Nitrozone Ointment

Dosage Form: FOR ANIMAL USE ONLY
NITROZONE SOLUBLE DRESSING

INDICATIONS:

For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers.

ADMINISTRATION:

Apply directly on the lesion with a spatula, or first place on a piece of gauze. Application of a bandage is optional.

This preparation should be in contact with the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period.

PRECAUTION:

In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use, reconsult veterinarian. Avoid exposure to alkaline material and fluorescent lighting.

KEEP AWAY FROM EXCESSIVE HEAT OR DIRECT SUNLIGHT.

CONTENTS:

0.2% Nitrofurazone in a Water-soluble base of Polyethylene Glycols.

HUMAN WARNINGS:

CARCINOGENESIS: NITROFURAZONE, THE ACTIVE INGREDIENT OF NITROFURAZONE SOLUBLE DRESSING, HAS BEEN SHOWN TO PROOUCE MAMMARY TUMORS IN RATS AND OVARIAN TUMORS IN MICE.

SOME PEOPLE MAY BE HYPERSENSITIVE TO THIS PRODUCT. EITHER WEAR GLOVES WHEN APPLYING, OR WASH HANDS AFTERWARDS.

STORAGE:

Store at controlled room temperature between 15°-30°C (59°-86°F).  Keep container tightly closed when not In use.

DISPLAY PANEL

For Use In Horses Only


An Antibacterial Preparation for Topical Application


CAUTION: FEDERAL LAW PROHIBITS THE USE OF THIS PRODUCT IN FOOD-PRODUCING ANIMALS.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Manufactured For:  First Companion Veterinary Proudcts, Westlake, TX 76262, U.S.A.

Iss. 09 - 09                             

NET CONTENTS:

1 lb (453.6 g)

IMAGE OF JAR LABEL

IMAGE OF JAR LABEL

IMAGE OF CASE LABEL

NITROZONE  SOLUBLE DRESSING nitrofurazone  ointment

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 64556-292 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROFURAZONE (NITROFURAZONE) NITROFURAZONE 0.2 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color yellow (YELLOW) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64556-292-16 12 JAR In 1 CASE contains a JAR 1 453.6 g In 1 JAR This package is contained within the CASE (64556-292-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200425	09/01/2009

Labeler - FIRST COMPANION VETERINARY PRODUCTS (059580480)

Revised: 09/2009FIRST COMPANION VETERINARY PRODUCTS