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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For Veterinary Use Only

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 INGREDIENTS AND PURPOSE

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

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.

(1) FLAMMABLE - USE WITH CAUTION

(2) FOR EXTERNAL USE ONLY

(3) KEEP OUT OF REACH OF CHILDREN


Store at 15° - 30° C (59° - 86° F)

Avoid inhalation

MANUFACTURER

Manufactured by:
Aurora Pharmaceutical, LLC
Northfield, Minnesota 55057

LABEL DISPLAY

NDC 51072-035-16

BARRIERTM

Waterless Surgical Prep
Povidone-Iodine
2% Available Iodine

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

Aurora Pharmaceutical LLC

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 (POVIDONE-IODINE) POVIDONE-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 other08/20/2010

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

Revised: 06/2012 Aurora Pharmaceutical LLC