FDA.reportPublic FDA data

American Hand Sanitizer

Manufacturer
American Hand Sanitizer LLC
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:42

Label at a glance#

ProductAmerican Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Read the entire label before using this product. Pump a small amout of liquid into palm of hand. Rub thoroughly over all surfaces on both hands for 15 seconds

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of contact with flush eyes with water.

OTC - STOP USE SECTION

Stop use 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Read the entire label before using this product.
  • Pump a small amout of liquid into palm of hand.
  • Rub thoroughly over all surfaces on both hands for 15 seconds

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79421-003-012022-01-28C16284748780-1d6a99b39-c781-a426-e053-dadaa90af4c2American Hand Sanitizer Liquid 80
79421-003-022022-01-28C16284748780-1d6a99b39-c781-a426-e053-dadaa90af4c2American Hand Sanitizer Liquid 80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79421-003-01American Hand Sanitizer150 mL in 1 CONTAINERLIQUID1501
79421-003-02American Hand Sanitizer3785 mL in 1 JUGLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79421-003AMERICAN HAND SANITIZER (ALCOHOL) LIQUID [AMERICAN HAND SANITIZER LLC]1Legacy NDC, 2 package rows20200814_acc934a8-3594-d520-e053-2995a90a244d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79421-00379421-003-01, 79421-003-02

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
acc9163e-a7b4-df57-e053-2a95a90a586eacc934a8-3594-d520-e053-2995a90a244d2020-08-13WarningsExact identifier
spl id: acc9163e-a7b4-df57-e053-2a95a90a586e
spl set id: acc934a8-3594-d520-e053-2995a90a244d

Reported adverse events (FAERS/openFDA)#

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