FDA.reportPublic FDA data

Hand Sanitiser

Manufacturer
WESTBARNCO LTD
Effective date
2020-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:23

Label at a glance#

ProductHand Sanitiser
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 67% w/w

Drug FactsDrug Facts

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitiser spray 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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

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

INSTRUCTIONS FOR USE SECTION

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

• Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage

DOSAGE & ADMINISTRATION SECTION

wet hands thoroughly with product and allow to dry without wiping

Other Information

OTHER SAFETY INFORMATION

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mentha piperita leaf water, Glycerin, Mentha piperita oil, Eucalyptus globulus leaf oil, Phenoxyethanol, Ethylhexylglycerin, Limonene, CI 42090, CI 16035.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ml. 76916-167-15

50ml Label50ml Label

DirectionsDirections

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200ml. 76916-167-12

200ml Label.200ml Label.Directions.Directions.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76916-167-122022-01-28C16284748780-1d6a99b39-66d9-a426-e053-dadaa90af4c2a442a4cd-95d2-038a-e053-2a95a90aa5e8
76916-167-152022-01-28C16284748780-1d6a99b39-66d9-a426-e053-dadaa90af4c2a442a4cd-95d2-038a-e053-2a95a90aa5e8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76916-167-12Hand Sanitiser200 mL in 1 BOTTLESPRAY2002
76916-167-15Hand Sanitiser50 mL in 1 BOTTLE, SPRAYSPRAY502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76916-167HAND SANITISER (ISOPROPYL ALCOHOL) SPRAY [WESTBARNCO LTD]2Legacy NDC, 2 package rows20201217_a442a4cd-95d2-038a-e053-2a95a90aa5e8.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76916-16776916-167-15, 76916-167-12

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
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
EUCALYPTUS OIL2R04ONI662IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MENTHA PIPERITA LEAFA389O33LX6IACT

Source Document#

Source XML · Source PDF

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
b696ab62-bc1e-2649-e053-2a95a90a5e59a442a4cd-95d2-038a-e053-2a95a90aa5e82020-12-16WarningsExact identifier
spl id: b696ab62-bc1e-2649-e053-2a95a90a5e59
spl set id: a442a4cd-95d2-038a-e053-2a95a90aa5e8

Reported adverse events (FAERS/openFDA)#

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