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 Prep Pad

Section Text

Active Ingredient Purpose

Povidone Iodine 10% v/v Antiseptic

Uses:

Section Text

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.

Warnings:

Section Text

FOR EXTERNAL USE ONLY

Do not use:

Section Text

As a first aid antiseptic for more than 1 week.
In the eyes.
Over large areas of the body.

Ask a doctor before use if you have:

Deep puncture wounds
Animal bites
Serious burns

Stop Use:

If irritation and redness develop
If condition persists for more than 72 hours, consult a physician.

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

clean affected area
apply 1 to 3 times daily
may be covered with a sterile bandage, if bandaged let dry.

For preoperative patient skin preparation

clean area
apply to operative site prior to surgery using the applicator

Other information:

Store at room temperature.

Avoid excessive heat

Principal Display Panel

Principal Display Panel

Povidone_iodine

POVIDINE IODINE
povidine iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67777-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	10 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67777-140-01	10 in 1 CASE
1		100 in 1 BOX
1		.3 mL in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	05/10/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Name	Address	ID/FEI	Business Operations
Establishment
Sion Biotext Medical Ltd		532775194	manufacture

Revised: 5/2010

Document Id: 56609c63-de60-4111-a317-4f0fc1db502b

Set id: e39ef99d-c778-4862-9d93-4074753c47ad

Version: 1

Effective Time: 20100510

Dynarex Corporation