<?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="6455e369-d21c-435a-b609-50e35df10c23"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Vetr Ivermectin (1.87% ivermectin oral paste)</title>
   <effectiveTime value="20250514"/>
   <setId root="cd88a6b0-34b3-4995-9418-c76f2100a7c5"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="132219984"/>
            <name>Vetr LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="132219984"/>
                        <name>Vetr LLC</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" displayName="manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84732" displayName="label" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="daed2e6d-88a5-4efd-8dd3-43ded35567e0"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20250514"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86213-771" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Ivermectin</name>
                        <formCode code="C42967" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PASTE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Ivermectin oral</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="1VPU26JZZ4" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POTASSIUM SORBATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="A2I8C7HI9T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHYLPARABEN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="Z8IX2SC1OH" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PROPYLPARABEN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="18.7" unit="mg"/>
                              <denominator value="1" unit="g"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="8883YP2R6D" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>IVERMECTIN</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="8883YP2R6D" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>IVERMECTIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="6.1" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-771-01" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43204" displayName="SYRINGE, PLASTIC" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20250507"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <code code="C73627" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="unapproved drug other"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE">
                              <originalText>off white to yellow-white</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C73362" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="APPLE" xsi:type="CE"/>
                        </characteristic>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Oral"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="L051fde32-31a1-4933-a520-2705a54b26d5">
               <id root="94174547-0dcd-490a-88e0-b6e9ec7b1d81"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>Animal Safety</title>
               <text>
                  <paragraph>Not safe or approved for human use. May be used in horses of all ages including mares at any stage of pregnancy. KEEP OUT OF REACH OF CHILDREN.</paragraph>
               </text>
               <effectiveTime value="20250514"/>
            </section>
         </component>
         <component>
            <section ID="L09e3ae2c-dfb6-4619-bebc-19f58ee667e9">
               <id root="4f96c220-fa56-4b4d-af2d-c5a490880b76"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text/>
               <effectiveTime value="20250514"/>
            </section>
         </component>
         <component>
            <section ID="L7d8cea3e-79e7-4d69-a2dc-c8cb69f02abb">
               <id root="91fb6e76-0b4a-4177-a738-4da636aa9ec7"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions for Use</title>
               <text>
                  <paragraph>One syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate (0.2 mg/kg) body weight. Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
                  <paragraph/>
                  <paragraph/>
               </text>
               <effectiveTime value="20250514"/>
            </section>
         </component>
         <component>
            <section ID="Ld8904dbf-199a-474b-9ffb-aaba9da47a3d">
               <id root="7f35027c-6b3b-443e-8015-1ff7c558d50e"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage</title>
               <text>
                  <paragraph>Store at room temperature, 20-25 C (68-77 F)</paragraph>
               </text>
               <effectiveTime value="20250514"/>
            </section>
         </component>
         <component>
            <section ID="L54f6c87e-8a5b-4633-a99e-09820b375f75">
               <id root="c2a35251-dacc-4391-9fb9-6b6a43d52294"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Ingredients</title>
               <text>
                  <paragraph>Ivermectin USP, 18.7 mg/g (1.87% w/w)</paragraph>
               </text>
               <effectiveTime value="20250514"/>
            </section>
         </component>
         <component>
            <section ID="L349143c8-114f-4b31-9ff9-d07acca128a1">
               <id root="0b1a380d-eac9-4ba4-bf04-b81671f21df5"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Other Ingredients</title>
               <text>
                  <paragraph>Certified vegetable glycerine, natural preservative, stabilizers and flavoring </paragraph>
               </text>
               <effectiveTime value="20250514"/>
            </section>
         </component>
         <component>
            <section ID="L5788609e-8dd3-4b30-a0dc-2dbd39ed92fe">
               <id root="68f00a2b-972e-4f3a-9ddc-d4260810925e"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L249a59eb-0451-4269-a466-bc67e7e1c399"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250514"/>
               <component>
                  <observationMedia ID="L249a59eb-0451-4269-a466-bc67e7e1c399">
                     <text>ivermectin-paste-label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="ivermectin-paste-label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>