Povidone Iodine Prep Solution
FDA Label NDC 68786-132

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Povidone Iodine Prep (NDC 68786-132). 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 active ingredient, purpose, uses, warnings:, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

      • As a first aid antiseptic

      • Clean affected area
      • apply 1 to 3 times daily
      • May be covered with a sterile bandage
      • If bandaged, let dry first.

        • For preoperative patient skin preparation

        • Clean affected area
        • Apply to operative site prior to surgery using applicator



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



Untitled.jpg (Untitled)

Untitled.jpg (Untitled)



* Please review the disclaimer below.