FDA.reportPublic FDA data

Biolustre Disposable Hand Cleansing Gel

Manufacturer
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:27

Label at a glance#

ProductBiolustre Disposable Hand Cleansing Gel
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

• Store between 15-30°C (59-86°F). • Avoid freezing and excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/w

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Used for antibacterial hand skin, prevent bacteria

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• Keep away from fire.
• Do not wipe your eyes.
• Do not throw into the toilet (not soluble in water).

OTC - WHEN USING SECTION

• Please wait until the alcohol has completely evaporated after wiping.
• Before use, check whether the packaging is intact. Do not use if it is damaged.

OTC - STOP USE SECTION

Stop use and ask a doctor for those with alcohol allergy or sensitive skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

• Store between 15-30°C (59-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Triethanolamine

DOSAGE & ADMINISTRATION SECTION

Use it as needed, after following the usage instructions. For external use only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biolustre Disposable Hand Cleansing GelBiolustre Disposable Hand Cleansing Gel

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
80371-105-012023-01-30C16284748780-1f386c649-af97-0266-e053-dadaa90a7c1ab06a3464-7d47-8b31-e053-2995a90a9a02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80371-105-01Biolustre Disposable Hand Cleansing Gel3 mL in 1 POUCHGEL31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80371-105BIOLUSTRE DISPOSABLE HAND CLEANSING GEL (ETHYL ALCOHOL) GEL [KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 1 package rows20200929_b06a3464-7d47-8b31-e053-2995a90a9a02.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
80371-10580371-105-01

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
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT

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
b06a3464-7d48-8b31-e053-2995a90a9a02b06a3464-7d47-8b31-e053-2995a90a9a022020-09-28WarningsExact identifier
spl id: b06a3464-7d48-8b31-e053-2995a90a9a02
spl set id: b06a3464-7d47-8b31-e053-2995a90a9a02

Reported adverse events (FAERS/openFDA)#

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