Label: POVIDONE IODINE- povidone-iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50730-8230-1 - Packager: Triad Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 22, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DIRECTIONS
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
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PACKAGE INFORMATION
MEDIC®
NDC 50730-8230-1
*COMPARE TO THE ACTIVE
10% Topical Solution
INGREDIENT IN BETADINE®
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®.
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INGREDIENTS AND APPEARANCE
POVIDONE IODINE
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-8230 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine 0.10 mg in 1 mL Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) sodium hydroxide (UNII: 55X04QC32I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50730-8230-1 236 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/06/2007 Labeler - Triad Group (050259597)