PVP-I PREP PADS FOIL-FOIL- povidone-iodine swab

PVP-I Prep Pads foil-foil by

Drug Labeling and Warnings

PVP-I Prep Pads foil-foil by is a Otc medication manufactured, distributed, or labeled by Dukal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Povidone Iodine USP 10%

Purpose:

Antiseptic

Use:

For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.

Warnings:

For external use only.

DO NOT USE

Do not apply to persons allergic to iodine. Do not use in the eyes.

• Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

• Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
• Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

• Keep out of reach of children
• If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions:

Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.

Other Information:

1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.

Inactive Ingredients:

Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.

Principal Display Panel - PVP-I Prep Pads Foil Pouch Label

DUKAL™
CORPORATION

REF 882

STERILE

Povidone-Iodine
Prep Pad

For Professional and Hospital Use

Not Made with Natural Rubber Latex

1
/Pouch

Manufactured For:

DUKAL CORPORATION (631) 656-3800

Ronkonkoma, NY 11779 www.dukal.com

Made in China

2

Principal Display Panel - PVP-I Prep Pads Foil 865-8000 Case Label

DUKAL™
CORPORATION

REF 882-8000

STERILE

POVIDONE-IODINE
PREP PADS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

8000/Case

1/Pack

2

Manufactured For: DUKAL CORPORATION (631) 656-3800

Ronkonkoma, NY 11779 www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973025023

INGREDIENTS AND APPEARANCE

PVP-I PREP PADS FOIL-FOIL 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-0034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65517-0034-1	8000 in 1 CASE	01/31/2018
1		0.5 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/31/2018

Labeler - Dukal Corporation (791014871)