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Prep Solution

Dukal Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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


Active ingredient

Active Ingredient

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

Purpose

Antiseptic

Purpose

Uses

Healthcare antiseptic for preparation of 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.

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 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.

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

Uses

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.

Other information

Protect from freezing

Avoid excessive heat

Inactive Ingredients

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

PVP Prep Label

Prep Solution

Prep Solution

POVIDONE-IODINE SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65517-0009
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POVIDONE-IODINE IODINE 1.20 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65517-0009-1 59 in 1 BOTTLE
2 NDC:65517-0009-2 59 in 1 BOTTLE, SPRAY
3 NDC:65517-0009-3 118 in 1 BOTTLE
4 NDC:65517-0009-4 237 in 1 BOTTLE
5 NDC:65517-0009-5 473 in 1 BOTTLE
6 NDC:65517-0009-6 946 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part333 2010-01-01


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