POVIDONE IODINE solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Available from:
Aspen Veterinary Resources, Ltd.
INN (International Name):
POVIDONE-IODINE
Composition:
IODINE 0.75 g in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC
Therapeutic indications:
A microbicidal cleanser - For the Veterinarian: Preoperative and postoperative scrubbing and washing. - For the Animal: Preoperative prepping. - 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.
Authorization status:
unapproved drug other
Authorization number:
46066-064-00, 46066-064-01

POVIDONE IODINE- povidone iodine solution

Aspen Veterinary Resources, Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Povidine Iodine Scrub

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

(0.75% available iodine)

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.

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.

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)

POVIDONE IODINE

povidone iodine solution

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:46 0 6 6 -0 6 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

0 .75 g in 10 0 mL

Product Characteristics

Color

bro wn

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 0 6 6 -0 6 4-0 1

379 0 mL in 1 BOTTLE

2

NDC:46 0 6 6 -0 6 4-0 0

9 46 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 6 /22/20 15

0 4/30 /20 20

Aspen Veterinary Resources, Ltd.

Labeler -

Aspen Veterinary Resources, Ltd. (627265361)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro ra Pharmaceutical, Inc.

8 328 48 6 39

ma nufa c ture

Revised: 11/2019

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