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                          

Purpose:

Purpose:

• 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:

• 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 Povidone iodine:

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

INDICATIONS & USAGE

For use as an

• first aid antiseptic
  
• pre-operative skin preperation
  

Inactive Ingredients

Inactive ingredients: nonoxynol-9, water

Principal Display Panel

Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

Povidone iodine.jpg

INGREDIENTS AND APPEARANCE

POVIDINE IODINE 
povidine iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 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: 67777-130-01	50 in 1 BOX
1		0.3 mL in 1 PACKET
2	NDC: 67777-130-02	25 in 1 BOX
2		0.9 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/10/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(67777-130)