POVIDONE IODINE- povidine iodine solution

povidone iodine by

Drug Labeling and Warnings

povidone iodine by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Degasa, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Purpose

Purpose of povidone iodine prep

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.

Inactive Ingredient

Inactive Ingredient: Citric Acid, Glycerin, Sodium Citrate, Tween 80, Disodium Phosphate, Water

Warnings:

• 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:

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
  

INDICATIONS & USAGE

For use as an

• first aid antiseptic
  
• pre-operative skin preperation
  

Principal Display Panel

povidone_iodine_prep

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidine iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-100
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-100-06	48 in 1 CASE
1		59 mL in 1 BOTTLE
2	NDC: 67777-100-01	48 in 1 CASE
2		118 mL in 1 BOTTLE
3	NDC: 67777-100-02	24 in 1 CASE
3		237 mL in 1 BOTTLE
4	NDC: 67777-100-03	24 in 1 CASE
4		474 mL in 1 BOTTLE
5	NDC: 67777-100-04	12 in 1 CASE
5		946 mL in 1 BOTTLE
6	NDC: 67777-100-05	4 in 1 CASE
6		3784 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/03/2002

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Degasa, S.A. de C.V.		812771980	manufacture(67777-100)