povidine iodine by Dynarex Corporation / Sion Biotext Medical Ltd POVIDINE IODINE swab

povidine iodine by

Drug Labeling and Warnings

povidine iodine by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

POVIDINE IODINE 
povidine iodine swab

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

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

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

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

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

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

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