FDA.reportPublic FDA data

BV BYE VIRUS HAND SANITIZER GEL

Manufacturer
COMERCIAL GOURA,S. DE R.L.
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:21:11

Label at a glance#

ProductBV BYE VIRUS 99
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised when using.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Children under 6 years of age should be supervised when using.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Store below 110°F (43°C)

Children under 6 years of age should be supervised when using.

WARNINGS

WARNINGS SECTION

Warnings

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredienT Ethyl Alcohol 70% v/v…

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Carbomer, Triethanolamine

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

OTC - STOP USE SECTION

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

PURPOSE

OTC - PURPOSE SECTION

PURPOSE ANTIMICROBIAL

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Use[s]

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

PACKAGE LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mL BYE VIRUSLABEL 250 mL BYE VIRUSLABEL 500 mL BYE VIRUSLABEL 500 mL BYE VIRUSLABEL 1000 mL BYE VIRUSLABEL 1000 mL BYE VIRUSLABEL 19000 mL BYE VIRUSLABEL 19000 mL BYE VIRUSLABEL 30 mLLABEL 30 mLLABEL 60 mLLABEL 60 mLLABEL 125 mLLABEL 125 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78501-4000-12022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-22022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-42022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-52022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-62022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-72022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-82022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL
78501-4000-92022-01-28C16284748780-1d6a99b39-ddc6-a426-e053-dadaa90af4c2BV BYE VIRUS HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78501-4000-1BV BYE VIRUS 9919000 mL in 1 PAILGEL190002
78501-4000-2BV BYE VIRUS 994000 mL in 1 JUGGEL40002
78501-4000-4BV BYE VIRUS 9960 mL in 1 BOTTLEGEL602
78501-4000-5BV BYE VIRUS 9930 mL in 1 BOTTLEGEL302
78501-4000-6BV BYE VIRUS 99125 mL in 1 BOTTLEGEL1252
78501-4000-7BV BYE VIRUS 99250 mL in 1 BOTTLEGEL2502
78501-4000-8BV BYE VIRUS 99500 mL in 1 BOTTLEGEL5002
78501-4000-9BV BYE VIRUS 991000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78501-4000BV BYE VIRUS 99 (ETHYL ALCOHOL) GEL [COMERCIAL GOURA,S. DE R.L.]2Legacy NDC, 8 package rows20200714_a9338a30-77a3-404e-e053-2a95a90a2bf9.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78501-400078501-4000-4, 78501-4000-5, 78501-4000-6, 78501-4000-7, 78501-4000-8, 78501-4000-9, 78501-4000-1, 78501-4000-2

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
GLYCERINPDC6A3C0OXIACT

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
aa58fdcb-cb60-ec70-e053-2a95a90ae5c5a9338a30-77a3-404e-e053-2a95a90a2bf92020-07-13WarningsExact identifier
spl id: aa58fdcb-cb60-ec70-e053-2a95a90ae5c5
spl set id: a9338a30-77a3-404e-e053-2a95a90a2bf9

Reported adverse events (FAERS/openFDA)#

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