POVIDONE IODINE solution

povidone iodine by

Drug Labeling and Warnings

povidone iodine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Uses

• First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
• Healthcare antiseptic for preparation of the skin prior to surgery.
• Antiseptic cleanser for preparation of skin prior to an infection.

Warnings

• FOR EXTERNAL USE ONLY

Do not use

• As a first aid antiseptic for more than 1 week unless directed by a doctor.
• In the eyes.
• Over large areas of the body.
• On individuals who are allergic  or sensitive to iodine.

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 a small amount of this product to the area1 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

Inactive Ingredient

• citric acid
• glycerin
• sodium citrate
• tween 80
• disodium phosphate
• purified Water

INDICATIONS & USAGE

For use as an

• first aid antiseptic
  
• pre-operative skin preperation
  

Principal Display Panel

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-1103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 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: 0904-1103-09	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/21/2011

Labeler - Major Pharmaceuticals (191427277)