BARRIER LIVESTOCK WOUND CARE - povidone-iodine, alcohol and denatonium benzoate solution
Aurora Pharmaceutical LLC

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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INDICATIONS

use in cattle, sheep and swine. Kills 99% of
surface germs in 15 seconds or less that can potentially cause
an infection. For use in animals as an aid in reducing chewing
on wounds and surgical incisions.

ACTIVE INGREDIENTS	PURPOSE
Povidone-Iodine (2% available iodine)	Antiseptic
Lidocaine 2% w/v	Pain Relief
Ethyl Alcohol – less than 80%	Antiseptic
Isopropyl Alcohol – less than 5%	Antiseptic

DIRECTIONS

Hold sprayer about 4–6 inches from area to be treated. Spray 1 or more times — allow to dry. Repeat as needed. Forms a highly visible coating that is durable.

WARNINGS

Do not use on food-producing animals less than one week prior to slaughter. Do not use in the eyes. Do not use if you are allergic to povidone-iodine. Prolonged exposure may cause irritation. If swallowed, get medical help or contact a Poison Control Center right away.

Store at 15°–30° C (59°–86° F). Avoid inhalation.

FLAMMABLE — USE WITH CAUTION

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

WET HAIR OR FUR IS FLAMMABLE

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057

PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label

NDC 51072-034-16

BARRIER

Livestock Wound Care
2% Available Iodine

For Veterinary Use Only
16 fl. oz. (473 ml)

aurora
PHARMACEUTICAL

Principal Display Panel - 473 ml Bottle Label

BARRIER LIVESTOCK WOUND CARE
povidone-iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:51072-034
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (POVIDONE-IODINE)	POVIDONE-IODINE	20 g in 100 mL
ALCOHOL (ALCOHOL)	ALCOHOL	65.53 g in 100 mL
DENATONIUM BENZOATE (BENZOIC ACID)	DENATONIUM BENZOATE	2.1 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN	2 g in 100 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	GRAPEFRUIT (grapefruit ginger fragrance)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51072-034-16	473.2 mL in 1 BOTTLE, SPRAY	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/20/2011

Labeler - Aurora Pharmaceutical LLC (832848639)

Establishment
Name	Address	ID/FEI	Operations
Aurora Pharmaceutical LLC		832848639	manufacture

Establishment
Name	Address	ID/FEI	Operations
BASF Corporation		623867848	api manufacture

Revised: 11/2011 Aurora Pharmaceutical LLC