<?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="d1630fc8-a50b-4e2f-a257-64546383bdce"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Vetr Primacur (10% fenbendazole oral suspension)</title>
   <effectiveTime value="20260225"/>
   <setId root="7245091c-d91a-465c-a011-6548f666b272"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="132219984" root="1.3.6.1.4.1.519.1"/>
            <name>Vetr LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="132219984" root="1.3.6.1.4.1.519.1"/>
                        <name>Vetr LLC</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="manufacture"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84732" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="label"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="7f397db0-d970-451d-99a9-fcbd3c91d7f7"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20250409"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86213-551" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Primacur</name>
                        <formCode code="C42994" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUSPENSION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>fenbendazole 10% oral</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="100"/>
                              <denominator unit="mL" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FENBENDAZOLE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FENBENDAZOLE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <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="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>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="120"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-551-01" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="240"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-551-02" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="500"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-551-03" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="960"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-551-04" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="1893"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-551-05" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20250409"/>
                           </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"/>
                        </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="L40a7c0b1-62f1-407e-886d-1d45ee13df9b">
               <id root="e96696b7-4c90-4ab1-8f7b-b334d65ab87f"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>Caution</title>
               <text>
                  <paragraph>Shake well before use. Do not give to puppies or kittens under 6 weeks of age. May be administered to pregnant or lactating females.</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L86e37adc-68d5-45b2-9352-d58f8521f609">
               <id root="1095f58d-e050-45d5-98ed-201d84fc503e"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Ingredients</title>
               <text>
                  <paragraph>fenbendazole USP, 100 mg/mL (10% w/v)</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="Lb22a06e3-5da5-4f90-9871-62136a185c8a">
               <id root="6d12e137-793b-4069-bd9f-d045e3d65a06"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Other Ingredients</title>
               <text>
                  <paragraph>Certified vegetable glycerin, natural preservatives and binding agents</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="Le200c4ed-f81d-4e57-b4f3-f18f939a821e">
               <id root="624f1e84-5ca3-448a-b747-b5d2eb8f84e7"/>
               <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 at or below 25 C (&lt;77 F)</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L433eb7b8-9522-4fa0-a000-6c7e6addedb8">
               <id root="238e6efa-8c5d-4031-8809-10e8d3a4e8f2"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <paragraph>Adminster orally once per day for 3 consecutive days. May repeat treatment after 4-6 weeks duration. For animals under 6 months of age, administer 0.25 mL per pound of body weight. For animals over 6 months of age, administer 0.5 mL per pound of body weight.</paragraph>
                  <paragraph>
                     <content styleCode="underline">Dosage Chart (under 6 months age):</content>
                  </paragraph>
                  <paragraph>1 lb body weight   0.25 mL</paragraph>
                  <paragraph>5 lb body weight   1.25 mL</paragraph>
                  <paragraph>10 lb body weight   2.5 mL</paragraph>
                  <paragraph>25 lb body weight   6.25 mL</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="underline">Dosage Chart (over 6 months age):</content>
                  </paragraph>
                  <paragraph>5 lb body weight   2.5 mL</paragraph>
                  <paragraph>10 lb body weight   5 mL</paragraph>
                  <paragraph>20 lb body weight   10 mL</paragraph>
                  <paragraph>40 lb body weight   20 mL</paragraph>
                  <paragraph>50 lb body weight   25 mL</paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L735c19ce-9a13-4983-84c7-e65e199dcaeb">
               <id root="668f66f2-3ad2-485b-b40c-e1d89ffcabfc"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>Say goodbye to worms. Made in the USA. Available in 120mL, 240mL, 500 mL, 960mL and 1/2 Gal (1893mL) sizes.</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="Lb0281755-40d7-41b8-9744-482e9b546e81">
               <id root="65be3992-1999-414d-97b9-12116e4023d8"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L4f66b566-528f-4f39-a8c2-76b9b60cbdf0"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L0a918d03-eeb6-4f19-a01f-d85eae97359a"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="La61975e6-4539-4a0b-ab5e-622475cdd5c5"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2140a15e-4cd4-477b-a6d5-42e837a38db2"/>
                  </paragraph>
               </text>
               <effectiveTime value="20260225"/>
               <component>
                  <observationMedia ID="L4f66b566-528f-4f39-a8c2-76b9b60cbdf0">
                     <text>Primacur White Version 120ml</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Primacur_White Version 120ml.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L0a918d03-eeb6-4f19-a01f-d85eae97359a">
                     <text>Primacur White Version 240ml</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Primacur_White Version 240ml.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="La61975e6-4539-4a0b-ab5e-622475cdd5c5">
                     <text>Primacur White Version 500ml</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Primacur_White Version 500ml.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L2140a15e-4cd4-477b-a6d5-42e837a38db2">
                     <text>Primacur White Version 960ml</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Primacur_White Version 960ml.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>