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.

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Povidone Iodine Swabstick

Section Text

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Purpose:


Purpose:

Warnings:

Section Text

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:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic


For preoperative patient skin preparation


Other information:

Store at room temperature.

Avoid excessive heat

For use as an

Inactive Ingredients

Inactive ingredients: nonoxynol-9, water

Principal Display Panel

Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

Povidone iodine.jpg

Povidone iodine

POVIDINE IODINE 
povidine iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-130
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
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-130-0150 in 1 BOX
10.3 mL in 1 PACKET
2NDC:67777-130-0225 in 1 BOX
20.9 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/10/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(67777-130)

Revised: 12/2013
Document Id: 6e0bb046-ea9e-471b-82aa-815a291dbaef
Set id: 40e18738-4357-48e2-8b07-789cf16af640
Version: 8
Effective Time: 20131218
 
Dynarex Corporation