FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Washington State University
Effective date
2020-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:36

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

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, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 mL NDC: 74363-001-01 8 oz label8 oz label

354 mL NDC: 74363-001-02 12 oz Label12 oz Label

473 mL NDC: 74363-001-03 16 oz Label16 oz Label

946 mL NDC: 74363-001-04 32 oz Label32 oz Label

100 mL NDC: 74363-001-05 100 mL Label100 mL Label

500 mL NDC: 74363-001-06 500 mL Label500 mL Label

750 mL NDC: 74363-001-07 750 mL Label750 mL Label

1000 mL NDC: 74363-001-08 1000 mL Label1000 mL Label

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74363-001-012022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-022022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-032022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-042022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-052022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-062022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-072022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e
74363-001-082022-01-28C16284748780-1d6a99b39-39ba-a426-e053-dadaa90af4c2a22c4355-d76b-d9a9-e053-2995a90ac51e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74363-001-01Hand Sanitizer237 mL in 1 BOTTLELIQUID2371
74363-001-02Hand Sanitizer354 mL in 1 BOTTLELIQUID3541
74363-001-03Hand Sanitizer473 mL in 1 BOTTLELIQUID4731
74363-001-04Hand Sanitizer946 mL in 1 BOTTLELIQUID9461
74363-001-05Hand Sanitizer100 mL in 1 BOTTLELIQUID1001
74363-001-06Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
74363-001-07Hand Sanitizer750 mL in 1 BOTTLELIQUID7501
74363-001-08Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74363-001HAND SANITIZER (ALCOHOL) LIQUID [WASHINGTON STATE UNIVERSITY]1Legacy NDC, 8 package rows20200401_a22c4355-d76b-d9a9-e053-2995a90ac51e.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
74363-00174363-001-01, 74363-001-02, 74363-001-03, 74363-001-04, 74363-001-05, 74363-001-06, 74363-001-07, 74363-001-08

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
a22c5134-d8a0-a185-e053-2995a90ae0f0a22c4355-d76b-d9a9-e053-2995a90ac51e2020-03-31WarningsExact identifier
spl id: a22c5134-d8a0-a185-e053-2995a90ae0f0
spl set id: a22c4355-d76b-d9a9-e053-2995a90ac51e

Reported adverse events (FAERS/openFDA)#

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