BARRIER WOUND CARE WITH PAIN RELIEF- povidone-iodine, alcohol, lidocaine, denatonium benzoate and isopropyl alcohol 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.

----------

BARRIER®
Wound Care Spray
With Pain Relief

INDICATIONS

For topical use on animals as an aid in reducing pain, licking and chewing on wounds and surgical incisions. Kills up to 99% of surface germs in 15 seconds or less that can potentially cause an infection.

ACTIVE INGREDIENTSPURPOSE
Povidone-Iodine (2% available iodine)Antiseptic
Bitrex™ Denatonium BenzoateBitter Agent
Lidocaine 2% w/vPain 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 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 20°–25° C (68°–77° F). Excursions permitted between 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
Consumer Commodity ORM-D

MANUFACTURED IN THE USA

REORDER NO: 19001

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1082 06/2013

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 51072-036-16

BARRIER®

Wound Care Spray
With Pain Relief

2% Available Iodine with Lidocaine

(Patent pending)

For Animal Use Only

16 fl. oz. (473 mL)

aurora
PHARMACEUTICAL®

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
BARRIER  WOUND CARE WITH PAIN RELIEF
povidone-iodine, alcohol, lidocaine, bitrex solution
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:51072-036
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (IODINE) IODINE20 g  in 100 mL
Alcohol (Alcohol) Alcohol64.1 g  in 100 mL
Lidocaine (Lidocaine) Lidocaine2.04 g  in 100 mL
Denatonium Benzoate (DENATONIUM) Denatonium Benzoate1.27 g  in 100 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL5 mL  in 100 mL
Product Characteristics
Colorbrown (brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51072-036-00946.4 mL in 1 BOTTLE, SPRAY
2NDC:51072-036-16473.2 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2010
Labeler - Aurora Pharmaceutical LLC (832848639)
Establishment
NameAddressID/FEIBusiness Operations
Aurora Pharmaceutical LLC832848639MANUFACTURE

Revised: 8/2013
Document Id: 9e451d59-3b39-4a72-b475-386267320adb
Set id: a4bd57d4-3161-4145-b744-b57bf2dd7e1a
Version: 5
Effective Time: 20130829
 
Aurora Pharmaceutical LLC