FDA.reportPublic FDA data

Antimicrobial Foam Handwash

Manufacturer
GOJO Industries, Inc. | Xttrium Laboratories, Inc.
Effective date
2018-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:40

Label at a glance#

ProductAntimicrobial Foam Handwash
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Antiseptic

Directions:/ Mood de Uso:

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Warnings/Precauciones

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

Para Use Externo Únicamente

Alerta De Allergia:

Este producto puede causar un reacción alérgica severa. Los síntomas pueden incluir:

  • sibilancias/dificultad para respirar
  • shock
  • hinchazón facial
  • urticaria
  • sarpullido

En caso de ocurrir alguna reacción alérgica, detenga el uso y busque ayuda de inmediato

Do not use/No debe usante

OTC - DO NOT USE SECTION

If you are allergic to chlorhexidine gluconate or any other ingredients

Si es alérgico al gluconato de chlorhexidina o a cualquier otro ingrediente

When using this product/ Cuando use este producto

OTC - WHEN USING SECTION

Keep out of eyes, ear and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle of the ear through perforated eardrums. If solution should contact these areas, rinse out promptly and thoroughly with water.

Evite el contacto con los ojos, oídos, y boca. Puede causar daño ocular serio y permanente si se coloca o permanece en el ojo durante procedimientos quirúrgicos o puede causar sordera si se instila en el oído medio a través de tímpano perforado. Si la solución llegara a tener contacto con estas àreas, enjuague lo más pronto posible con suficiente agua.

Stop use an ask a doctor if/ Mantengase fuera consulte a su médico si

OTC - ASK DOCTOR SECTION

Irrititation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Reacciones de irritación, sensibilización o reacciones alérgicas aparecen. Estos son signos de una condicíon seria.

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.

En caso de ingestión, busque ayuda médica o contacte al centro de control de intoxicación de inmediato.

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Gluconate/Gluconato de chlorhexidina 20 MG/G

INACTIVE INGREDIENT SECTION

Citric acid, cocamide DEA, hydroxyethlycellulose, isopropyl alcohol, lauramine oxide, aqua

INDICATIONS & USAGE SECTION

Antimicrobial Handwash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorhexidine Gluconate 2% Solution

NDC 21749-416-89

GOJO Industries, Inc

Akron, OH 44309

+330 255-6000

www.GOJO.com

GOJOLTXINTLLBL

Net Wt 1200 mL

LTX PDPLTX PDP

Page 1Page 1

Page 2Page 2

Chlorhexidine Gluconate 2% Solution

NDC 21749-416-90

GOJO Industries, Inc

Akron, OH 44309

+330 255-6000

www.GOJO.com

GOJOADXINTLLBL

Net Wt 1250 mL

ADX PDPADX PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN1
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD1
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21749-416-89Antimicrobial Foam Handwash1200 mL in 1 BOTTLELIQUID12001
21749-416-90Antimicrobial Foam Handwash1250 mL in 1 BOTTLELIQUID12501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-416ANTIMICROBIAL FOAM HANDWASH (CHLORHEXIDINE GLUCONATE 2% SOLUTION) LIQUID [GOJO INDUSTRIES, INC.]1Current NDC, Legacy NDC, 2 package rows20180824_743021cd-38c3-3825-e053-2a91aa0aa7f2.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-41621749-416-89, 21749-416-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)S38J6RZN16IACT
LAURAMINE OXIDE4F6FC4MI8WIACT

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019422-001DYNA-HEX 2CHLORHEXIDINE GLUCONATE2%SOLUTION / TOPICALRLD, RS1985-12-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-1784e616aacf4f…
2026-08-18 06:07:402026-07N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.743021cd-38c3-3825-e053-2a91aa0aa7f22018-08-24WarningsExact identifier
ndc (package): 21749-416-89
ndc (package): 21749-416-90
ndc (product): 21749-416
ndc11 (package): 21749041689
ndc11 (package): 21749041690
spl id: 743021cd-38c4-3825-e053-2a91aa0aa7f2
spl set id: 743021cd-38c3-3825-e053-2a91aa0aa7f2

Reported adverse events (FAERS/openFDA)#

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