FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Virus Protection Systems LLC | VIRUS PROTECTION SYSTEMS, LLC
Effective date
2020-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:48

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product and rub together and allow to dry without wiping

Storage and handling

Store below 105 fahrenheit May discolor some fabrics

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 (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (.4% v/v).
  3. Hydrogen peroxide (0.4% 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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand-washing to decrease bacteria on the skin if soap and water is not available

Back of BottleBack of Bottle

Warnings

WARNINGS SECTION

Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

in or near the eyes

OTC - WHEN USING SECTION



Stop use and ask a doctor if irritation or redness develop.

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 redness.

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

  • Wet hands thoroughly with product and rub together and allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

  • Store below 105 fahrenheit
  • May discolor some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, carbomer, triethanolamine, denatonium, benzoate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Steve Madden

Hand Sanitizer

70% Alchohol

30 ml NDC: 74707-001-03

Front of BottleFront of Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74707-001-032022-01-28C16284748780-1d6a99b39-5927-a426-e053-dadaa90af4c2Steve Madden Label 70% Alchohol Hand Sanitizer, 30ML

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74707-001-03Hand Sanitizer30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74707-001HAND SANITIZER (ALCOHOL) LIQUID [VIRUS PROTECTION SYSTEMS LLC]1Legacy NDC, 1 package rows20200527_a684d719-2006-7586-e053-2995a90aae94.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
74707-00174707-001-03

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
a684d1a4-5569-c686-e053-2a95a90ae586a684d719-2006-7586-e053-2995a90aae942020-05-25WarningsExact identifier
spl id: a684d1a4-5569-c686-e053-2a95a90ae586
spl set id: a684d719-2006-7586-e053-2995a90aae94

Reported adverse events (FAERS/openFDA)#

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