FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Wessco International
Effective date
2020-07-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:09

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Storage and handling

Other information: Store below 110︒F(43︒C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Uses: to help reduce germs on the skin

WARNINGS SECTION

Warnings: For external use only, Flammable, Keep away from fire or flame

OTC - WHEN USING SECTION

When using this product: avoid contact with eyes, if contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop using and ask a doctor: if irritation or redness develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: In case of accidental ingetion, get medical help or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions: Squeeze a significant amount in your palm and rub hands until fully dry. Rinse free.

STORAGE AND HANDLING SECTION

Other information: Store below 110︒F(43︒C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol，Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

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
42509-034-012025-01-30C16284748780-12cef2736-7521-d83d-e063-dadaa90ab31fa9b114da-e742-5c34-e053-2a95a90ad6ae

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42509-034-01Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42509-034HAND SANITIZER (ETHYL ALCOHOL) GEL [WESSCO INTERNATIONAL]1Legacy NDC, 1 package rows20200706_a9b114da-e742-5c34-e053-2a95a90ad6ae.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42509-03442509-034-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
MALTODEXTRIN7CVR7L4A2DIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT

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
a99de9b7-49ab-9509-e053-2995a90ada9ca9b114da-e742-5c34-e053-2a95a90ad6ae2020-07-04WarningsExact identifier
spl id: a99de9b7-49ab-9509-e053-2995a90ada9c
spl set id: a9b114da-e742-5c34-e053-2a95a90ad6ae

Reported adverse events (FAERS/openFDA)#

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