Povidone Iodine
FDA Label NDC 67777-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Povidone Iodine (NDC 67777-100). 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 otc - active ingredient, purpose, inactive ingredient, warnings:, do not use:, ask a doctor before use if you have:, stop use:, 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

Otc - Active Ingredient

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Purpose

Purpose of povidone iodine prep

First aid antiseptic 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 infections.

Inactive Ingredient

Inactive Ingredient: Citric Acid, Glycerin, Sodium Citrate, Tween 80, Disodium Phosphate, Water

Warnings:

  • FOR EXTERNAL USE ONLY

Do Not Use:


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Ask A Doctor Before Use If You Have:


  • Deep puncture wounds
  • Animal bites
  • Serious burns

Stop Use:


  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.


Directions:


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.

    • For preoperative patient skin preparation

    • clean area
    • apply to operative site prior to surgery using the applicator


Indications & Usage

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Principal Display Panel

povidone_iodine_prep

Povidone_iodine_prep (Povidone Iodine Prep)

Povidone_iodine_prep (Povidone Iodine Prep)

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