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.

----------

For Animal Use Only

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 INGREDIENTS

Active Ingredients                         Purpose
Povidone-Iodine (2% available iodine)        Antiseptic
Bitrex™ Denatonium Benzoate                 Bitter Agent
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 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.

(1) FLAMMABLE - USE WITH CAUTION

(2) FOR EXTERNAL USE ONLY

(3) KEEP OUT OF REACH OF CHILDREN

(4) WET HAIR OR FUR IS FLAMMABLE

(5) CONSUMER COMMODITY ORM-D

Manufactured by:
Aurora Pharmaceutical, LLC
Northfield, Minnesota 55057


PRINCIPAL DISPLAY PANEL

Barrier

Wound Care Spray

With Pain Relief


2% Available Iodine with Lidocaine

(Patent pending)

For Animal Use Only

16 fl. oz. (473 ml)

Principal Display Panel - 473 ml Bottle Label




BARRIER  WOUND CARE WITH PAIN RELIEF
povidone-iodine, alcohol, lidocaine, bitrex solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-036
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (IODINE) Povidone-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 DescriptionMultilevel Packaging
1NDC:51072-036-00946.4 mL in 1 BOTTLE, SPRAYNone
2NDC:51072-036-16473.2 mL in 1 BOTTLE, SPRAYNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2010

Labeler - Aurora Pharmaceutical LLC (832848639)
Establishment
NameAddressID/FEIOperations
Aurora Pharmaceutical LLC832848639manufacture

Revised: 08/2012 Aurora Pharmaceutical LLC