POVIDONE IODINE- povidine iodine solution 
Dynarex Corporation

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                          

Purpose

Purpose of povidone iodine prep

First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
For preparation of the skin prior to surgery.
Helps reduce bacteria that can potentially cause skin infections.

Inactive Ingredient

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

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:


As a first aid antiseptic


For preoperative patient skin preparation


For use as an

Principal Display Panel

povidone_iodine_prep

povidone_iodine_prep

POVIDONE IODINE 
povidine iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 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:67777-100-0648 in 1 CASE
159 mL in 1 BOTTLE
2NDC:67777-100-0148 in 1 CASE
2118 mL in 1 BOTTLE
3NDC:67777-100-0224 in 1 CASE
3237 mL in 1 BOTTLE
4NDC:67777-100-0324 in 1 CASE
4474 mL in 1 BOTTLE
5NDC:67777-100-0412 in 1 CASE
5946 mL in 1 BOTTLE
6NDC:67777-100-054 in 1 CASE
63784 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/03/2002
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Degasa, S.A. de C.V.812771980manufacture(67777-100)

Revised: 1/2015
Document Id: 3cbe99e8-56c9-47eb-a086-3e954b3fe398
Set id: 691044eb-28bd-4bf7-9a64-a8c33db2f7b3
Version: 6
Effective Time: 20150106
 
Dynarex Corporation