Otc - Active Ingredient
Povidone-lodine 10%w/w
Povidone-iodine Pad Sterile Cloth
FDA Label NDC 83446-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jinhua Jingdi Medical Supplies Co., Ltd for the product Povidone-iodine Pad Sterile (NDC 83446-101). 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, description, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
Use for preparation of the skin prior to surgery.
Sterile in unopened, undamaged package.
Not made with natural rubber latex.
Inactive Ingredient
Sodium bicarbonate, polysorbate-80, polyethylene glycol, potassium iodide, purified water
Otc - Purpose
Antiseptic
For preparation of the skin prior to surgery
Warnings
For external use only.
Do not apply to persons allergic to iodine.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
Clean area. Apply to the operative site prior to surgery.
Otc - Do Not Use
Do not Use in the eyes.
Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Other Safety Information
1% titratable iodine.
Store at ambient temperature.
Dosage & Administration
Apply topically as needed to cleanse intendend areaï¼›
Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.
Package Label.Principal Display Panel
Pvp Pad (Pvp)
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