

Chlhex-Glu-Sol-236ml-3

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-48; 473 mL in 1 BOTTLE

Chlhex-Glu-Sol-473ml

Chlorhexidine Gluconate Liquid Solution

NDC:16571-111-95; 946 mL in 1 BOTTLE

Chlhex-Glu-Sol-946ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	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

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	0316571111480	GTIN-13: 0316571111480 EAN-13: 0316571111480 GTIN-12: 316571111480 UPC-A: 316571111480 GTIN storage (14 digits): 00316571111480	Chlhex-Glu-Sol-473ml.jpg
Barcode	EAN-13	0316571111954	GTIN-13: 0316571111954 EAN-13: 0316571111954 GTIN-12: 316571111954 UPC-A: 316571111954 GTIN storage (14 digits): 00316571111954	Chlhex-Glu-Sol-946ml.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16571-111-12	CHLORHEXIDINE GLUCONATE	118 mL in 1 BOTTLE	SOLUTION	118	2
16571-111-24	CHLORHEXIDINE GLUCONATE	237 mL in 1 BOTTLE	SOLUTION	237	2
16571-111-48	CHLORHEXIDINE GLUCONATE	473 mL in 1 BOTTLE	SOLUTION	473	2
16571-111-95	CHLORHEXIDINE GLUCONATE	946 mL in 1 BOTTLE	SOLUTION	946	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-111-12	ML - Milliliter	16571-111	1c9d4c79-a01e-4107-892b-f2b9d5d2dad5	1	2023-10-16
16571-111-24	ML - Milliliter	16571-111	6d2ea62d-ca53-4597-a5a4-110381f73236	1	2023-10-16
16571-111-48	ML - Milliliter	16571-111	9d1f8237-5258-43af-be1a-6e0dd8a29a2d	1	2023-10-16

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

CHLORHEXIDINE GLUCONATE
COCAMINE OXIDE
CHLORHEXIDINE
GLUCONOLACTONE
PEG-75 LANOLIN
PROPYLENE GLYCOL
COCO DIETHANOLAMIDE
GLUCONIC ACID
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%)
PEG-150 DISTEARATE
QUATERNIUM-33
ISOPROPYL ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16571-111	16571-111-12, 16571-111-24, 16571-111-48, 16571-111-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCAMINE OXIDE	QWA2IZI6FI	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
GLUCONOLACTONE	WQ29KQ9POT	IACT
PEG-75 LANOLIN	09179OX7TB	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
GLUCONIC ACID	R4R8J0Q44B	IACT
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%)	7Q6P4JN1QT	IACT
PEG-150 DISTEARATE	6F36Q0I0AC	IACT
QUATERNIUM-33	XPS4174QZJ	IACT
ISOPROPYL ALCOHOL	ND2M416302	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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019258-001	CIDA-STAT	CHLORHEXIDINE GLUCONATE	2%	SOLUTION / TOPICAL			1986-07-22
N019258-002	CHG SCRUB	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL			1986-07-22

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`4b0b4de00fa7…`

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
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Rising Pharma Holdings, Inc.	d53a01eb-7213-4f19-b74f-acbf0fd54418	2026-02-10	Warnings	Exact identifier ndc (package): 16571-111-12 ndc (package): 16571-111-24 ndc (package): 16571-111-95 ndc (package): 16571-111-48 ndc (product): 16571-111 ndc11 (package): 16571011124 ndc11 (package): 16571011112 ndc11 (package): 16571011195 ndc11 (package): 16571011148 spl id: 32cca440-c887-49ab-9c52-0b43fdf87b78 spl set id: d53a01eb-7213-4f19-b74f-acbf0fd54418

Reported adverse events (FAERS/openFDA)#

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