Povidone Iodine
FDA Label NDC 49738-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kmart Corporation for the product Povidone Iodine (NDC 49738-050). 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 USP, 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, nonoxynol-8, purified water, sodium hydroxide

Otc - Questions


Label Information

Compare to active ingredient of Betadine® Solution*

NDC 49738-050-34

AMERICAN FARE

POVIDONE-
IODINE
SOLUTION

  • First Aid Antiseptic
  • Kills germs in minor burns, cuts and scrapes
    • 8 fl. oz. (236 mL)


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

    If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886.

    Distributed by:
    Kmart Corporation
    Hoffman Estates, IL 60179
    Made in USA

    Label (Pl 8229l A0806 2)

    Label (Pl 8229l A0806 2)



* Please review the disclaimer below.