POVIDONE IODINE solution

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, Ltd., Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

A microbicidal cleanser

• For the Veterinarian: Preoperative and postoperative scrubbing and washing.
• For the Animal: Preoperative prepping.

DRUG FACTS

• ACTIVE INGREDIENT: PURPOSE
• Povidone Iodine, 7.5%: Antiseptic

USES

• For preparation of the skin prior to surgery.
• Helps to reduce bacteria that potentially can cause skin infection.
• For hand washing to reduce bacteria on the skin.
• Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

DIRECTIONS

Surgical hand scrub:

• Wet hands with water.
• Spread about 5 cc (1 teaspoonful) of scrub over both hands and forearms.
• Without adding more water, scrub thoroughly for 2½-3 minutes.
• Use a sponge, if desired. Clean thoroughly under fingernails.
• Add a little water and develop copious suds.
• Rinse thoroughly under running water.
• Repeat entire procedure using another 5 cc of scrub.

Antiseptic hand wash:

• Wet hands with water and pour about 5 cc of scrub on hands.
• Rub hands vigorously together for at least 15 seconds, covering all surfaces.
• Rinse and dry with a disposable towel.

Preoperative skin preparation:

• After the surgical area is clipped, wet it with water.
• Apply scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather, and scrub thoroughly for about 5 minutes.
• Rinse using sterile gauze saturated with water.
• The area may then be painted with Betadine solution and alllowed to dry.

WARNINGS

For external use only. Do not use this product in the eyes or on food-producing animals.

When using this product, prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions. In preoperative prepping, avoid "pooling" beneath the animal.

Stop use and ask a doctor or veterinarian if irritation and redness develops or in rare instances of local irritation or sensitivity.

STORAGE AND HANDLING

Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F).  Do Not Freeze. Store in original container.

KEEP OUT OF REACH OF CHILDREN

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

SPL UNCLASSIFIED SECTION

REORDER NO: AHI59014

IN 50-1235

Manufactured in the USA

Manufactured for:

Aspen Veterinary Resources,® Ltd.

Liberty, MO 64068, USA

www.aspenveterinaryresources.com

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

NDC: 46066-064-01

Aspen Veterinary Resources,® Ltd.

Povidine Iodine Scrub

Antiseptic Sudsing Skin Cleanser

For Professional and

Hospital Veterinary Use Only

For External Use Only

For Animal Use Only

Keep Out of Reach of Children

NET CONTENTS: 1 Gallon (3.79 L)

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.75 g  in 100 mL

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-064-01	3790 mL in 1 BOTTLE
2	NDC: 46066-064-00	946 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/22/2015	04/30/2020

Labeler - Aspen Veterinary Resources, Ltd. (627265361)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Pharmaceutical, Inc.		832848639	manufacture