FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Biolab International Incorporated
Effective date
2018-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:14

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZETHONIUM CHLORIDE
Label structure9 sections

Storage and handling

Storage: Avoid direct sunlight.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Benzethonium Chloride 0.095%

OTC - PURPOSE SECTION

Purpose

Antiseptic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep it out of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Place a small amount of product in your hand, and rub hands together until dry.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water(EAU), Betaine Anhydrous,PEG-40 Hydrogenated Castor Oil, Phenoxyethanol,Diazolidinyl Urea, Palmitamidopropyltrimonium Chloride, Propylene Glycol, Fragrance(Parfum), Sodium Citric Acid, Disodium EDTA.

STORAGE AND HANDLING SECTION

Storage: Avoid direct sunlight.

INDICATIONS & USAGE SECTION

Uses

Decrease bacteria on hands.

WARNINGS SECTION

WarningsFor external use only.

In case of contact with eyes, rinse immediately with plenty of water. Discontinue use if rash or irritation occurs and consult a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72264-001-012020-01-31C16284748780-19d75b9d0-244f-f424-e053-dadaa90a57ce6a3077a7-7461-e308-e053-2a91aa0a09d6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72264-001-01Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72264-001HAND SANITIZER (BENZETHONIUM CHLORIDE) GEL [BIOLAB INTERNATIONAL INCORPORATED]1Legacy NDC, 1 package rows20180419_6a3077a7-7461-e308-e053-2a91aa0a09d6.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72264-00172264-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
BETAINE3SCV180C9WIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
WATER059QF0KO0RIACT
PALMITAMIDOPROPYLTRIMONIUM CHLORIDEN2U96D202FIACT
DISODIUM HYDROGEN CITRATE6FO62KCQ7AIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

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
6a3077a7-7462-e308-e053-2a91aa0a09d66a3077a7-7461-e308-e053-2a91aa0a09d62018-04-18WarningsExact identifier
spl id: 6a3077a7-7462-e308-e053-2a91aa0a09d6
spl set id: 6a3077a7-7461-e308-e053-2a91aa0a09d6

Reported adverse events (FAERS/openFDA)#

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