<?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="44c9f432-11e3-4fec-90c9-b59805e9d9e6"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Ozipco<sup>®</sup>
      <br/> (fenbendazole)</title>
   <effectiveTime value="20260331"/>
   <setId root="62fe5085-1b3f-4e69-9ed5-2a89c60cce83"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="123898597" root="1.3.6.1.4.1.519.1"/>
            <name>Fast Sold LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <id root="1.3.6.1.4.1.519.1" extension="123898597"/>
                  <name>Fast Sold LLC</name>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="654211754"/>
                        <name>Zhejiang Hisun Pharmaceutical Co., Ltd.</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" displayName="api manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section ID="DLDE">
               <id root="f637b5c8-6fd6-4b1b-a892-6e7cc3d84cd9"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
               <effectiveTime value="20260331"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86241-101" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Ozipco</name>
                        <formCode code="C42967" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PASTE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Fenbendazole</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="100" unit="mg"/>
                              <denominator value="1" unit="g"/>
                           </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>
                        <asContent>
                           <quantity>
                              <numerator value="25" unit="g"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43204" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SYRINGE, PLASTIC"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="86241-101-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA120648" root="2.16.840.1.113883.3.150"/>
                           <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20200515"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <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>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C73377" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CINNAMON" 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 root="fba59cfe-ed57-455f-b371-95566ab5e517"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Paste 10% (100 mg/g)<br/>
                     <content styleCode="bold">HORSE DEWORMER</content>
                  </paragraph>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="2647fbb6-f10e-4591-ae3c-6d9d1be7e2b3"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION:</title>
               <text>
                  <paragraph>Ozipco<sup>®</sup> (fenbendazole) Paste 10% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenyl-thio)-2-benzimidazole carbamate.</paragraph>
                  <paragraph>The CAS Registry Number is 43210-67-9.</paragraph>
                  <paragraph>The chemical structure is:</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="MM1"/>
                  </paragraph>
                  <paragraph>Each gram of Ozipco<sup>®</sup> Paste 10% contains 100 mg of fenbendazole and is flavored with artificial apple-cinnamon liquid.</paragraph>
               </text>
               <effectiveTime value="20260331"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>Chemical Structure</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="ozipco-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="6936e7dc-d08c-4e95-9eaa-d44a4088fd80"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>ACTIONS:</title>
               <text>
                  <paragraph>The antiparasitic action of Ozipco<sup>®</sup> Paste 10% is believed to be due to the inhibition of energy metabolism in the parasite.</paragraph>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="c81e4703-1fc6-40de-b8c2-e4b74c5f82d5"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS:</title>
               <effectiveTime value="20260331"/>
               <component>
                  <section>
                     <id root="02912877-6249-4b46-9257-6b6a72fbbbb5"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Horses:</content> Ozipco Paste 10% is indicated for the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), encysted early 3rd stage (hypobiotic), late 3rd stage and 4th stage cyathostome larvae, small strongyles, pinworms (Oxyuris equi), ascarids (Parascaris equorum), and for the control of arteritis caused by 4th stage larvae of Strongylus vulgaris in horses.</paragraph>
                     </text>
                     <effectiveTime value="20260331"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="503f1578-293a-4f64-9ea0-0e6c30c539d8"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS:</title>
               <effectiveTime value="20260331"/>
               <component>
                  <section>
                     <id root="1175b38a-726a-45f9-94b6-db4da34700fa"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Horses:</content> Side effects associated with Ozipco Paste 10% could not be established in well-controlled safety studies in horses using single doses as high as 45 mg/lb (100 mg/kg) and 5 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly with higher doses, the release of antigen following parasite death may result in either a local or systemic hypersensitivity reaction. As with any drug, these reactions should be treated symptomatically. Ozipco Paste 10% has been evaluated for safety in pregnant mares during all stages of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in stallions with doses as high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproduction were detected. The recommended dose for control of 4th stage Strongylus vulgaris larvae, 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days, has not been evaluated for safety in stallions or pregnant mares.</paragraph>
                     </text>
                     <effectiveTime value="20260331"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="23903783-25f4-45f7-a780-9609a4a0dcfb"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE:</title>
               <text>
                  <paragraph>For foals and weanlings (less than 18 months of age) where ascarids are a common problem, the recommended dose is 4.6 mg/lb (10 mg/kg); one syringe will deworm a 550 lb horse. For the control of large strongyles, small strongyles, and pinworms, the recommended dose is 2.3 mg/lb (5 mg/kg). For control of hypobiotic (encysted early 3rd stage), late 3rd stage, and 4th stage cyathostomum larvae, 5 day treatment is recommended (10 mg/kg daily for 5 consecutive days); administer one syringe for each 550 lb body weight per day. Do not underdose. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="4901a064-330f-40fb-b88d-3b9bbef17287"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content> NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-929-822-0639. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or <content styleCode="underline">http://www.fda.gov/reportanimalae.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="d5bcea83-8bfd-4819-b078-29ca290e8223"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">OTHER WARNINGS:</content> Do not use in horses intended for human consumption. Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with pasture management practices appropriate to the geographic area and animals on the premises may reduce the potential for parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="e1d56795-a157-4615-a70f-5c501215114b"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS FOR USE:</title>
               <text>
                  <list listType="ordered" styleCode="Arabic">
                     <item>Determine the weight of the horse.</item>
                     <item>Remove syringe tip.</item>
                     <item>Turn the dial ring until the edge of the ring nearest the tip lines up with the correct weight marking.</item>
                     <item>Depress plunger to advance paste to tip.</item>
                     <item>Set the dial ring at the graduation nearest the weight of the horse for the dosage rate of 5 mg/kg. For the dosage rate of 10 mg/kg, set the dial ring at two times (double) the horse’s weight.</item>
                     <item>
                        <table width="90%">
                           <colgroup>
                              <col width="32%" align="left" valign="top"/>
                              <col width="34%" align="left" valign="top"/>
                              <col width="34%" align="left" valign="top"/>
                           </colgroup>
                           <thead>
                              <tr styleCode="First Last">
                                 <th styleCode="Lrule Rrule" align="left">Body Weight</th>
                                 <th styleCode="Rrule" align="left">Number of marks for 2.3 mg/lb (5 mg/kg) dose for cattle or horses</th>
                                 <th styleCode="Rrule" align="left">Number of marks for 4.6 mg/lb (10 mg/kg) dose for horses only</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule First">
                                 <td styleCode="Lrule Rrule" align="left">250 lb</td>
                                 <td styleCode="Rrule" align="left">1</td>
                                 <td styleCode="Rrule" align="left">2</td>
                              </tr>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule" align="left">500 lb</td>
                                 <td styleCode="Rrule" align="left">2</td>
                                 <td styleCode="Rrule" align="left">4</td>
                              </tr>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule" align="left">750 lb</td>
                                 <td styleCode="Rrule" align="left">3</td>
                                 <td styleCode="Rrule" align="left">6</td>
                              </tr>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule" align="left">1000 lb</td>
                                 <td styleCode="Rrule" align="left">4</td>
                                 <td styleCode="Rrule" align="left">8</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule" align="left">1500 lb</td>
                                 <td styleCode="Rrule" align="left">6</td>
                                 <td styleCode="Rrule" align="left">12</td>
                              </tr>
                           </tbody>
                        </table>
                     </item>
                     <item>Horse’s mouth should be free of food.</item>
                     <item>Insert nozzle of syringe through the interdental space and deposit the paste on the back of the tongue by depressing the plunger.</item>
                  </list>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="1774cbd5-694e-4357-b8cf-9d6dfb0fcdfe"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <title>HOW SUPPLIED:</title>
               <text>
                  <paragraph>Ozipco<sup>®</sup> Paste 10% Horse Dewormer is supplied in 25 gram syringes.</paragraph>
               </text>
               <effectiveTime value="20260331"/>
               <component>
                  <section>
                     <id root="7220988f-9ed1-4ca8-88db-f72c56c0b6ba"/>
                     <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
                     <text>
                        <paragraph>Store at or below 25°C (77°F).</paragraph>
                        <paragraph>Use Only as Directed<br/>Fenbendazole (active ingredient) made in: see imprint. Formulated in France.</paragraph>
                        <paragraph>CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT AND CONTROL OF PARASITISM.</paragraph>
                     </text>
                     <effectiveTime value="20260331"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="a3a1aea0-c115-4c92-9284-f338e22b789d"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Distributed by:<br/>Fast sold llc<br/>avocado ave unit 5, melbourne Florida 32935<br/>support@ozipco.us<br/>www.fastsoldllc.com</paragraph>
               </text>
               <effectiveTime value="20260331"/>
            </section>
         </component>
         <component>
            <section>
               <id root="900c25d6-f73c-4223-bbb0-91c1ac9427a2"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>FENBENDAZOLE</paragraph>
                  <paragraph>Equine Dewormer Paste</paragraph>
                  <paragraph>Safe &amp; Effective Formula • Veterinary Strength<br/>25 gram paste 10% (100mg/g</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2c55d6be-8aab-4eaa-9dab-7842cf2296e0"/>
                  </paragraph>
               </text>
               <effectiveTime value="20260331"/>
               <component>
                  <observationMedia ID="L2c55d6be-8aab-4eaa-9dab-7842cf2296e0">
                     <text>product label01</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="packet-final-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>