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 Ingredients

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

Purpose

Antiseptic

Use

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
• 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

• 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.

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 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 Ingredient

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

Principal Display Panel - Prep Solution 2 FL OZ Bottle Label

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 4 FL OZ Bottle Label

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 8 FL OZ Bottle Label

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 16 FL OZ Bottle Label

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

INGREDIENTS AND APPEARANCE

PREP SOLUTION 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-0023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	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: 65517-0023-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/26/2020
2	NDC: 65517-0023-2	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/26/2020
3	NDC: 65517-0023-3	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	05/18/2020
4	NDC: 65517-0023-4	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	10/23/2020

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)