<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="469cb234-b038-4a94-818a-c513ba2399ff"/>
   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <title>Barrier<sup>®</sup> for Dogs<br/>(imidacloprid+moxidectin)<br/>Topical Solution</title>
   <effectiveTime value="20251211"/>
   <setId root="2aca52b5-298f-427e-86d1-80a4eb1a771e"/>
   <versionNumber value="7"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="832848639" root="1.3.6.1.4.1.519.1"/>
            <name>Aurora Pharmaceutical, Inc.</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="832848639" root="1.3.6.1.4.1.519.1"/>
                        <name>Aurora Pharmaceutical, Inc.</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="manufacture"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section ID="dcl-dpl">
               <id root="22b47f89-92b9-42f1-9833-1eb70a732b87"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
               <effectiveTime value="20221025"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="51072-100" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>BARRIER FOR DOGS</name>
                        <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SOLUTION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>IMIDACLOPRID, MOXIDECTIN</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="100" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="3BN7M937V8" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>IMIDACLOPRID</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="3BN7M937V8" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>IMIDACLOPRID</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="25" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="NGU5H31YO9" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MOXIDECTIN</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="NGU5H31YO9" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>MOXIDECTIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="0.4" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="6" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="51072-100-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="1.0" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="6" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="51072-100-02" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="2.5" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="6" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="51072-100-03" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="4.0" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="6" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="51072-100-04" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="5.0" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="6" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="51072-100-05" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20221026"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="ANADA200718" root="2.16.840.1.113883.3.150"/>
                           <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="s1">
               <id root="d26afb94-21d6-476a-8dbe-11905df46be0"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Once-a-month topical solution for the prevention of heartworm disease, the treatment of circulating microfilariae, kills adult fleas, is indicated for the treatment of flea infestations, the treatment and control of sarcoptic mange, as well as the treatment and control of intestinal parasite infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20251211"/>
            </section>
         </component>
         <component>
            <section ID="s2">
               <id root="05fb821a-dc0c-4e67-98e0-0ab9088434bd"/>
               <code code="34066-1" codeSystem="2.16.840.1.113883.6.1" displayName="BOXED WARNING SECTION"/>
               <title>WARNING
</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>
                        <content styleCode="bold">DO NOT ADMINISTER THIS PRODUCT ORALLY</content>
                     </item>
                     <item>
                        <content styleCode="bold">For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.</content>
                     </item>
                     <item>
                        <content styleCode="bold">Children should not come in contact with application sites for two (2) hours after application.</content>
                     </item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">(See <linkHtml href="#s6">Contraindications</linkHtml>, <linkHtml href="#s7">Warnings</linkHtml>, <linkHtml href="#s8">Human Warnings</linkHtml>, and <linkHtml href="#s10">Adverse Reactions</linkHtml>, for more information)</content>
                  </paragraph>
               </text>
               <effectiveTime value="20250616"/>
            </section>
         </component>
         <component>
            <section ID="s3">
               <id root="1ae1f3ed-f4aa-43f2-b6c1-4831f3885c64"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>CAUTION:
</title>
               <text>
                  <paragraph>Federal Law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s4">
               <id root="cf8b090d-aab9-43cf-9a7f-2ae77efc000d"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION:
</title>
               <text>
                  <paragraph>
                     <content styleCode="italics">Barrier for Dogs</content> (10 % imidacloprid + 2.5 % moxidectin) is a colorless to yellow ready-to-use solution packaged in single dose applicator tubes for topical treatment of dogs. The formulation and dosage schedule are designed to provide a minimum of 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin based on body weight.</paragraph>
                  <paragraph>Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The chemical name for imidacloprid is 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine. Moxidectin is a semisynthetic macrocyclic lactone endectocide derived from the actinomycete <content styleCode="italics">Streptomycetes cyaneogriseus noncyanogenus</content>. The chemical name for moxidectin is [6R, 23E, 25S(E)]-5-0- Demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino) milbemycin B.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s5">
               <id root="52cb1624-f2d6-4c69-878d-88b6f20868a4"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>INDICATIONS:
</title>
               <text>
                  <paragraph>
                     <content styleCode="italics">Barrier for Dogs</content> is indicated for the prevention of heartworm disease caused by <content styleCode="italics">Dirofilaria immitis</content> and the treatment of <content styleCode="italics">Dirofilaria immitis</content> circulating microfilariae in heartworm-positive dogs. <content styleCode="italics">Barrier for Dogs</content> kills adult fleas and is indicated for the treatment of flea infestations (<content styleCode="italics">Ctenocephalides felis</content>). <content styleCode="italics">Barrier for Dogs</content> is indicated for the treatment and control of sarcoptic mange caused by <content styleCode="italics">Sarcoptes scabiei</content> var. <content styleCode="italics">canis. Barrier for Dogs</content> is also indicated for the treatment and control of the following intestinal parasites:</paragraph>
                  <table width="100%">
                     <colgroup>
                        <col width="27.800%" align="left"/>
                        <col width="31.940%" align="left"/>
                        <col width="8.380%" align="left"/>
                        <col width="21.880%" align="left"/>
                        <col width="10.000%" align="left"/>
                     </colgroup>
                     <tbody>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule Toprule" rowspan="2" colspan="2" align="center" valign="middle">
                              <content styleCode="bold">Intestinal Parasite</content>
                           </td>
                           <td styleCode="Botrule Rrule Toprule" colspan="3" align="center" valign="top">
                              <content styleCode="bold">Intestinal Stage</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Rrule" align="center" valign="middle">
                              <content styleCode="bold">Adult</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="middle">
                              <content styleCode="bold">Immature Adult</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="middle">
                              <content styleCode="bold">Fourth</content>
                              <br/>
                              <content styleCode="bold">Stage</content>
                              <br/>
                              <content styleCode="bold">Larvae</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" rowspan="2" align="left" valign="middle">Hookworm Species</td>
                           <td styleCode="Botrule Rrule" align="left" valign="top">
                              <content styleCode="italics">Ancylostoma caninum</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Rrule" align="left" valign="top">
                              <content styleCode="italics">Uncinaria stenocephala</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" rowspan="2" align="left" valign="top">Roundworm Species</td>
                           <td styleCode="Botrule Rrule" align="left" valign="top">
                              <content styleCode="italics">Toxocara canis</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="left" valign="top"/>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Rrule" align="left" valign="top">
                              <content styleCode="italics">Toxascaris leonina</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="left" valign="top"/>
                           <td styleCode="Botrule Rrule" align="left" valign="top"/>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" align="left" valign="top">Whipworm</td>
                           <td styleCode="Botrule Rrule" align="left" valign="top">
                              <content styleCode="italics">Trichuris vulpis</content>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">X</td>
                           <td styleCode="Botrule Rrule" align="left" valign="top"/>
                           <td styleCode="Botrule Rrule" align="left" valign="top"/>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s17">
               <id root="0db129dd-5fdc-480d-9860-fd5b0d829e5c"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE AND ADMINISTRATION:
</title>
               <text>
                  <paragraph>The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration.</paragraph>
                  <paragraph>Do not apply to irritated skin.</paragraph>
                  <list listType="ordered" styleCode="Arabic">
                     <item>Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the <content styleCode="italics">Barrier for Dogs (</content>﻿imidacloprid + moxidectin) tube that correctly corresponds with the body weight of the dog.<table width="100%">
                           <colgroup>
                              <col width="11.820%" align="left"/>
                              <col width="23.540%" align="left"/>
                              <col width="16.840%" align="left"/>
                              <col width="25.080%" align="left"/>
                              <col width="22.720%" align="left"/>
                           </colgroup>
                           <tfoot>
                              <tr styleCode="First Last">
                                 <td colspan="4" align="left" valign="top">
                                    <paragraph styleCode="First Footnote">* Dogs over 110 lbs. should be treated with the appropriate combination of <content styleCode="italics">Barrier for Dogs</content> tubes.</paragraph>
                                 </td>
                              </tr>
                           </tfoot>
                           <tbody>
                              <tr>
                                 <td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="middle">
                                    <content styleCode="bold">Dog (lbs.)</content>
                                 </td>
                                 <td styleCode="Botrule Rrule Toprule" align="center" valign="middle">
                                    <content styleCode="bold">Volume (mL)</content>
                                 </td>
                                 <td styleCode="Botrule Rrule Toprule" align="center" valign="middle">
                                    <content styleCode="bold">Imidacloprid (mg)</content>
                                 </td>
                                 <td styleCode="Botrule Rrule Toprule" align="center" valign="middle">
                                    <content styleCode="bold">Moxidectin (mg)</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td styleCode="Botrule Lrule Rrule" align="left" valign="top">3–9</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">0.4</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">40</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">10</td>
                              </tr>
                              <tr>
                                 <td styleCode="Botrule Lrule Rrule" align="left" valign="top">9.1–20</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">1.0</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">100</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">25</td>
                              </tr>
                              <tr>
                                 <td styleCode="Botrule Lrule Rrule" align="left" valign="top">20.1–55</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">2.5</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">250</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">62.5</td>
                              </tr>
                              <tr>
                                 <td styleCode="Botrule Lrule Rrule" align="left" valign="top">55.1–88</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">4.0</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">400</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">100</td>
                              </tr>
                              <tr>
                                 <td styleCode="Botrule Lrule Rrule" align="left" valign="top">88.1–110*</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">5.0</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">500</td>
                                 <td styleCode="Botrule Rrule" align="center" valign="top">125</td>
                              </tr>
                           </tbody>
                        </table>
                        <renderMultiMedia referencedObject="L613e8a60-7213-4d4e-aea1-ef4e1c045788"/>
                     </item>
                     <item>While holding the tube in an upright position, twist the cap to break the seal and apply. The cap will remain on the tube.</item>
                  </list>
                  <paragraph>
                     <renderMultiMedia referencedObject="L666bae89-ac9a-46b9-bcd5-84195e9e18e5"/>
                  </paragraph>
                  <paragraph>3. The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lea69c584-0e4c-448f-b9a5-e689344e4f34"/>
                  </paragraph>
                  <paragraph>Do not let this product get in your dog's mouth or eyes. <content styleCode="bold">Do not allow the dog to lick any of the application sites for 30 minutes.</content> In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. <content styleCode="bold">(See <linkHtml href="#s7">WARNINGS</linkHtml>.)</content>
                  </paragraph>
                  <paragraph>Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product.</paragraph>
                  <paragraph>Shampooing 90 minutes after treatment does not reduce the effectiveness of <content styleCode="italics">Barrier for Dogs</content> in the prevention of heartworm disease.</paragraph>
                  <paragraph>Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of <content styleCode="italics">Barrier for Dogs</content> in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas.</paragraph>
               </text>
               <effectiveTime value="20251211"/>
               <component>
                  <section ID="s18">
                     <id root="ac1cbe3e-f196-43c1-8cd0-4c512f5dc282"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Heartworm Prevention</content>: For prevention of heartworm disease, Barrier for Dogs should be administered at one-month intervals. Barrier for Dogs may be administered year-round or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer Barrier for Dogs immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with Barrier for Dogs should be given within one month of the last dose of the former medication.</paragraph>
                     </text>
                     <effectiveTime value="20251211"/>
                  </section>
               </component>
               <component>
                  <section ID="s19">
                     <id root="35b9490f-b3ae-4830-8933-56f19d7def25"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Treatment of Circulating Microfilaria:</content> For the treatment of circulating <content styleCode="italics">D. immitis</content> microfilaria in heartworm-positive dogs, <content styleCode="italics">Barrier for Dogs</content> should be administered at one-month intervals. Treatment with an approved adulticide therapy is recommended because<content styleCode="italics"> Barrier for Dogs</content> is not effective for the treatment of adult <content styleCode="italics">D. immitis</content>. <content styleCode="bold">(See <linkHtml href="#s9">PRECAUTIONS</linkHtml>.)</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20251209"/>
                  </section>
               </component>
               <component>
                  <section ID="s20">
                     <id root="1857ac50-5d46-4ec9-866c-ba7b741223a8"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Flea Treatment:</content> For the treatment of flea infestations, <content styleCode="italics">Barrier for Dog</content>s should be administered at one-month intervals. If the dog is already infested with fleas when the first dose of<content styleCode="italics"> Barrier for Dogs</content> is administered, adult fleas on the dog will be killed. However, reinfestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated. Dogs treated with imidacloprid, including those with pre-existing flea allergy dermatitis have shown clinical improvement as a direct result of elimination of fleas from the dog.</paragraph>
                     </text>
                     <effectiveTime value="20251209"/>
                  </section>
               </component>
               <component>
                  <section ID="s21">
                     <id root="c3d6903b-81e1-4c7c-a5e5-d1d43ce934b8"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Treatment and Control of Intestinal Nematode Infections:
</title>
                     <text>
                        <paragraph>For the treatment and control of intestinal hookworm infections caused by <content styleCode="italics">Ancylostoma caninum</content> and <content styleCode="italics">Uncinaria stenocephala</content> (adults, immature adults and fourth stage larvae) and roundworm infections caused by <content styleCode="italics">Toxocara canis</content> (adults and fourth stage larvae), and <content styleCode="italics">Toxascaris leonina</content> (adults), and whipworm infections caused by <content styleCode="italics">Trichuris vulpis</content> (adults), <content styleCode="italics">Barrier for Dogs</content> should be administered once as a single topical dose.</paragraph>
                     </text>
                     <effectiveTime value="20251209"/>
                     <component>
                        <section ID="s22">
                           <id root="c4e1dd3b-b828-480e-b888-1393e16d2b3a"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Treatment and Control of Sarcoptic Mange:</content> For the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis, Barrier for Dogs should be administered as a single topical dose. A second monthly dose may be administered if necessary.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                  </section>
               </component>
               <component>
                  <observationMedia ID="L613e8a60-7213-4d4e-aea1-ef4e1c045788">
                     <text>Cap Removal</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Cap Removal.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L666bae89-ac9a-46b9-bcd5-84195e9e18e5">
                     <text>Neck Application</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Neck Application.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Lea69c584-0e4c-448f-b9a5-e689344e4f34">
                     <text>Application2</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Application2.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="s6">
               <id root="8e9a057b-f460-47ca-aaaa-8cecaf4b1333"/>
               <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/>
               <title>CONTRAINDICATIONS:
</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Do not administer this product orally. (See <linkHtml href="#s7">WARNINGS</linkHtml>.)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Do not use this product (containing 2.5 % moxidectin) on cats.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s7">
               <id root="35b648a4-e02b-49f8-8a0e-9197032e23b6"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNINGS
</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">For the first 30 minutes after application:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Ensure that dogs cannot lick the product from application sites on themselves or other treated dogs, and</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Separate treated dogs from one another and from other pets to reduce the risk of accidental ingestion.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Ingestion of this product by dogs may cause serious adverse reactions including depression, salivation, dilated pupils, incoordination, panting, and generalized muscle tremors.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">In avermectin sensitive dogs,</content>
                     <content styleCode="bold">
                        <sup>a </sup>
                     </content>
                     <content styleCode="bold">the signs may be more severe and may include coma and death.</content>
                     <content styleCode="bold">
                        <sup>b</sup>
                     </content>
                  </paragraph>
                  <paragraph>
                     <sup>a</sup> Some dogs are more sensitive to avermectins due to a mutation in the MDR1 gene. Dogs with this mutation may develop signs of severe avermectin toxicity if they ingest this product. The most common breeds associated with this mutation include Collies and Collie crosses.</paragraph>
                  <paragraph>
                     <sup>b</sup> Although there is no specific antagonist for avermectin toxicity, even severely affected dogs have completely recovered from avermectin toxicity with intensive veterinary supportive care.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s8">
               <id root="1cd5da75-8936-4bc0-bfce-8bf829df5d51"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>HUMAN WARNINGS:
</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Not for human use. Keep out of the reach of children.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Children should not come in contact with application sites for two (2) hours after application.</content>
                  </paragraph>
                  <paragraph>Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. <content styleCode="bold">Wash hands thoroughly with soap and warm water after handling.</content>
                  </paragraph>
                  <paragraph>If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In case of allergic reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with plenty of soap and water. Call a poison control center or physician for treatment advice.</paragraph>
                  <paragraph>The Safety Data Sheet (SDS) provides additional occupational safety information. For a copy of the Safety Data Sheet (SDS) or to report adverse drug experiences, or consumer questions call Aurora Pharmaceutical at 1-888-215-1256. </paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s9">
               <id root="19a78c15-4bec-47c1-a1ca-73324b588d60"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS:
</title>
               <text>
                  <paragraph>Do not dispense dose applicator tubes without complete safety and administration information.</paragraph>
                  <paragraph>Use with caution in sick, debilitated, or underweight animals. The safety of <content styleCode="italics">Barrier for Dogs</content> has not been established in breeding, pregnant, or lactating dogs. The safe use of <content styleCode="italics">Barrier for Dogs</content> has not been established in puppies and dogs less than 7 weeks of age or less than 3 lbs. body weight.</paragraph>
                  <paragraph>Prior to administration of <content styleCode="italics">Barrier for Dogs</content>, dogs should be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of <content styleCode="italics">Barrier for Dogs</content> has not been evaluated when administered on the same day as an adulticide. <content styleCode="italics">Barrier for Dogs</content> is not effective against adult <content styleCode="italics">D. immitis</content>. Although the number of circulating microfilariae is substantially reduced in most dogs following treatment with <content styleCode="italics">Barrier for Dogs</content>, the microfilaria count in some heartworm-positive dogs may increase or remain unchanged following treatment with <content styleCode="italics">Barrier for Dogs</content> alone or in a dosing regimen with melarsomine dihydrochloride.</paragraph>
                  <paragraph>
                     <content styleCode="bold">(See <linkHtml href="#s10">ADVERSE REACTIONS</linkHtml> and <linkHtml href="#s32">ANIMAL SAFETY – Safety Study in Heartworm-Positive Dogs</linkHtml>.)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">Barrier for Dogs</content> has not been evaluated in heartworm-positive dogs with Class 4 heartworm disease.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s10">
               <id root="d8a68b8f-7093-4b5a-abe1-65c528b215fb"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <title>ADVERSE REACTIONS:
</title>
               <effectiveTime value="20251209"/>
               <component>
                  <section ID="s11">
                     <id root="b7eea890-98a0-4771-a784-6b93f3eab095"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Heartworm-Negative Dogs
</title>
                     <effectiveTime value="20251209"/>
                     <component>
                        <section ID="s12">
                           <id root="1d4b9281-1027-4b21-8c67-8f9bf9da9fd3"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Field Studies:</content> Following treatment with <content styleCode="italics">imidacloprid and moxidectin</content> or an active control, dog owners reported the following post-treatment reactions:</paragraph>
                              <table width="100%">
                                 <colgroup>
                                    <col width="25.367%" align="left"/>
                                    <col width="40.267%" align="left"/>
                                    <col width="34.367%" align="left"/>
                                 </colgroup>
                                 <tbody>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top">
                                          <content styleCode="bold">OBSERVATION</content>
                                       </td>
                                       <td styleCode="Botrule Rrule Toprule" align="center" valign="top">
                                          <content styleCode="bold">Imidacloprid and Moxidectin Topical n = 128</content>
                                       </td>
                                       <td styleCode="Botrule Rrule Toprule" align="center" valign="top">
                                          <content styleCode="bold">Active Control n = 68</content>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Pruritus</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">19 dogs (14.8 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">7 dogs (10.3 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Residue</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">9 dogs (7.0 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">5 dogs (7.4 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Medicinal Odor</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">5 dogs (3.9 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">None observed</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Lethargy</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 dog (0.8 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 dog (1.5 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Inappetence</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 dog (0.8 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 dog (1.5 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Hyperactivity</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 dog (0.8 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">None observed</td>
                                    </tr>
                                 </tbody>
                              </table>
                              <paragraph>During a field study using 61 dogs with pre-existing flea allergy dermatitis, one (1.6 %) dog experienced localized pruritus immediately after imidacloprid application, and one investigator noted hyperkeratosis at the application site of one dog (1.6 %).</paragraph>
                              <paragraph>In a field safety and effectiveness study, imidacloprid and moxidectin was administered to 92 client-owned dogs with sarcoptic mange. The dogs ranged in age from 2 months to 12.5 years and ranged in weight from 3 to 231.5 pounds. Adverse reactions in dogs treated with imidacloprid and moxidectin  included hematochezia, diarrhea, vomiting, lethargy, inappetence, and pyoderma.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s13">
                           <id root="81a12f2f-ffbc-402d-b3cb-5df24c9c7ea4"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Laboratory Effectiveness Studies:</content> One dog in a laboratory effectiveness study experienced weakness, depression, and unsteadiness between 6 and 9 days after application with imidacloprid and moxidectin. The signs resolved without intervention by day 10 post-application. The signs in this dog may have been related to peak serum levels of moxidectin, which vary between dogs, and occur between 1 and 21 days after application of imidacloprid and moxidectin.</paragraph>
                              <paragraph>The following clinical observations also occurred in laboratory effectiveness studies following application with imidacloprid and moxidectin and may be directly attributed to the drug or may be secondary to the intestinal parasite burden or other underlying conditions in the dogs: diarrhea, bloody stools, vomiting, anorexia, lethargy, coughing, ocular discharge and nasal discharge. Observations at the application sites included damp, stiff or greasy hair, the appearance of a white deposit on the hair, and mild erythema, which resolved without treatment within 2 to 48 hours.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                  </section>
               </component>
               <component>
                  <section ID="s14">
                     <id root="f8378220-a7fa-4732-ab2f-1ab00b0e46e3"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Heartworm-Positive Dogs
</title>
                     <effectiveTime value="20251209"/>
                     <component>
                        <section ID="s15">
                           <id root="8673fe75-2b9e-4c36-a39e-596a887da5b1"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Field Study:</content> A 56-day field safety study was conducted in 214 <content styleCode="italics">D. immitis</content> heartworm and microfilaria positive dogs with Class 1, 2 or 3 heartworm disease. All dogs received imidacloprid and moxidectin on Study Days 0 and 28; 108 dogs also received melarsomine dihydrochloride on Study Days – 14, 14, and 15. All dogs were hospitalized for a minimum of 12 hours following each treatment. Effectiveness against circulating <content styleCode="italics">D. immitis</content> microfilariae was &gt; 90 % at five of six sites; however, one site had an effectiveness of 73.3 %. The microfilaria count in some heartworm-positive dogs increased or remained unchanged following treatment with imidacloprid and moxidectin alone or in a dosing regimen with melarsomine dihydrochloride.</paragraph>
                              <paragraph>Following treatment with imidacloprid and moxidectin alone or in a dosing regimen with melarsomine dihydrochloride, the following adverse reactions were observed:</paragraph>
                              <table width="100%">
                                 <colgroup>
                                    <col width="23.967%" align="left"/>
                                    <col width="34.500%" align="left"/>
                                    <col width="41.533%" align="left"/>
                                 </colgroup>
                                 <tbody>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="middle">
                                          <content styleCode="bold">Adverse Reaction</content>
                                       </td>
                                       <td styleCode="Botrule Rrule Toprule" align="center" valign="top">
                                          <content styleCode="bold">Dogs Treated with Imidacloprid and Moxidectin Only<br/>n = 106</content>
                                       </td>
                                       <td styleCode="Botrule Rrule Toprule" align="center" valign="top">
                                          <content styleCode="bold">Dogs Treated with Imidacloprid and Moxidectin + Melarsomine<br/>n = 108</content>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Cough</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">24 (22.6 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">25 (23.1 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Lethargy</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">14 (13.2 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">42 (38.9 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Vomiting</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">11 (10.4 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">18 (16.7 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Diarrhea, including hemorrhagic</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">10 (9.4 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">22 (20.4 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Inappetence</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">7 (6.6 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">19 (17.6 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Dyspnea</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">6 (5.7 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">10 (9.3 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Tachypnea</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 (&lt; 1 %)</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">7 (6.5 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Pulmonary Hemorrhage</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">0</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">1 (&lt; 1 %)</td>
                                    </tr>
                                    <tr>
                                       <td styleCode="Botrule Lrule Rrule" align="center" valign="top">Death</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">0</td>
                                       <td styleCode="Botrule Rrule" align="center" valign="top">3 (2.8 %)</td>
                                    </tr>
                                 </tbody>
                              </table>
                              <paragraph>Three dogs treated with imidacloprid and moxidectin in a dosing regimen with melarsomine dihydrochloride died of pulmonary embolism from dead and dying heartworms. One dog, treated with imidacloprid and moxidectin and melarsomine dihydrochloride, experienced pulmonary hemorrhage and responded to supportive medical treatment. Following the first treatment with imidacloprid and moxidectin alone, two dogs experienced adverse reactions (coughing, vomiting, and dyspnea) that required hospitalization. In both groups, there were more adverse reactions to imidacloprid and moxidectin following the first treatment than the second treatment.</paragraph>
                              <paragraph>To report a suspected adverse reaction, call Aurora Pharmaceutical at 1-888-215-1256.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                  </section>
               </component>
               <component>
                  <section ID="s16">
                     <id root="d7a4c3d6-6e01-4b97-9492-5a08d29793b7"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Post-Approval Experience
</title>
                     <text>
                        <paragraph>The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events reported in dogs are listed in decreasing order of reporting frequency: depression/lethargy, vomiting, pruritus, diarrhea, anorexia, hyperactivity, ataxia, trembling, hypersalivation, application site reactions (alopecia, pruritus, lesions, and erythema), seizures, and anaphylaxis/anaphylactic reactions (hives, urticaria, facial swelling, edema of the head).</paragraph>
                        <paragraph>
                           <content styleCode="bold">Serious reactions, including neurologic signs and death have been reported when cats have been exposed (orally and topically) to this product.</content>
                        </paragraph>
                        <paragraph>In humans, nausea, numbness or tingling of the mouth/lips and throat, ocular and dermal irritation, pruritus, headache, vomiting, diarrhea, depression and dyspnea have been reported following exposure to this product.</paragraph>
                     </text>
                     <effectiveTime value="20251209"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="L5dc2426e-ab94-4417-8aa4-753163111eaa">
               <id root="fd86823d-f293-412c-aa5f-d7e3d1032485"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Contact Information:</title>
               <text>
                  <paragraph>To report suspected adverse drug experiences and/or obtain a copy of the SDS or for technical assistance, contact Aurora Pharmaceutical at 1-888-215-1256 or www.aurorapharmaceutical.com.</paragraph>
                  <paragraph>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at <content styleCode="underline">http://www.fda.gov/reportamimalae</content>.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s23">
               <id root="d105e42c-9a2a-448e-95e1-80ac03afd5c6"/>
               <code code="34091-9" codeSystem="2.16.840.1.113883.6.1" displayName="ANIMAL PHARMACOLOGY &amp; OR TOXICOLOGY SECTION"/>
               <title>ANIMAL SAFETY:
</title>
               <effectiveTime value="20251209"/>
               <component>
                  <section ID="s24">
                     <id root="ca272883-6b0c-4a1c-b444-16d6faed64d5"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Heartworm-Negative Dogs
</title>
                     <effectiveTime value="20251209"/>
                     <component>
                        <section ID="s25">
                           <id root="a6282417-47a3-4957-98c2-f29e60e0374f"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Field Study:</content> In a controlled, double-masked, field safety study, imidacloprid and moxidectin was administered to 128 dogs of various breeds, 3 months to 15 years of age, weighing 4 to 157 pounds. Imidacloprid and moxidectin was used safely in dogs concomitantly receiving ACE inhibitors, anticonvulsants, antihistamines, antimicrobials, chondroprotectants, corticosteroids, immunotherapeutics, MAO inhibitors, NSAIDs, ophthalmic medications, sympathomimetics, synthetic estrogens, thyroid hormones, and urinary acidifiers. Owners reported the following signs in their dogs after application of imidacloprid and moxidectin<content styleCode="italics">:</content> pruritus, flaky/ greasy residue at the treatment site, medicinal odor, lethargy, inappetence, and hyperactivity.</paragraph>
                              <paragraph>
                                 <content styleCode="bold">(See <linkHtml href="#s10">ADVERSE REACTIONS</linkHtml>.)</content>
                              </paragraph>
                           </text>
                           <effectiveTime value="20241204"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s26">
                           <id root="c78be807-ce9a-49a2-94a5-a03e06d0c6c9"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Safety Study in Puppies: </content>Imidacloprid and moxidectin was applied topically at 1, 3 and 5X the recommended dose to 7-week-old Beagle puppies once every 2 weeks for 6 treatments on days 0, 14, 28, 42, 56, and 70. Loose stools and diarrhea were observed in all groups, including the controls, throughout the study. Vomiting was seen in one puppy from the 1X treatment group (day 57), in two puppies from the 3X treatment group (days 1 and 79), and in one puppy from the 5X treatment group (day 1). Two puppies each in the 1X, 3X, and 5X groups had decreased appetites within 24 hours post-dosing. One puppy in the 1X treatment group had pruritus for one hour following the fifth treatment. A puppy from the 5X treatment group displayed rapid, difficult breathing from 4 to 8 hours following the second treatment.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s27">
                           <id root="5d7709e0-236a-49de-80d1-da104b8b704e"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Dermal Dose Tolerance Study: </content>Imidacloprid and moxidectin was administered topically to 8-month-old Beagle dogs at 10X the recommended dose once. One dog showed signs of treatment site irritation after application. Two dogs vomited, one at 6 hours and one at 6 days post-treatment. Increased RBC, hemoglobin, activated partial thromboplastin, and direct bilirubin were observed in the treated group. Dogs in the treated group did not gain as much weight as the control group.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s28">
                           <id root="5c24f291-7456-4397-850a-d2d6ece0499d"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold"> Oral Safety Study in Beagles:</content> Imidacloprid and moxidectin was administered once orally at the recommended topical dose to 12 dogs. Six dogs vomited within 1 hour of receiving the test article, 2 of these dogs vomited again at 2 hours, and 1 dog vomited again up to 18 hours post-dosing. One dog exhibited shaking (nervousness) 1 hour post-dosing. Another dog exhibited abnormal neurological signs (circling, ataxia, generalized muscle tremors, and dilated pupils with a slow pupillary light response) starting at 4 hours post-dosing through 18 hours postdosing. Without treatment, this dog was neurologically normal at 24 hours and had a normal appetite by 48 hours post-dosing. (See CONTRAINDICATIONS.)</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                  </section>
               </component>
               <component>
                  <section ID="s29">
                     <id root="d35172fe-716b-4aab-b999-05636c703208"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Dermal Safety Study in Ivermectin-Sensitive Collies:
</title>
                     <text>
                        <paragraph>Imidacloprid and moxidectin was administered topically at 3 and 5X the recommended dose every 28 days for 3 treatments to Collies which had been prescreened for avermectin sensitivity. No clinical abnormalities were observed.</paragraph>
                     </text>
                     <effectiveTime value="20251209"/>
                  </section>
               </component>
               <component>
                  <section ID="s30">
                     <id root="7cace1d6-259c-4c8e-a57a-04f28cb0b007"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Oral Safety Study in Ivermectin-Sensitive Collies:
</title>
                     <text>
                        <paragraph>Imidacloprid and moxidectin was administered orally to 5 pre-screened ivermectinsensitive Collies. The Collies were asymptomatic after ingesting 10 % of the minimum labeled dose. At 40 % of the minimum recommended topical dose, 4 of the dogs experienced neurological signs indicative of avermectin toxicity including depression, ataxia, mydriasis, salivation, muscle fasciculation, and coma, and were euthanized.</paragraph>
                        <paragraph>
                           <content styleCode="bold">(See <linkHtml href="#s6">CONTRAINDICATIONS</linkHtml>.)</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20251209"/>
                  </section>
               </component>
               <component>
                  <section ID="s31">
                     <id root="f35a0629-e96d-4641-8e8f-a26beac49417"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Heartworm-Positive Dogs
</title>
                     <effectiveTime value="20251209"/>
                     <component>
                        <section ID="s32">
                           <id root="23fd21cd-97ce-4fe3-a96b-2c4a51261473"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Laboratory Safety Study in Heartworm-Positive Dogs: </content>Imidacloprid and moxidectin was administered topically at 1 and 5X the recommended dose every 14 days for 3 treatments to dogs with adult heartworm infections and circulating microfilaria. At 5X, one dog was observed vomiting three hours after the second treatment. Hypersensitivity reactions were not seen in the 5X treatment group. Microfilaria counts decreased with treatment.</paragraph>
                           </text>
                           <effectiveTime value="20251209"/>
                        </section>
                     </component>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="s33">
               <id root="606d4219-1d78-4930-bb45-624529616caf"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>STORAGE INFORMATION:
</title>
               <text>
                  <paragraph>Store at temperatures between 4°C (39°F) and 25°C (77°F), avoiding excess heat or cold.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="s34">
               <id root="c828b8bc-d568-48e0-8977-98f0f00e9abb"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <title>HOW SUPPLIED:
</title>
               <text>
                  <paragraph>Applications Per Package</paragraph>
                  <paragraph>6 x 0.4 mL tubes</paragraph>
                  <paragraph>6 x 1.0 mL tubes</paragraph>
                  <paragraph>6 x 2.5 mL tubes</paragraph>
                  <paragraph>6 x 4.0 mL tubes</paragraph>
                  <paragraph>6 x 5.0 mL tubes</paragraph>
                  <paragraph>55-1554 06/2025</paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-718</paragraph>
                  <paragraph>MANUFACTURED BY:<br/>
                     <content styleCode="bold">AURORA PHARMACEUTICAL, INC.</content>
                     <br/>
                     <content styleCode="bold">NORTHFIELD, MN 55057</content>
                     <br/>
                     <content styleCode="bold">www.aurorapharmaceutical.com</content>
                  </paragraph>
                  <paragraph>MANUFACTURED IN U.S.A.</paragraph>
                  <paragraph>Barrier is a registered trademark of Aurora Pharmaceutical, Inc.</paragraph>
               </text>
               <effectiveTime value="20251209"/>
            </section>
         </component>
         <component>
            <section ID="La90f80c4-ebf4-42bc-8ef7-3b629f97c838">
               <id root="89772d7b-719d-4dda-b748-00d24ece2a1e"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - 0.4 mL Carton Label</title>
               <text>
                  <paragraph>3 – 9 lbs</paragraph>
                  <paragraph>Heartworm</paragraph>
                  <paragraph>Microfilaria</paragraph>
                  <paragraph>Fleas</paragraph>
                  <paragraph>Hookworm</paragraph>
                  <paragraph>Roundworm</paragraph>
                  <paragraph>Whipworm</paragraph>
                  <paragraph>Sarcoptic<br/>Mange</paragraph>
                  <paragraph>6 Pack</paragraph>
                  <paragraph>Barrier® for dogs<br/>(imidacloprid+moxidectin)<br/>Topical Solution</paragraph>
                  <paragraph>CAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian</paragraph>
                  <paragraph>Once-A-Month Topical Solution</paragraph>
                  <paragraph>Prevention of heartworm disease<br/>Treatment of Dirofilaria immitis circulating microfilariae<br/>Kills adult fleas and is indicated for the treatment of flea infestations<br/>Treatment and control of hookworms, roundworms, and whipworms<br/>Treatment and control of sarcoptic mange<br/>For dogs and puppies 7 weeks of age and older and 3 to 9 lbs.<br/>WARNING</paragraph>
                  <paragraph>DO NOT ADMINISTER THIS PRODUCT ORALLY<br/>For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.<br/>Children should not come in contact with application sites for two (2) hours after application.<br/>(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)</paragraph>
                  <paragraph>Each tube contains 40 mg of imidacloprid and 10 mg of moxidectin.</paragraph>
                  <paragraph>Keep this and all drugs out of the reach of children.</paragraph>
                  <paragraph>Do not use this product on cats.</paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-718</paragraph>
                  <paragraph>SIX 0.4 mL Tubes</paragraph>
                  <paragraph>NDC 51072-100-01</paragraph>
                  <paragraph>IN 40-1545 05/2025</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lcb0ef04f-0c5d-4d85-8fdb-1bb4512d65d0"/>
                  </paragraph>
               </text>
               <effectiveTime value="20251211"/>
               <component>
                  <observationMedia ID="Lcb0ef04f-0c5d-4d85-8fdb-1bb4512d65d0">
                     <text>40-1545 0525</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="40-1545 0525.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L9a9e90e6-802d-4be1-8d28-84f12177d34f">
               <id root="dea21b2e-1926-4e37-8521-ce5bc8569069"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - 1.0 mL Carton Label</title>
               <text>
                  <paragraph>9.1 - 20 lbs.</paragraph>
                  <paragraph>Heartworm</paragraph>
                  <paragraph>Microfilaria</paragraph>
                  <paragraph>Fleas</paragraph>
                  <paragraph>Hookworm</paragraph>
                  <paragraph>Roundworm</paragraph>
                  <paragraph>Whipworm</paragraph>
                  <paragraph>Sarcoptic<br/>Mange</paragraph>
                  <paragraph>6 Pack</paragraph>
                  <paragraph>Barrier® for dogs<br/>(imidacloprid+moxidectin)<br/>Topical Solution</paragraph>
                  <paragraph>CAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian</paragraph>
                  <paragraph>Once-A-Month Topical Solution</paragraph>
                  <paragraph>Prevention of heartworm disease<br/>Treatment of Dirofilaria immitis circulating microfilariae<br/>Kills adult fleas and is indicated for the treatment of flea infestations<br/>Treatment and control of hookworms, roundworms, and whipworms<br/>Treatment and control of sarcoptic mange<br/>For dogs and puppies 7 weeks of age and older and 9.1 to 20 lbs.<br/>WARNING</paragraph>
                  <paragraph>DO NOT ADMINISTER THIS PRODUCT ORALLY<br/>For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.<br/>Children should not come in contact with application sites for two (2) hours after application.<br/>(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)</paragraph>
                  <paragraph>Each tube contains 100 mg of imidacloprid and 25 mg of moxidectin.</paragraph>
                  <paragraph>Keep this and all drugs out of the reach of children.</paragraph>
                  <paragraph>Do not use this product on cats.</paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-718</paragraph>
                  <paragraph>SIX 1.0 mL Tubes</paragraph>
                  <paragraph>NDC 51072-100-02</paragraph>
                  <paragraph>IN 40-1546 05/2025</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Le0deb5d9-410f-4dd2-9f1a-52ef784cb64e"/>
                  </paragraph>
               </text>
               <effectiveTime value="20251211"/>
               <component>
                  <observationMedia ID="Le0deb5d9-410f-4dd2-9f1a-52ef784cb64e">
                     <text>40-1546 0525</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="40-1546 0525.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="Lded1c457-a9c8-4a9a-ac74-2636e09de822">
               <id root="804ce408-c910-4738-a598-4105c294cd50"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - 2.5 mL Carton Label</title>
               <text>
                  <paragraph>20.1 – 55 lbs</paragraph>
                  <paragraph>Heartworm</paragraph>
                  <paragraph>Microfilaria</paragraph>
                  <paragraph>Fleas</paragraph>
                  <paragraph>Hookworm</paragraph>
                  <paragraph>Roundworm</paragraph>
                  <paragraph>Whipworm</paragraph>
                  <paragraph>Sarcoptic<br/>Mange</paragraph>
                  <paragraph>6 Pack</paragraph>
                  <paragraph>Barrier® for dogs<br/>(imidacloprid+moxidectin)<br/>Topical Solution</paragraph>
                  <paragraph>CAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian</paragraph>
                  <paragraph>Once-A-Month Topical Solution</paragraph>
                  <paragraph>Prevention of heartworm disease<br/>Treatment of Dirofilaria immitis circulating microfilariae<br/>Kills adult fleas and is indicated for the treatment of flea infestations<br/>Treatment and control of hookworms, roundworms, and whipworms<br/>Treatment and control of sarcoptic mange<br/>For dogs and puppies 7 weeks of age and older and 20.1 to 55 lbs.<br/>WARNING</paragraph>
                  <paragraph>DO NOT ADMINISTER THIS PRODUCT ORALLY<br/>For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.<br/>Children should not come in contact with application sites for two (2) hours after application.<br/>(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)</paragraph>
                  <paragraph>Each tube contains 250 mg of imidacloprid and 62.5 mg of moxidectin.</paragraph>
                  <paragraph>Keep this and all drugs out of the reach of children.</paragraph>
                  <paragraph>Do not use this product on cats.</paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-718</paragraph>
                  <paragraph>SIX 2.5 mL Tubes</paragraph>
                  <paragraph>NDC 51072-100-03</paragraph>
                  <paragraph>IN 40-1547 05/2025</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lf65939b0-c373-4909-bc47-c45e74021730"/>
                  </paragraph>
               </text>
               <effectiveTime value="20251211"/>
               <component>
                  <observationMedia ID="Lf65939b0-c373-4909-bc47-c45e74021730">
                     <text>40-1547 0525</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="40-1547 0525.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="s44">
               <id root="0d8c4b61-2f52-410b-84fa-76631686626b"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - 4.0 mL Carton Label
</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">55.1 – 88 lbs</content>
                  </paragraph>
                  <paragraph>Heartworm</paragraph>
                  <paragraph>Microfilaria</paragraph>
                  <paragraph>Fleas</paragraph>
                  <paragraph>Hookworm</paragraph>
                  <paragraph>Roundworm</paragraph>
                  <paragraph>Whipworm</paragraph>
                  <paragraph>Sarcoptic<br/>Mange</paragraph>
                  <paragraph>
                     <content styleCode="bold">6 Pack</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Barrier<content>
                           <sup>﻿®</sup>
                        </content> for dogs<br/>(imidacloprid+moxidectin)<br/>Topical Solution</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Once-A-Month Topical Solution</content>
                  </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>Prevention of heartworm disease</item>
                     <item>Treatment of <content styleCode="italics">Dirofilaria immitis</content> circulating microfilariae</item>
                     <item>Kills adult fleas and is indicated for the treatment of flea infestations</item>
                     <item>Treatment and control of hookworms, roundworms, and whipworms</item>
                     <item>Treatment and control of sarcoptic mange</item>
                     <item>For dogs and puppies 7 weeks of age and older and 55.1 to 88 lbs.</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">WARNING</content>
                  </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>
                        <content styleCode="bold">DO NOT ADMINISTER THIS PRODUCT ORALLY</content>
                     </item>
                     <item>
                        <content styleCode="bold">For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.</content>
                     </item>
                     <item>
                        <content styleCode="bold">Children should not come in contact with application sites for two (2) hours after application.</content>
                     </item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)</content>
                  </paragraph>
                  <paragraph>Each tube contains 400 mg of imidacloprid and 100 mg of moxidectin.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Keep this and all drugs out of the reach of children.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Do not use this product on cats.</content>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-718</paragraph>
                  <paragraph>SIX 4.0 mL Tubes</paragraph>
                  <paragraph>NDC 51072-100-04</paragraph>
                  <paragraph>IN 40-1548 05/2025</paragraph>
                  <paragraph/>
                  <paragraph>
                     <renderMultiMedia referencedObject="Ld167925b-23cc-4216-93eb-a4f2a9c7eee2"/>
                  </paragraph>
               </text>
               <effectiveTime value="20251211"/>
               <component>
                  <observationMedia ID="Ld167925b-23cc-4216-93eb-a4f2a9c7eee2">
                     <text>40-1548 0525</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="40-1548 0525.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L8d62b8d0-2723-476b-956f-fae1ac121b21">
               <id root="d679bee1-7308-4c3d-8243-fc51e1389c35"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - 5.0 mL Carton Label</title>
               <text>
                  <paragraph>88.1 – 110 lbs</paragraph>
                  <paragraph>Heartworm</paragraph>
                  <paragraph>Microfilaria</paragraph>
                  <paragraph>Fleas</paragraph>
                  <paragraph>Hookworm</paragraph>
                  <paragraph>Roundworm</paragraph>
                  <paragraph>Whipworm</paragraph>
                  <paragraph>Sarcoptic<br/>Mange</paragraph>
                  <paragraph>6 Pack</paragraph>
                  <paragraph>Barrier® for dogs<br/>(imidacloprid+moxidectin)<br/>Topical Solution</paragraph>
                  <paragraph>CAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian</paragraph>
                  <paragraph>Once-A-Month Topical Solution</paragraph>
                  <paragraph>Prevention of heartworm disease<br/>Treatment of Dirofilaria immitis circulating microfilariae<br/>Kills adult fleas and is indicated for the treatment of flea infestations<br/>Treatment and control of hookworms, roundworms, and whipworms<br/>Treatment and control of sarcoptic mange<br/>For dogs and puppies 7 weeks of age and older and 88.1 to 110 lbs.<br/>WARNING</paragraph>
                  <paragraph>DO NOT ADMINISTER THIS PRODUCT ORALLY<br/>For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.<br/>Children should not come in contact with application sites for two (2) hours after application.<br/>(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information)</paragraph>
                  <paragraph>Each tube contains 500 mg of imidacloprid and 125 mg of moxidectin.</paragraph>
                  <paragraph>Keep this and all drugs out of the reach of children.</paragraph>
                  <paragraph>Do not use this product on cats.</paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-718</paragraph>
                  <paragraph>SIX 5.0 mL Tubes</paragraph>
                  <paragraph>NDC 51072-100-05</paragraph>
                  <paragraph>IN 40-1549 05/2025</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L52d5525a-c41d-48f7-8d7c-85c1ec42e658"/>
                  </paragraph>
               </text>
               <effectiveTime value="20251211"/>
               <component>
                  <observationMedia ID="L52d5525a-c41d-48f7-8d7c-85c1ec42e658">
                     <text>40-1549 0525</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="40-1549 0525.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>