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Aurora Pharmaceutical LLC

BARRIER Wound Care Spray With Pain Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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 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®

Barrier

Barrier

Povidone-Iodine, Alcohol, Lidocaine, Bitrex SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:51072-036
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POVIDONE-IODINE IODINE 20 g
ALCOHOL ALCOHOL 64.1 g
LIDOCAINE LIDOCAINE 2.04 g
denatonium benzoate 1.27 g
ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL 5 mL

Product Characteristics

Color
brown (brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51072-036-00 946.4 in 1 BOTTLE, SPRAY
2 NDC:51072-036-16 473.2 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-10-15


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