Povidone Iodine Swab
FDA Label NDC 68786-130

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 (NDC 68786-130). 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%

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

    • As a first aid antispetic

    • 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

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.

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