Otc - Active Ingredient
Active Ingredient: Povidone-Iodine 10% USP (equivalent to iodine 1%)
The following Structured Product Label (SPL) was submitted to the FDA by Yiwu Ori-power Medtech Co.,ltd. for the product Op-first Aid Series Povidone Iodine Prep Pad (NDC 72459-018). 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 - keep out of reach of children, otc - ask doctor, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient: Povidone-Iodine 10% USP (equivalent to iodine 1%)
Purpose: Antiseptic
Use
Warnings:
Keep out of reach of children
If swallowed get medical help or contact a poison control center right away.
Stop use
In case of deep or puncture wounds or serious burns and if pain, irritation, redness, swelling, or infection occurs, discontinue use and contact a physician.
Directions
Clean intended area thoroughly with pad, discard after single use.
Other information​
Store at room temperature 15°C-30°C (59°F-86°F)
Inactive Ingredients
Citric acid, disodiumphosphate, purified water.
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