PREP SOLUTION- povidone-iodine solution

Prep Solution by

Drug Labeling and Warnings

Prep Solution by is a Otc medication manufactured, distributed, or labeled by Dukal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Povidone-Iodine 10% (equivalent to 1% available iodine)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

Healthcare antiseptic for preparation of skin prior to surgery.

First Aid Antiseptic to help prevent infection in minor cuts scrapes and burns.

WARNINGS

Warnings

For external use only.

DO NOT USE

Do Not Use

In the eyes.

longer than 1 week unless directed by a doctor

on individuals who are allergic or sensitive to iodine

or apply over large area of the body

STOP USE

Stop use and ask a doctor

If irritation and redness develop

If condition persists more than 72 hours

In case of deep or puncture wounds, animal bites or serious burns, consult a doctor

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Clean the affected area

For preparation of skin prior to surgery:

apply the product to the operative site prior to surgery.

For first aid antiseptic:

apply a small amount of this product on the area 1 to 3 times daily.

May be covered with a sterile bandage.

If bandaged, let dry first.

STORAGE AND HANDLING

Other information

Protect from freezing

Avoid excessive heat

INACTIVE INGREDIENT

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Polysorbate 80, Sodium Citrate, Water

PRINCIPAL DISPLAY PANEL

MediChoice

Prep Solution

Topical Antiseptic

Povidone Iodine USP

10% Topical Solution

Distributed by Owens and Minor

Mechanicsville, VA 23116

(804) 723-7000

owens-minor.com

PVP Prep Label

INGREDIENTS AND APPEARANCE

PREP SOLUTION 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1.1 mg  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65517-0009-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	08/26/2020
2	NDC: 65517-0009-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2010	05/18/2012
3	NDC: 65517-0009-3	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/26/2020
4	NDC: 65517-0009-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/23/2020
5	NDC: 65517-0009-5	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/23/2020
6	NDC: 65517-0009-6	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2010	10/26/2020

Labeler - Dukal Corporation (791014871)