Otc - Active Ingredient
Alcohol 70% v/w
Biolustre Hygienic Hand Cleansing Gel
FDA Label NDC 80371-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Koyuncu Bilisim Teknolojileri Sanayi Ve Ticaret Limited Sirketi for the product Biolustre Hygienic Hand Cleansing Gel (NDC 80371-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
Used for antibacterial hand skin, prevent bacteria.
Warnings
For external use only. Flammable. Keep away from fire.
Otc - Do Not Use
• Keep away from fire.
• Do not wipe your eyes.
• Do not throw into the toilet (not soluble in water).
Otc - When Using
• 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
Stop use and ask a doctor for those with alcohol allergy or sensitive skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
• Store between 15-30°C (59-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredient
Water, Glycerin, Carbomer, Triethanolamine
Dosage & Administration
Use it as needed, after following the usage instructions. For external use only.
* Please review the disclaimer below.
