FDA Label for Povidone Iodine
View Indications, Usage & Precautions
Povidone Iodine Product Label
The following document was submitted to the FDA by the labeler of this product Sion Biotext Medical 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.
Active Ingredient
Povidone Iodine 10%
Purpose
Antiseptic
Uses
- Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns.
- For preparation of the skin prior to surgery.
- Helps reduce bacteria that can potentially cause skin infection.
Warnings
For External Use Only.
Do Not Use
- In the eyes
- As a first aid antiseptic for longer than 1 week
- Over large areas of the body
Ask A Doctor Before Use If You Have
- Deep or puncture wounds
- Animal bites
- Serious burns
Stop Use And Ask A Doctor If
- Condition worsens or persists for more than 72 hours
- Irritation and redness develops
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Tear at notch
- Remove applicator
- Use only once
- Clean affected area
- apply 1-3 times daily
- May be covered with a sterile bandage
- If bandaged, let dry first. For preoperative patient skin preparation
- Clean area
- Apply to operative site prior to surgery using applicator
As a first aid antispetic
Other Information
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients
Nonoxynol-9, water
Principal Display Panel
50
Packets
Povidone-Iodine
Swabsticks
Antispetic/Germicide
For External Use Only
Sion Biotext
Medical Ltd.
* Please review the disclaimer below.