FDA Label for Povidone-iodine Pad Sterile
View Indications, Usage & Precautions
Povidone-iodine Pad Sterile Product Label
The following document was submitted to the FDA by the labeler of this product Jinhua Jingdi Medical Supplies Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Povidone-lodine 10%w/w
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
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