FDA.reportPublic FDA data

Vegol Hand Sani

Manufacturer
Grupo Asavalle, S.A. de C.V.
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:49

Label at a glance#

ProductVegol Hand Sani
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

To decrease bacteria on hands.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on hands.

Warnings:

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes,

stop use, and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops.

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 without wiping.

Other information:

SPL UNCLASSIFIED SECTION

Do not store above 105ºF. May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Triethanolamine, polysorbate, Fragrance (Parfume).

Package Labeling: 1L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

Package Labeling: 4L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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
78244-001-012021-07-23C16284748780-1c7ccaba7-2709-fd44-e053-dadaa90aa01bVegol Hand Sani
78244-001-022021-07-23C16284748780-1c7ccaba7-2709-fd44-e053-dadaa90aa01bVegol Hand Sani

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78244-001-01Vegol Hand Sani1000 mL in 1 BOTTLEGEL10001
78244-001-02Vegol Hand Sani4000 mL in 1 BOTTLEGEL40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78244-001VEGOL HAND SANI (ALCOHOL) GEL [GRUPO ASAVALLE, S.A. DE C.V.]1Legacy NDC, 2 package rows20200710_aa07e4aa-11f4-1c4f-e053-2995a90a38ee.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
78244-00178244-001-01, 78244-001-02

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
aa07f024-3259-5c5e-e053-2a95a90aeb0caa07e4aa-11f4-1c4f-e053-2995a90a38ee2020-07-09WarningsExact identifier
spl id: aa07f024-3259-5c5e-e053-2a95a90aeb0c
spl set id: aa07e4aa-11f4-1c4f-e053-2995a90a38ee

Reported adverse events (FAERS/openFDA)#

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