MEDICHOICE PVP PREP SOLUTION- povidone-iodine solution

MediChoice PVP Prep Solution by

Drug Labeling and Warnings

MediChoice PVP Prep Solution by is a Otc medication manufactured, distributed, or labeled by O&M HALYARD, INC., Owens & Minor, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-Iodine, USP 10% (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

• Healthcare antiseptic for preparation of the skin prior to surgery.
• First aid antiseptic to help prevent 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 first aid antiseptic longer than 1 week unless directed by doctor.

Stop use and consult a doctor if

• you have deep or puncture wounds
• animal bites
• serious burns 
• the condition persists or gets worse
• irritation and redness develop

Keep out of reach of children.

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

Directions

• Clean the affected area
• for preparation of the skin prior to surgery, apply product to the operative site
• for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other information

Store at room temperature 59º-86ºF (15º-30ºC)

Inactive ingredients

citric acid monohydrate, sodium phosphate dibasic dihydrate, water

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

MEDICHOICE PVP PREP SOLUTION 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0841
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)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0841-1	118 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/25/2024
2	NDC: 39892-0841-2	48 in 1 CASE	01/25/2024
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/25/2024

Labeler - O&M HALYARD, INC. (081057389)

Registrant - Owens & Minor, Inc (847412269)