FDA.reportPublic FDA data

Viragel Hand Sanitizer

Manufacturer
Comercial Emana, S.A. de C.V.
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:08

Label at a glance#

ProductViragel Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry.  Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose:

OTC - PURPOSE SECTION

Antimicrobial

Use:

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

Warnings:

WARNINGS SECTION

Flammable, Keep away from fire or flame.

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact , rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry.  Children under 6 years of age should be supervised when using this product.

Other information:

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C ) may discolor certain fabrics or surfaces

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Carbomer, Triethanolamine, Alpha-Tocopherol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BolttleBolttle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80007-001-012022-01-28C16284748780-1d6a99b39-93d5-a426-e053-dadaa90af4c2Viragel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80007-001-01Viragel Hand Sanitizer2 mL in 1 PACKETGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80007-001VIRAGEL HAND SANITIZER (ALCOHOL) GEL [COMERCIAL EMANA, S.A. DE C.V.]1Legacy NDC, 1 package rows20200828_eb223fde-196f-448f-a64a-010fec5f20cc.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80007-00180007-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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
addf3834-9029-a723-e053-2995a90a9fd6eb223fde-196f-448f-a64a-010fec5f20cc2020-08-27WarningsExact identifier
spl id: addf3834-9029-a723-e053-2995a90a9fd6
spl set id: eb223fde-196f-448f-a64a-010fec5f20cc

Reported adverse events (FAERS/openFDA)#

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