Povidine Iodine
FDA Label NDC 67777-140

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 67777-140). 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, uses:, warnings:, do not use:, 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% v/v                        Antiseptic                          

Uses:


Section Text

  • 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.

Warnings:

Section Text

  • FOR EXTERNAL USE ONLY

Do Not Use:

Section Text


  • 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:

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


Other Information:

Store at room temperature.

Avoid excessive heat

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Povidone_iodine (Povidone Iodine)

Povidone_iodine (Povidone Iodine)

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