POVIDONE IODINE - povidone-iodine solution 
Triad Group

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DRUG FACTS

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



Ask a doctor in case of

  • deep or puncture wounds
  • animal bites
  • serious burns



Keep out of reach of children

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

DIRECTIONS


OTHER INFORMATION

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

INACTIVE INGREDIENTS

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


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


POVIDONE IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
sodium hydroxide (UNII: 55X04QC32I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50730-8230-1236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/06/2007
Labeler - Triad Group (050259597)

Revised: 2/2010
Document Id: bce84330-48e5-4544-b2a4-d547dc85ffe6
Set id: f35a7d34-0c33-4914-928e-2427949437b0
Version: 1
Effective Time: 20100222
 
Triad Group