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

Barrier II Wound Care by

Drug Labeling and Warnings

Barrier II 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 preventing infection and reducing pain. Kills up to 99% of surface germs in 15 seconds or less that can potentially cause an infection.

DESCRIPTION

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

Pour into a spray bottle dialed to spray pattern, 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 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. Avoid inhalation.

STORAGE AND HANDLING

Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.

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

DOT Name: Ethanol Solutions UN1170,3,PGII

SPL UNCLASSIFIED SECTION

REORDER
NO: 19005

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

IN 50-1122 11/2017

MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

NDC: 51072-041-00

BARRIER II®

Wound Care Spray

With Pain Relief

2% Available Iodine with Lidocaine

Does Not Contain Bitrex

(Patent pending)

For Veterinary Use Only

32 fl. oz. (946 ml)

AURORA PHARMACEUTICAL ®

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-041
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	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-041-16	473 mL in 1 BOTTLE
2	NDC: 51072-041-00	946 mL in 1 BOTTLE
3	NDC: 51072-041-01	3790 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/28/2011

Labeler - Aurora Pharmaceutical, Inc. (832848639)

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