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

  • NDC Code(s): 51072-041-00, 51072-041-01, 51072-041-16
  • Packager: Aurora Pharmaceutical, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 3, 2023

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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.

  • DESCRIPTION

    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 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 upright at 15°–25° C (59°–77° F). Brief excursions up to 40° C (104° F) are permitted.

  • 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

    Limited Quantity

  • SPL UNCLASSIFIED SECTION

    Take time

    REORDER

    NO: 19004

    MANUFACTURED BY:
    Aurora Pharmaceutical, Inc.
    NORTHFIELD, MN 55057
    1-888-215-1256
    www.aurorapharmaceutical.com

    IN 50-1121 06/2023

    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

    Does Not Contain Bitrex

    (Patent pending)

    For Veterinary Use Only

    16 fl. oz. (473 ml)

    AURORA PHARMACEUTICAL ®

    473 ml Bottle Label

  • INGREDIENTS AND APPEARANCE
    BARRIER II WOUND CARE  WITH PAIN RELIEF
    povidone-iodine, lidocaine, and alcohol solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine2 g  in 100 mL
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine2 g  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL5 mL  in 100 mL
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51072-041-16473 mL in 1 BOTTLE
    2NDC:51072-041-00946 mL in 1 BOTTLE
    3NDC:51072-041-013790 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER03/28/2011
    Labeler - Aurora Pharmaceutical, Inc. (832848639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurora Pharmaceutical, Inc.832848639MANUFACTURE