FDA.reportPublic FDA data

American Hand Sanitizer

Manufacturer
American Hand Sanitizer, LLC | Denison Pharmaceuticals, LLC
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:40

Label at a glance#

ProductAmerican Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Anitseptic

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria and viruses on the skin.

Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop it and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Read the entire label before using this product.

Pump a small amount of liquid into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 2label 2label 3label 3labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79421-002-012025-01-30C16284748780-12cef2736-7cd3-d83d-e063-dadaa90ab31facc410b4-e9c2-0dd8-e053-2a95a90a50b0
79421-002-022025-01-30C16284748780-12cef2736-7cd3-d83d-e063-dadaa90ab31facc410b4-e9c2-0dd8-e053-2a95a90a50b0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79421-002-01American Hand Sanitizer3785 mL in 1 JUGLIQUID37851
79421-002-02American Hand Sanitizer150 mL in 1 CONTAINERLIQUID1501
79421-002-02American Hand Sanitizer100 in 1 CONTAINERLIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79421-002AMERICAN HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [AMERICAN HAND SANITIZER, LLC]1Legacy NDC, 3 package rows20200814_acc410b4-e9c2-0dd8-e053-2a95a90a50b0.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79421-00279421-002-01, 79421-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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
acc3f45d-2a83-53c5-e053-2995a90afb40acc410b4-e9c2-0dd8-e053-2a95a90a50b02020-08-13WarningsExact identifier
spl id: acc3f45d-2a83-53c5-e053-2995a90afb40
spl set id: acc410b4-e9c2-0dd8-e053-2a95a90a50b0

Reported adverse events (FAERS/openFDA)#

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