Povidine Iodine
FDA Label NDC 67777-420

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 Povidine Iodine (NDC 67777-420). 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, do not use:, warnings, ask a doctor before use if you have:, stop use:, keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Section Text

Active Ingredient                                                      Purpose

Povidone Iodine 10% w/v (9.85% w/w)                       Antiseptic                          

Purpose

  • 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.

Do Not Use:

Section Text


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

Warnings

FOR EXTERNAL USE ONLY

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:

Tear at notch, remove applicator, 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.

    • For preoperative patient skin preparation

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


Usage

  • As a first aid antiseptic and preparation of skin prior to surgery.

Other Information:

Store at room temperature.

Avoid excessive heat

Inactive Ingredients

Citric acid, glycerin, poysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

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