BARRIER WATERLESS SURGICAL PREP - povidone-iodine, alcohol 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.

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INDICATIONS

For use in cattle, sheep and swine as an aid in reducing surface bacteria. Barrier™ Waterless Surgical Prep provides rapid antimicrobial kill of a broad spectrum of microorganisms, including antibiotic-resistant strains, with greater than 99% microbial kill in 15 seconds or less.

ACTIVE INGREDIENTSPURPOSE
Povidone-Iodine
   (2% available iodine)		Antiseptic
Ethyl Alcohol 80.6% v/vAntiseptic
Isopropyl Alcohol 4.0% v/vAntiseptic

DIRECTIONS

Closely clip hair from surgical site. Hold sprayer about 4–6 inches from area to be treated. Spray 1 or more times — allow to dry. Surgical incision can then be made through the durable antibacterial Barrier™ protection.

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.

FLAMMABLE — USE WITH CAUTION
FOR EXTERNAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

REORDER NO: 59001

MANUFACTURED
IN THE USA

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
507-645-3225
www.aurorapharmaceutical.com
IN 50-1074 REV 00

PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label

NDC 51072-035-16

BARRIER™

Waterless Surgical Prep

Povidone-Iodine

2% Available Iodine

For Veterinary Use Only

16 fl. oz. (473 ml)

aurora
PHARMACEUTICAL

Principal Display Panel - 473 ml Bottle Label

BARRIER  WATERLESS SURGICAL PREP
povidone-iodine, alcohol, isopropyl alcohol solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE20 g  in 100 mL
ALCOHOL (ALCOHOL) ALCOHOL63.8 g  in 100 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL3.4 g  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEFRUIT (GRAPEFRUIT GINGER) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:51072-035-16473.2 mL in 1 BOTTLE, SPRAYNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/20/201011/30/2012

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

Revised: 01/2013 Aurora Pharmaceutical LLC