FDA.reportPublic FDA data

Hand Sanitzer

Manufacturer
Luxe Decor Sales Ltd | GUANGDONG INTENTLY BIOTECHNOLOGY CO., LTD.
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:50

Label at a glance#

ProductHand Sanitzer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

highly effective alcohol-based hand sanitizing gel which sanitizes the skin without the need for water.

Dosage and administration

Directions ■ adults and children 2 years and older: apply to hands and rub for at least 30 seconds till dry

Storage and handling

Store below 40°C (100°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 74% v/v

Purpose

OTC - PURPOSE SECTION

Ethyl Alcohol 74% v/v................Antiseptic

Uses

INDICATIONS & USAGE SECTION

highly effective alcohol-based hand sanitizing gel which sanitizes the skin without the need for water.

Warnings

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from children. If swallowed, call a Poison Control Centre or a doctor. Supervise children using this product.

WARNINGS SECTION

Flammable. Keep away from flame and heat.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation develops

WARNINGS SECTION

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions ■ adults and children 2 years and older: apply to hands and rub for at least 30 seconds till dry

Other Information

STORAGE AND HANDLING SECTION

Store below 40°C (100°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbomer, triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287762ethanol 74 % Topical GelPSN2
2287762ethanol 0.74 ML/ML Topical GelSCD2
2287762ethanol 74 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80511-001-012022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396
80511-001-022022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396
80511-001-032022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396
80511-001-042022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396
80511-001-052022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396
80511-001-062022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396
80511-001-072022-07-29C16284748780-1e4f33bdf-a694-d8a0-e053-dadaa90a6e4eae7f2bac-bf1e-cf54-e053-2a95a90a7396

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80511-001-01Hand Sanitzer50 mL in 1 BOTTLEGEL502
80511-001-02Hand Sanitzer50 mL in 1 BOTTLEGEL502
80511-001-03Hand Sanitzer80 mL in 1 BOTTLEGEL802
80511-001-04Hand Sanitzer236 mL in 1 BOTTLEGEL2362
80511-001-05Hand Sanitzer500 mL in 1 BOTTLEGEL5002
80511-001-06Hand Sanitzer1000 mL in 1 BOTTLEGEL10002
80511-001-07Hand Sanitzer3780 mL in 1 BOTTLEGEL37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80511-001HAND SANITZER (ETHYL ALCOHOL) GEL [LUXE DECOR SALES LTD]2Legacy NDC, 7 package rows20210113_ae7f2bac-bf1e-cf54-e053-2a95a90a7396.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
80511-00180511-001-01, 80511-001-03, 80511-001-04, 80511-001-02, 80511-001-05, 80511-001-06, 80511-001-07

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

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
b8b965a7-d88a-c03b-e053-2995a90aa128ae7f2bac-bf1e-cf54-e053-2a95a90a73962021-01-12WarningsExact identifier
spl id: b8b965a7-d88a-c03b-e053-2995a90aa128
spl set id: ae7f2bac-bf1e-cf54-e053-2a95a90a7396

Reported adverse events (FAERS/openFDA)#

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