MEDICHOICE PVP- povidone-iodine swab

MediChoice PVP by

Drug Labeling and Warnings

MediChoice PVP by is a Otc medication manufactured, distributed, or labeled by Owens & Minor Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone Iodine USP,10% w/w

Purpose

Antiseptic

Use

For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

Do not use 

• in the eyes 
• on individuals who are allergic or sensitive to iodine 
• over large areas of the body 
• as a first aid antiseptic longer than one week unless directed by a doctor.

Consult a doctor

• in case of deep or puncture wounds, animal bites, or serious burns.

Stop use and consult a doctor

• if irritation or redness develops 
• if the condition persists or gets worse 
• infection occurs.

Keep out of reach of children.

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

Directions

For preparation prior to surgery
Clean the treatment area
Remove swab by stick
Apply to the operative site prior to surgery. For use as a first aid antiseptic
Clean the treatment area
Apply a small amount on the treatment area 1-3 times daily
May be covered with a sterile bandage
Let dry before covering.

Other information

• Store at room temperature.
• Avoid excessive heat.

Inactive ingredient

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxyno-10, Glycerine, Sodium Hydroxide, Potassium Iodide, Purified Water

Packgae Labeling:

MediChoice PVP Swabsticks, 500 Count (

39892-0812-2)

Package Labeling:

INGREDIENTS AND APPEARANCE

MEDICHOICE PVP 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0812
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0812-3	10 in 1 CASE	08/29/2017
1		25 in 1 BOX
1		3 in 1 PACKET
1		2.5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 39892-0812-2	500 in 1 CASE	08/29/2017
2		6 g in 1 POUCH; 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	08/29/2017

Labeler - Owens & Minor Inc. (847412269)

Registrant - Owens & Minor Inc. (847412269)