FDA.reportPublic FDA data

Varigard Hand Sanitizer

Manufacturer
VARIGARD, LLC
Effective date
2022-12-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:35

Label at a glance#

ProductVarigard Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

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

Storage and handling

Store between 0-40ºC (32-104ºF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

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 appears and lasts.

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Store between 0-40ºC (32-104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alginate, Glycerin, Hydrogen Peroxide, Purified Water USP

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN4
581660ethanol 0.62 ML/ML Topical GelSCD4
581660ethanol 62 % Topical GelSY4

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
80787-001-012024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2
80787-001-022024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2
80787-001-032024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2
80787-001-042024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2
80787-001-052024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2
80787-001-062024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2
80787-001-072024-01-30C16284748780-11030e365-0139-111a-e063-dadaa90a10e267cb8e07-0af6-4268-9d36-477e006abba2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80787-001-01Varigard Hand Sanitizer59 mL in 1 CONTAINERGEL594
80787-001-02Varigard Hand Sanitizer118 mL in 1 CONTAINERGEL1184
80787-001-03Varigard Hand Sanitizer236 mL in 1 CONTAINERGEL2364
80787-001-04Varigard Hand Sanitizer946 mL in 1 CONTAINERGEL9464
80787-001-05Varigard Hand Sanitizer3785 mL in 1 CONTAINERGEL37854
80787-001-06Varigard Hand Sanitizer208175 mL in 1 DRUMGEL2081754
80787-001-07Varigard Hand Sanitizer1040875 mL in 1 DRUMGEL10408754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80787-001VARIGARD HAND SANITIZER (ALCOHOL) GEL [VARIGARD, LLC]4Legacy NDC, 7 package rows20221223_67cb8e07-0af6-4268-9d36-477e006abba2.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
80787-00180787-001-01, 80787-001-02, 80787-001-03, 80787-001-04, 80787-001-05, 80787-001-06, 80787-001-07

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
f0701d36-06d7-60c1-e053-2a95a90a1eac67cb8e07-0af6-4268-9d36-477e006abba22022-12-22WarningsExact identifier
spl id: f0701d36-06d7-60c1-e053-2a95a90a1eac
spl set id: 67cb8e07-0af6-4268-9d36-477e006abba2

Reported adverse events (FAERS/openFDA)#

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