FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
L3VEL3 LLC
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:43

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure8 sections

Dosage and administration

Pour enough product in your palm to cover hands and rub your hands together quickly until dry.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Hand Sanitizer

DESCRIPTION:

INDICATIONS & USAGE SECTION

LEVEL3 Hand Sanitizer provides powerful protection against germs, bacteria, and infections. Specially formulated for maximum protection, the non-sticky formula dries up quickly, leaving your hands feeling refreshed and sanitized.

Directions

DOSAGE & ADMINISTRATION SECTION

Pour enough product in your palm to cover hands and rub your hands together quickly until dry.

Warnings

WARNINGS SECTION

For external use only. Keep away from fire or flame, it is flammable. Keep out of the reach of children. Get medical attention if swallowed. Do not leave it under sunlight and higher than 104ºF (40ºC ). Avoid contact with the eyes. In case of contact with eyes, rinse with plenty of water.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. Get medical attention if swallowed.

Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat, Isopropyl Alcohol.

Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Polysorbate 20, Carbomer, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aqua 50ml LabelAqua 50ml Label

Aqua 50 mL Label NDC: 80848-001-01

Aqua 250 ml LabelAqua 250 ml LabelAqua 250 mL Label NDC: 80848-001-02

Ice 50ml LabelIce 50ml Label

Ice 50 mL Label NDC: 80848-001-03

Ice 250ml LabelIce 250ml Label

Ice 250 mL Label NDC: 80848-001-04

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80848-001-012022-01-28C16284748780-1d6a99b39-e931-a426-e053-dadaa90af4c2Hand Sanitizer
80848-001-022022-01-28C16284748780-1d6a99b39-e931-a426-e053-dadaa90af4c2Hand Sanitizer
80848-001-032022-01-28C16284748780-1d6a99b39-e931-a426-e053-dadaa90af4c2Hand Sanitizer
80848-001-042022-01-28C16284748780-1d6a99b39-e931-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80848-001-01Hand Sanitizer50 mL in 1 BOTTLE, PLASTICGEL501
80848-001-02Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
80848-001-03Hand Sanitizer50 mL in 1 BOTTLE, PLASTICGEL501
80848-001-04Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80848-001HAND SANITIZER (ALCOHOL) GEL [L3VEL3 LLC]1Legacy NDC, 4 package rows20201016_b1308a18-5c35-8510-e053-2a95a90ad565.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80848-00180848-001-01, 80848-001-02, 80848-001-03, 80848-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
b130697a-81eb-4d48-e053-2a95a90aae79b1308a18-5c35-8510-e053-2a95a90ad5652020-10-08WarningsExact identifier
spl id: b130697a-81eb-4d48-e053-2a95a90aae79
spl set id: b1308a18-5c35-8510-e053-2a95a90ad565

Reported adverse events (FAERS/openFDA)#

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