POVIDINE IODINE - povidine iodine swab 
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.

----------

Povidone Iodine Gel Swabstick

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Uses:




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 Povidone Iodine Gel Swabstick:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic


For preoperative patient skin preparation


Other information:

Sterile

Store at room temperature.

Avoid excessive heat

For use as an

Inactive Ingredients

Inactive ingredients: citric acid, glycerol, nonoxynol-10, sodium hydroxide, water

Principal Display Panel



PVP_Gel_Swabstick

PVP_Gel_Swabstick

POVIDINE IODINE 
povidine iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-301
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
NONOXYNOL-10 (UNII: K7O76887AP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-301-0110 in 1 CASE
150 in 1 BOX
11 in 1 POUCH
1.3 mL in 1 POUCH
2NDC:67777-301-0210 in 1 CASE
225 in 1 BOX
23 in 1 POUCH
2.9 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/10/2012
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 2/2012
Document Id: 99a0044c-71d6-4377-9834-8c573d088bf0
Set id: 9262e033-8f8c-4d41-88f1-19a4da30d9db
Version: 1
Effective Time: 20120210
 
Dynarex Corporation