Purell Antimicrobial Foam

Manufacturer
GOJO Industries, Inc. | Xttrium Laboratories, Inc.
Effective date
2019-06-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:43

Label at a glance#

ProductPurell Antimicrobial Foam
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure13 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 two months of age. These products may cuase 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 rinse and dry thoroughly Surgical hand scrub wet hands and forearms with water scrub for 3 minutes with 5 mL of product (6 full strokes...

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

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 allergy reaction occurs, stop use and seek madical help right away.

Do not use

OTC - DO NOT USE SECTION

If you are allerigic 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 invlove more than the superficial layers of the skin

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

irritation, sensitization, or allerigic reaction occurs. 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 two months of age. These products may cuase 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

rinse and dry thoroughly

Surgical hand scrub

wet hands and forearms with water

scrub for 3 minutes with 5 mL of product (6 full strokes), 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

SPL UNCLASSIFIED SECTION

store at 20-25ºC (68-77ºF)

avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 21749-225-53

Purell

FOAM HANDWASH

Chlorhexidine Gluconate 2% Solution - Antiseptic

Broad spectrum kill

Gentle on hands

2% CHG ANTIMICROBIAL FOAM

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

800-321-9647 • 330-255-6000

www.GOJO.com

©2019. GOJO Industries, Inc.

All rights reserved., Made in U.S.A.

Reorder 5742-06

GOJOBLUE18LBLB

5742-643

GOJOBLUE18 PDPGOJOBLUE18 PDP

GOJOBLUE18 Drug FactsGOJOBLUE18 Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN3
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD3
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY3

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
21749-225-53Purell Antimicrobial Foam535 mL in 1 BOTTLELIQUID5353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-225PURELL ANTIMICROBIAL FOAM (CHLORHEXIDINE GLUCONATE 2% SOLUTION) LIQUID [GOJO INDUSTRIES, INC.]3Current NDC, Legacy NDC, 1 package rows20190619_6e0f3d2f-7834-68a0-e053-2991aa0ab453.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-22521749-225-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Purell Antimicrobial FoamCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.6c7e63c2-428b-2be2-e053-2a91aa0a6af32024-12-21WarningsExact identifier
ndc (product): 21749-225
Purell Antimicrobial FoamCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.6e0f3d2f-7834-68a0-e053-2991aa0ab4532019-06-18WarningsExact identifier
ndc (package): 21749-225-53
ndc (product): 21749-225
ndc11 (package): 21749022553
spl id: 8ba00543-347d-ac42-e053-2a95a90ae897
spl set id: 6e0f3d2f-7834-68a0-e053-2991aa0ab453

Reported adverse events (FAERS/openFDA)#

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