Provon Antimicrobial Foam Handwash

Manufacturer: Xttrium Laboratories, Inc.
Effective date: 2025-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:00:14

Label at a glance#

ProductProvon Antimicrobial Foam Handwash

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure11 sections

Indications and uses

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Dosage and administration

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Healthcare personnel handwash: wet hands with water dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with 5 mL of...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-321-9647

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

chlorhexidine gluconate 2% solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

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 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 solution should contact these areas, rinse out promptly and thoroughly with water
do not use routinely if you have wounds which involve more than the superficial layers of the skin

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.

Healthcare personnel handwash:

wet hands with water
dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly

Surgical hand scrub:

wet hands and forearms with water
scrub for 3 minutes with 5 mL of product (6 full stokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
a seperate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 5 mL of product (6 full strokes) and rinse under running water and dry 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 add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-321-9647 Monday through Friday 8:00 AM to 5:00 PM EST

RECENT MAJOR CHANGES SECTION

Indications and Usage

Dosage and Administration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROVON® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOADXFLBLC

8842-643-F

ADX front

8842

NDC 21749-850-90

Brought to you by GOJO

PROVON ^®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

42 fl oz (1250 mL)

GOJOADXBLBLB

8842-642-B

ADX Back PDP

ADX Back DF1

ADX Back DF2

PROVON ^® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOLTXFLBLC

1922-643-F

LTX front.

1922

NDC 21749-850-89

Brought to you by GOJO

PROVON ^®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

40.5 fl oz (1200 mL)

GOJOLTXBLBLB

1922-642-B

LTX Back PDP

LTX back DF1

LTX back DF2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	PSN	6
1245230	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap	SCD	6
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	SY	6

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0116-8500-89	Provon Antimicrobial Foam Handwash	1200 mL in 1 BOTTLE, DISPENSING	SOLUTION	1200		6
0116-8500-90	Provon Antimicrobial Foam Handwash	1250 mL in 1 BOTTLE, DISPENSING	SOLUTION	1250		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-8500	PROVON ANTIMICROBIAL FOAM HANDWASH (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250503_46dd136c-d569-0450-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Provon Antimicrobial Foam Handwash
Chlorhexidine Gluconate 2%
CITRIC ACID MONOHYDRATE
COCO DIETHANOLAMIDE
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
WATER
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0116-8500	0116-8500-89, 0116-8500-90

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
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
WATER	059QF0KO0R	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
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
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	46dd136c-d569-0450-e054-00144ff8d46c	2025-04-30	Warnings	Exact identifier ndc (package): 0116-8500-89 ndc (package): 0116-8500-90 ndc (product): 0116-8500 ndc11 (package): 00116850089 ndc11 (package): 00116850090 spl id: 340029e6-b385-3a47-e063-6394a90acbc9 spl set id: 46dd136c-d569-0450-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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