Nitrotop Dressing

Generic Name: nitrofurazone dressing

Dosage Form: FOR ANIMAL USE ONLY

INDICATIONS:  For the prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers.  For use only on dogs, cats and horses.

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.

CAUTION:  In case of deep or puncture wounds or serious burns consult veterinarian.  If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian.

HUMAN WARNINGS:  Carcinogenesis:  Nitrofurazone, the active ingredient of Nitrotop Dressing has been shown to produce mammary tumors in rats and ovarian tumors in mice.

Additionally some people may be hypersensitive to this product.

Either wear gloves when applying, or wash hands afterwards.

Avoid exposure to excessive heat or direct sunlight and strong fluorescent lighting.

Not to be used on animals intended for food purposes.

BUTLER SCHEIN ANIMAL HEALTH

A Henry Schein Company

NDC #11695-4004-1

NITROTOP

(Brand of Nitrofurazone Soluble Dressing)

FOR USE ONLY ON DOGS, CATS AND HORSES

Federal law prohibits the extralabel use of  this drug in food-producing animals.

WARNING:  DO NOT USE ON HORSES INTENDED FOR HUMAN CONSUMPTION

AN ANTIBACTERIAL PREPARATION FOR TOPICAL APPLICATION

Contents:  0.2% Nitrofurazone in a Water Soluble Base of Polyethylene Glycols.

Keep Out of Reach of Children

NADA 122-447, Approved by FDA

Net Weight:  1 Pound

NITROTOP  nitrofurazone  dressing

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 11695-4004 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nitrofurazone (Nitrofurazone) Nitrofurazone 0.907 g  in 453.6 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11695-4004-1 453.6 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA122447	07/09/2009

Labeler - Butler Animal Health Supply (017880659)

Registrant - Bimeda, Inc. (043653216)

Establishment
Name	Address	ID/FEI	Operations
Centaur, Inc.		174239087	manufacture

Revised: 10/2010Butler Animal Health Supply