POVIDONE IODINE PREP- povidone-iodine patch

Povidone Iodine Prep by

Drug Labeling and Warnings

Povidone Iodine Prep by is a Otc medication manufactured, distributed, or labeled by MCL Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Povidone-Iodine 10% (w/w) (equivalent to 1 % titratable iodine)

Purpose

Antiseptic

Use:

• For preparation of the skin prior to surgery 
• First aid antiseptic to help prevent infection in scrapes, minor cuts and burns

Warnings:

• For external use only

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Do not use:

• in the eyes or apply over large areas of the body 
• longer than 1 week unless directed by a doctor 
• on individuals who are sensitive or allergic to iodine

Stop use and ask a doctor if:

• if irritation and redness develop. 
• condition persists more than 72 hours
• in case of deep or puncture wounds, animal bites or serious burns

Directions:

• Clean the treatment area
• Apply a small amout of this product on the area 1~3 times daily 
• may be covered with a sterile bandage
• if bandaged, let dry first

Inactive Ingredient:

Purified Water

Package Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP 
povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71622-003
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71622-003-00	1 in 1 POUCH	07/25/2017
1		0.45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/25/2017

Labeler - MCL Enterprises (784754173)