NITRO ZONE- nitrofurazone dressing

Nitro Zone by

Drug Labeling and Warnings

Nitro Zone by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

NADA 140-851, Approved by FDA    NDC # 46066-449-59

NITRO ZONE®

FOR USE IN DOGS, CATS & HORSES (NOT FOR FOOD USE).

An antibacterial Preparation for Topical Application.

CAUTION: Federal law prohibits the use of this product in food producing animals.

first Companion® Veterinary Products

USE IN SPECIFIC POPULATIONS

​FOR ANIMAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

​CONTENTS:

0.2% Nitrofurazone in a water-soluble base.

INDICATIONS:

Nitro Zone® is a water soluble antibacterial ointment for the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers. For use only on dogs, cats and horses (not for food use).

DIRECTIONS FOR USE:

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 contant 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.

CAUTION:

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 and consult a veterinarian.

WARNINGS

HUMAN WARNINGS:

CARCINOGENESIS: NITROFURAZONE HAS BEEN SHOWN TO PRODUCE 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.

WARNING: Do not use on horses intended for food.

STORAGE AND HANDLING

Store at controlled room temperature between 20°C-25°C (68°F-77°F) and protect from light. Avoid excessive heat (104°F) and exposure to alkaline materials.

SPL UNCLASSIFIED SECTION

Distributed by:

Aspen Veterinary Resources®, Ltd.

Liberty, MO 64068, USA

FC125NEO 10/13

Manufactured by:

 Neogen Corporation

Lexington, KY 40511

​PRINCIPAL DISPLAY PANEL - 1 lb

NDC: 46066-449-59

​NITRO ZONE®

​CAUTION: ​ Federal law prohibits the use of this product in food producing animals.

​first Companion® Veterinary Products

Net Contents: 1 POUND (0.45 KG)

INGREDIENTS AND APPEARANCE

NITRO ZONE 
nitrofurazone dressing

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-449
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROFURAZONE (UNII: X8XI70B5Z6) (NITROFURAZONE - UNII:X8XI70B5Z6)	NITROFURAZONE	0.908 g  in 454 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-449-59	454 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140851	07/22/2013

Labeler - Aspen Veterinary Resources, Ltd (627265361)