BARRIER II  WOUND CARE PAIN RELIEF - povidone-iodine, alcohol and lidocaine 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 topical use on animals as an aid in preventing infection and reducing pain. 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
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 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 51072-041-16

BARRIER II™

Wound Care Spray
With Pain Relief
2% Available Iodine with Lidocaine
(Patent pending)

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

aurora
PHARMACEUTICAL

Principal Display Panel - 473 ml Bottle Label

BARRIER II   WOUND CARE PAIN RELIEF
povidone-iodine, alcohol, and lidocaine solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-041
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE20 g  in 100 mL
ALCOHOL (ALCOHOL) ALCOHOL64.71 g  in 100 mL
LIDOCAINE (LIDOCAINE) LIDOCAINE2.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN2 g  in 100 mL
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorGRAPEFRUIT (grapefruit ginger fragrance) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:51072-041-1612 BOTTLE, SPRAY ( BOTTLE) in 1 CARTONcontains a BOTTLE, SPRAY
1473.2 mL in 1 BOTTLE, SPRAYThis package is contained within the CARTON (51072-041-16)
2NDC:51072-041-006 BOTTLE, SPRAY ( BOTTLE) in 1 CARTONcontains a BOTTLE, SPRAY
2946.4 mL in 1 BOTTLE, SPRAYThis package is contained within the CARTON (51072-041-00)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/28/2011

Labeler - Aurora Pharmaceutical LLC (832848639)

Revised: 05/2012 Aurora Pharmaceutical LLC