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 structure8 sections

Contacts and useful links#

PhoneLabel contact1-866-443-4509

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

OTC - QUESTIONS SECTION

Questions?

1-866-443-4509

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79421-001-01	2025-01-30	C162847	48780-1	2cef2736-a4af-d83d-e063-dadaa90ab31f	acc2acbd-b313-e26a-e053-2a95a90a1874

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79421-001-01	American Hand Sanitizer	59 mL in 1 BOTTLE, SPRAY	SPRAY	59		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79421-001	AMERICAN HAND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [AMERICAN HAND SANITIZER, LLC]	1	Legacy NDC, 1 package rows	20200814_acc2acbd-b313-e26a-e053-2a95a90a1874.zip

Products#

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

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

American Hand Sanitizer
BENZALKONIUM CHLORIDE
HYDROGEN PEROXIDE
WATER
BENZALKONIUM
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79421-001	79421-001-01

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
Name	UNII	Kind
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
GLYCERIN	PDC6A3C0OX	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acc2997a-6f4c-1540-e053-2a95a90a98b4			acc2acbd-b313-e26a-e053-2a95a90a1874	2020-08-13	Warnings	Exact identifier spl id: acc2997a-6f4c-1540-e053-2a95a90a98b4 spl set id: acc2acbd-b313-e26a-e053-2a95a90a1874

Reported adverse events (FAERS/openFDA)#

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