Otc - Active Ingredient
Alcohol 70% v/w
Biowipes Alcohol Wipes
FDA Label NDC 81088-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yemyesil Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Limited Sirketi for the product Biowipes Alcohol Wipes (NDC 81088-101). 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, Hand sanitizer wipes
Indications & Usage
- For hand sanitizing to decrease bacteria and germs on the skin.
- Apply topically to the skin to help prevent cross contamination.
- Dries in seconds
- Anticeptic wipe to help reduce bacteria and germs potentially can cause disease. For use when soap an water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame. Not recommended for repeated use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
- Children under 2 years of age.
- On open skin wounds.
Otc - When Using
When using this product - keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin - do not inhale or ingest this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops. If condition persists for more than 72 hours seek medical attention.
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
Dosage & Administration
Use it as needed, after following the usage instructions. For external use only.
* Please review the disclaimer below.
