Povidone Iodine Solution
FDA Label NDC 24385-053

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Povidone Iodine (NDC 24385-053). 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, use, warnings, do not, discontinue use and ask a doctor, otc - ask doctor/pharmacist, otc - when using, 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 (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

For external use only.


Do Not

  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Discontinue Use And Ask A Doctor

  • if condition persists or gets worse
  • for use longer than 1 week

Otc - Ask Doctor/Pharmacist


Otc - When Using


Ask A Doctor In Case Of

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Pregnancy Or Breast Feeding


Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area
  • Apply a small amount of this product to the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Other


Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients

Citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Otc - Questions


Label Information

NDC 24385-053-55

GOOD NEIGHBOR PHARMACY

povidone iodine, 10% solution

*Compare to active ingredient in BETADINE®

Topical antiseptic

Helps prevent infection in minor cuts, scrapes, and burns

  • Use for first aid and general hygiene
  • Helps reduce bacteria that can potentially cause skin infection
  • Water soluble

    • 8 fl. oz. (236 mL)

    Distributed By
    AmerisourceBergen
    Valley Forge, PA 19482-0959
    Visit us at www.myGNP.com

    *This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.



* Please review the disclaimer below.