Active Ingredient
Povidone Iodine 10% w/w (equivalent to iodine 1%)
Povidone-iodine Prep Pad
FDA Label NDC 70897-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Davemed Healthcare Co., Ltd for the product Povidone-iodine Prep Pad (NDC 70897-006). 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 active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Antiseptic for preparation of the skin.
Non-sterile Solution
Applicator is sterile if package is intact
Warnings
For external use only.
Discontinue use if irritation and redness develop.
Otc - Keep Out Of Reach Of Children
Keep out of reach of Children.
Directions
Apply locally as needed.
Inactive Ingredients
Purified Water
* Please review the disclaimer below.
