Prep Solution

Manufacturer: Dukal Corporation
Effective date: 2018-09-13
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:50:46

Label at a glance#

ProductPrep Solution

Active ingredientPOVIDONE-IODINE

Label structure11 sections

Dosage and administration

Clean the affected area For preparation of the skin prior to surgery: apply 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.

Contacts and useful links#

PhoneLabel contact(631) 656-3800

Websitewww.dukal.com

www.dukal.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Healthcare antiseptic for preparation of the skin prior to surgery

First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only. Do not use

in the eyes
longer than 1 week unless directed by doctor
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body.

Stop use and ask doctor

OTC - STOP USE SECTION

if irritation and redness develop
if condition persists for 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area

For preparation of the skin prior to surgery: apply 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

OTHER SAFETY INFORMATION

Protect from freezing. Avoid excessive heat.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - Prep Solution 2 FL OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REORDER

871

NDC 65517-0023-1

Povidone Iodine USP, 10%

Topical Antiseptic Microbicide

PREP SOLUTION

Solución de preparación

Povidona yodada, 10%

Antiséptico antimicrobiano tópico

Solution de préparation

Polyvidone iodée, 10 %

Microbicide antiseptique topique

DUKAL

Q.V.P

Corporation

2 FL OZ (59ml)

DUKAL CORPORATION (631) 656-3800

Ronkonkoma, NY 11779 www.dukal.com

Made in Mexico, Hecho en México, Fabriqué en Mexique

D04201101

Principal Display Panel - Prep Solution 2 FL OZ Bottle Label

Principal Display Panel - Prep Solution 4 FL OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REORDER

872

NDC 65517-0023-2

Povidone Iodine USP, 10%

Topical Antiseptic Microbicide

PREP SOLUTION

Solución de preparación

Povidona yodada, 10%

Antiséptico antimicrobiano tópico

Solution de préparation

Polyvidone iodée, 10 %

Microbicide antiseptique topique

DUKAL

Q.V.P

Corporation

4 FL OZ (118ml)

DUKAL CORPORATION (631) 656-3800

Ronkonkoma, NY 11779 www.dukal.com

Made in Mexico, Hecho en México, Fabriqué en Mexique

D04201103

Principal Display Panel - Prep Solution 4 FL OZ Bottle Label

Principal Display Panel - Prep Solution 8 FL OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REORDER

873

NDC 65517-0023-3

Povidone Iodine USP, 10%

Topical Antiseptic Microbicide

PREP SOLUTION

Solución de preparación

Povidona yodada, 10%

Antiséptico antimicrobiano tópico

Solution de préparation

Polyvidone iodée, 10 %

Microbicide antiseptique topique

DUKAL

Q.V.P

Corporation

8 FL OZ (237ml)

DUKAL CORPORATION (631) 656-3800

Ronkonkoma, NY 11779 www.dukal.com

Made in Mexico, Hecho en México, Fabriqué en Mexique

D04201105

Principal Display Panel - Prep Solution 8 FL OZ Bottle Label

Principal Display Panel - Prep Solution 16 FL OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REORDER

874

NDC 65517-0023-4

Povidone Iodine USP, 10%

Topical Antiseptic Microbicide

PREP SOLUTION

Solución de preparación

Povidona yodada, 10%

Antiséptico antimicrobiano tópico

Solution de préparation

Polyvidone iodée, 10 %

Microbicide antiseptique topique

DUKAL

Q.V.P

Corporation

16 FL OZ (473ml)

DUKAL CORPORATION (631) 656-3800

Ronkonkoma, NY 11779 www.dukal.com

Made in Mexico, Hecho en México, Fabriqué en Mexique

D04201105

Principal Display Panel - Prep Solution 16 FL OZ Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Prep Solution
POVIDONE-IODINE
WATER
IODINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65517-0023	65517-0023-1, 65517-0023-2, 65517-0023-3, 65517-0023-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
POVIDONE-IODINE	85H0HZU99M	ACTIM

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
75c6deb6-70f0-771b-e053-2a91aa0ae17c			8373d862-fb3d-4679-ae1b-b5feca9f825a	2018-09-13	Warnings	Exact identifier spl id: 75c6deb6-70f0-771b-e053-2a91aa0ae17c spl set id: 8373d862-fb3d-4679-ae1b-b5feca9f825a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.