FDA.reportPublic FDA data

Luxury Hand Sanitizer

Manufacturer
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:49

Label at a glance#

ProductLuxury Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

to helps reduce bacteria on the skin. For use when soap and water are not available

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to helps reduce bacteria on the skin.
  • For use when soap and water are not available

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Safety Instructions

OTHER SAFETY INFORMATION

Flammable, Keep away from fire and flame

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop Use and Ask a doctor if irritation or redness develops

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion , get medical help or contact Poison Control Center immediately.

Other Information

OTHER SAFETY INFORMATION

Store below 110°F (43°C)
May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbomer, aminomethyl propanol, fragrance, Aloe, Tocopheryl Acetate. Please review Label for further details

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

b1b1b2b2b3b3b4b4

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
76772-020-062023-01-30C16284748780-1f386c649-af94-0266-e053-dadaa90a7c1aLuxury Hygiene Hand Sanitizer: Advanced Regular
76772-020-102023-01-30C16284748780-1f386c649-af94-0266-e053-dadaa90a7c1aLuxury Hygiene Hand Sanitizer: Advanced Regular
76772-020-232023-01-30C16284748780-1f386c649-af94-0266-e053-dadaa90a7c1aLuxury Hygiene Hand Sanitizer: Advanced Regular
76772-020-472023-01-30C16284748780-1f386c649-af94-0266-e053-dadaa90a7c1aLuxury Hygiene Hand Sanitizer: Advanced Regular

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-020-06Luxury Hand Sanitizer60 mL in 1 BOTTLEGEL601
76772-020-10Luxury Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
76772-020-23Luxury Hand Sanitizer236 mL in 1 BOTTLEGEL2361
76772-020-47Luxury Hand Sanitizer472 mL in 1 BOTTLEGEL4721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-020LUXURY HAND SANITIZER (ETHYL ALCOHOL) GEL [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]1Legacy NDC, 4 package rows20201002_b0a28356-ba66-5959-e053-2995a90a86e6.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76772-02076772-020-47, 76772-020-06, 76772-020-10, 76772-020-23

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
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
b0a28520-5e64-4cc6-e053-2a95a90ab08bb0a28356-ba66-5959-e053-2995a90a86e62020-10-01WarningsExact identifier
spl id: b0a28520-5e64-4cc6-e053-2a95a90ab08b
spl set id: b0a28356-ba66-5959-e053-2995a90a86e6

Reported adverse events (FAERS/openFDA)#

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