FDA Label for Povidone Iodine Prep
View Indications, Usage & Precautions
Povidone Iodine Prep 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% w/v
Purpose
Antiseptic
Uses
- Antiseptic cleanser to help prevent skin 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 more than 1 week
- Over large areas of the body
Ask A Doctor Before Use If You Have
- Deep or puncture wounds
- Animal bites
- Serious wounds
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 immediately.
Directions:
- Tear at notch
- Use only once
- Clean affected area
- apply 1 to 3 times daily
- May be covered with a sterile bandage
- If bandaged, let dry first.
- Clean affected area
- Apply to operative site prior to surgery using applicator
As a first aid antiseptic
For preoperative patient skin preparation
Other Information
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients:
- Nonoxynol-9, water
Principal Display Panel
PVP Prep Solution
First Aid Antiseptic
NET WT. 0.75 oz
500 Packets per Case
Made in Israel
NDC 68786-132-01
* Please review the disclaimer below.