FDA.reportPublic FDA data

Full Clean Hand Sanitizer Gel

Manufacturer
Luxe Tech LLC
Effective date
2021-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:10

Label at a glance#

ProductFull Clean Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that can potentially cause disease.

Warnings

WARNINGS SECTION

For external use only.
Flammable. Keep away from fire or flame.

Do not inhale or ingest.

Do not use

OTC - DO NOT USE SECTION

near or in the eyes.

  • In case of contact, flush eyes with water. Avoid contact with broken skin.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • Irritation or redness develops. 
  • Condition persists for more than 72 hours.

Keep out of the 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

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.

Other Information:

SPL UNCLASSIFIED SECTION

  • Store below 110ºf (43ºc). 
  • May discolor certain fabrics or surfaces.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Hydroxyethyl Cellulose (gelling agent), Triethanolamine (for pH balance).

Package Labeling:81167-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:81167-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.2Label.2

Package Labeling:81167-001-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling:81167-001-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.4Label.4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81167-001-012023-01-30C16284748780-1f386c64a-313d-0266-e053-dadaa90a7c1aFull Clean Hand Sanitizer Gel
81167-001-022023-01-30C16284748780-1f386c64a-313d-0266-e053-dadaa90a7c1aFull Clean Hand Sanitizer Gel
81167-001-032023-01-30C16284748780-1f386c64a-313d-0266-e053-dadaa90a7c1aFull Clean Hand Sanitizer Gel
81167-001-042023-01-30C16284748780-1f386c64a-313d-0266-e053-dadaa90a7c1aFull Clean Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81167-001-01Full Clean Hand Sanitizer200 mL in 1 BOTTLEGEL2002
81167-001-02Full Clean Hand Sanitizer4000 mL in 1 BOTTLEGEL40002
81167-001-03Full Clean Hand Sanitizer60 mL in 1 BOTTLEGEL602
81167-001-04Full Clean Hand Sanitizer1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81167-001FULL CLEAN HAND SANITIZER (ALCOHOL) GEL [LUXE TECH LLC]2Legacy NDC, 4 package rows20210304_b6c16eed-547a-7246-e053-2995a90a8522.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81167-00181167-001-01, 81167-001-02, 81167-001-03, 81167-001-04

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
ALOE VERA LEAFZY81Z83H0XIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
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
bca5f19f-afd4-3a3d-e053-2a95a90a1629b6c16eed-547a-7246-e053-2995a90a85222021-03-03WarningsExact identifier
spl id: bca5f19f-afd4-3a3d-e053-2a95a90a1629
spl set id: b6c16eed-547a-7246-e053-2995a90a8522

Reported adverse events (FAERS/openFDA)#

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