Otc - Active Ingredient
Povidone-Iodine USP 10%
Povidon Iodine Prep Pads
FDA Label NDC 49953-0725
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dalian Rongbang Medical Healthy Devices Co., Ltd. for the product Povidon Iodine Prep Pads (NDC 49953-0725). 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, use, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Use
Antiseptic Skin Preparation
Warnings
For External use only
Avoid excessive heat. Store at room temperature.
Otc - Do Not Use
Do not use if allergic to iodine
Otc - Stop Use
Stop use and ask a doctor if infection occurs or if redness, irriation, swelling or pain persists or increases
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidentla ingestion, seek professional assistance or consult a poision control center immediately
Directions
Apply locally as needed
Other Information
1% titratable iodine
For hospital or professional use only
Inactive Ingredient
Purified water
* Please review the disclaimer below.
