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  5. Label Information: Povidone Iodine

FDA Label for Povidone Iodine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT
    6. DISCONTINUE USE AND ASK A DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. ASK A DOCTOR IN CASE OF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. OTC - QUESTIONS
    17. PACKAGE INFORMATION

Povidone Iodine Product Label

The following document was submitted to the FDA by the labeler of this product Triad Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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





Package Information



MEDIC®

NDC 50730-8230-1

*COMPARE TO THE ACTIVE
INGREDIENT IN BETADINE®

10% Topical Solution
Povidone
Iodine

For External Use Only

Helps prevent the risk of
infection in minor cuts,
scrapes and burns


8 FL OZ (236 mL)

Distributed by Winn-Dixie Stores, Inc.
Jacksonville, FL 32254
©2008 Winn-Dixie Stores, Inc.

Quality Guaranteed
1-866-WINN-DIXIE
www.winn-dixie.com

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

label - PL 8230L A0108

label - PL 8230L A0108




* Please review the disclaimer below.