POVIDINE IODINE - povidine iodine solution 
Chain Drug Consortium, LLC

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.

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Povidone Iodine Prep

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Uses: povidone iodine prep


             povidone iodine prep

Warnings:

Do not use:


Ask a doctor before use if you have:


Stop Use:


Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.


Directions:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic


For preoperative patient skin preparation


Inactive Ingredient:

Inactive Ingredient: Citric Acid, Glycerin, Sodium Citrate, Tween 80, Disodium Phosphate, Water

For use as an

Principal Display Panel

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povidone_iodine_prep


POVIDINE IODINE 
povidine iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-013-946 in 1 CASE
1236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/17/2011
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 5/2011
Document Id: 2089e3cb-5fe8-4aec-a5c9-3d0aea4ec941
Set id: 60e35882-6f9f-489d-8a49-8d61ce0db7bf
Version: 4
Effective Time: 20110524
 
Chain Drug Consortium, LLC