MEDICHOICE PVP SWABSTICKS- povidone-iodine swab

MediChoice PVP Swabsticks by

Drug Labeling and Warnings

MediChoice PVP Swabsticks by is a Otc medication manufactured, distributed, or labeled by Owens and Minor, Owens & Minor, Inc, Lights Medical Manufacture Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone Iodine 10% (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

• Healthcare topical antiseptic for preparation of the skin prior to surgery
• 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.

Stop use and ask a doctor

• if irritation and redness develop
• if condition persists or gets worse
• infection occurs

Consult a doctor in case of

• deep or puncture wounds
• animal bites
• serious burns.

Keep out of reach of children.

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

Directions

For preparation of the skin prior to surgery

• Clean the treatment area
• Remove swab by the 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 ingredients

Citric Acid, Purified water, Sodium phosphate dibasic

MediChoice PVP Swabsticks (3's) (

39892-0804-1)

INGREDIENTS AND APPEARANCE

MEDICHOICE PVP SWABSTICKS  
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0804
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 ACETATE (UNII: DSO12WL7AU)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0804-1	6 g in 1 PACKET; Type 0: Not a Combination Product	05/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/02/2013

Labeler - Owens and Minor (847412269)

Registrant - Owens & Minor, Inc (847412269)

Establishment
Name	Address	ID/FEI	Business Operations
Lights Medical Manufacture Co., Ltd.		529128649	manufacture(39892-0804)