Your browser does not support JavaScript! PREP SOLUTION (POVIDONE-IODINE) SOLUTION [DUKAL CORPORATION]
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PREP SOLUTION (povidone-iodine) solution
[Dukal Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

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

Purpose

Antiseptic

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.

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

PVP Prep 2 oz Label

PREP SOLUTION 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65517-0009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE and IODINE) POVIDONE-IODINE1.20 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-0009-159 mL in 1 BOTTLE
2NDC:65517-0009-259 mL in 1 BOTTLE, SPRAY
3NDC:65517-0009-3118 mL in 1 BOTTLE
4NDC:65517-0009-4237 mL in 1 BOTTLE
5NDC:65517-0009-5473 mL in 1 BOTTLE
6NDC:65517-0009-6946 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33301/01/2010
Labeler - Dukal Corporation (791014871)

Revised: 7/2010
 
Dukal Corporation

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