BARRIER WOUND CARE WITH PAIN RELIEF- povidone-iodine, lidocaine, and alcohol solution

Barrier Wound Care by

Drug Labeling and Warnings

Barrier Wound Care by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS

For topical use on animals as an aid in reducing pain, licking and chewing on wounds and surgical incisions.

DESCRIPTION

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 or sensitive to the active ingredients. 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.

BOXED WARNING

(What is this?)

FLAMMABLE — USE WITH CAUTION
FOR EXTERNAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
WET HAIR OR FUR IS FLAMMABLE
Consumer Commodity ORM-D

SPL UNCLASSIFIED SECTION

MANUFACTURED IN THE USA

REORDER NO: 19001

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1082 04/2017

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®

INGREDIENTS AND APPEARANCE

BARRIER WOUND CARE  WITH PAIN RELIEF
povidone-iodine, lidocaine, and alcohol solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-Iodine (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	2 g  in 100 mL
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	2 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	5 mL  in 100 mL

Product Characteristics
Color	brown (brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-036-16	473 mL in 1 BOTTLE
2	NDC: 51072-036-01	3790 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/15/2010

Labeler - Aurora Pharmaceutical, Inc. (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Pharmaceutical, Inc.		832848639	MANUFACTURE