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Barrier II

Aurora Pharmaceutical LLC

BARRIER II Wound Care Spray With Pain Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 INGREDIENTS PURPOSE
Povidone-Iodine (2% available iodine) Antiseptic
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

REORDER
NO: 19004

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MN 55057
888-215-1256
www.aurorapharmaceutical.com

IN 50-1121 REV 02

MANUFACTURED IN THE USA

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

Barrier II

Barrier II

Povidone-Iodine, Alcohol, and Lidocaine SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:51072-041
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POVIDONE-IODINE IODINE 2 g
ALCOHOL ALCOHOL 64.71 g
LIDOCAINE LIDOCAINE 2.1 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 473.2 in 1 BOTTLE, SPRAY
2 946.4 in 1 BOTTLE, SPRAY
3 NDC:51072-041-00 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-28


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