Otc - Active Ingredient
Active ingredient
Povidone Iodine 10%
Biotronix Healthcare
FDA Label NDC 71389-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biotronix Healthcare Industries, Inc. for the product Biotronix Healthcare (NDC 71389-101). 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, warnings, otc - stop use, dosage & administration, inactive ingredient, indications & usage, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Warnings
Warnings
For external use only. Do not use in the eyes.
Otc - Stop Use
Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling
Dosage & Administration
Direction
- Wet hands and forearms with water
- Clean under nails with nail cleaner
- Scrub for 3 minutes with the impregnated brush
- Pay close attention to the nails, cuticles, and interdigital spaces
- Rinse thoroughly with running water
- Repeat
Inactive Ingredient
Inactive ingredients
Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water
Indications & Usage
Uses For cleansing hands and arms prior to surgery
Other Safety Information
Other information
- Store at room temperature
- Avoid excessive heat above 40 °C (104 °F)
- Protect from freezing
- Latex free
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
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