<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="55322498-5fd9-4dbd-90bc-6a6e431ad79d"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>safe-guard<sup>®</sup>
      <br/> (fenbendazole)</title>
   <effectiveTime value="20241115"/>
   <setId root="f5c9ca91-9242-47d6-867a-0f16562b6bee"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="001317601" root="1.3.6.1.4.1.519.1"/>
            <name>Merck Sharp &amp; Dohme Corp.</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section ID="DLDE">
               <id root="e2e7cb66-3aa1-4b6a-8484-b0fe2ed34222"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
               <effectiveTime value="20241115"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="57926-483" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Safe-guard</name>
                        <formCode code="C42938" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="GRANULE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>FENBENDAZOLE</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="222" 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="1" unit="g"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43200" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POUCH"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="3" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="57926-483-01" 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>
                        <asContent>
                           <quantity>
                              <numerator value="2" unit="g"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43200" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POUCH"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="3" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="57926-483-02" 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>
                        <asContent>
                           <quantity>
                              <numerator value="4" unit="g"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43200" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POUCH"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="3" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="57926-483-04" 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="NADA121473" 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="19790105"/>
                           </effectiveTime>
                        </marketingAct>
                     </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="c0d3697c-444f-4909-9ec5-0c3f74805ee6"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Directions:</content> The daily dose for Safe-Guard<sup>®</sup> Canine is 50 mg/kg (22.7 mg/lb) of body weight. You should weigh your dog to make sure you are using the right dose; i.e. correct gram amount and appropriate number of pouches.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Your dog must be treated with the following dose for 3 days in a row.</content>
                  </paragraph>
                  <table width="70%">
                     <col width="45%" align="left" valign="top"/>
                     <col width="55%" align="left" valign="top"/>
                     <thead>
                        <tr>
                           <th styleCode="Lrule">Dog Weight<br/>(lbs)</th>
                           <th styleCode="Rrule">Pouch Size<br/>(Daily Dose)</th>
                        </tr>
                     </thead>
                     <tbody>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">10</td>
                           <td styleCode="Rrule">1 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">11 to 20 </td>
                           <td styleCode="Rrule">2 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">21 to 30<footnote ID="ft1">Combine pouches to obtain recommended daily dosage.</footnote>
                           </td>
                           <td styleCode="Rrule">1 gram + 2 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">31 to 40 </td>
                           <td styleCode="Rrule">4 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">41 to 50<footnoteRef IDREF="ft1"/>
                           </td>
                           <td styleCode="Rrule">1 gram + 4 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">51 to 60<footnoteRef IDREF="ft1"/>
                           </td>
                           <td styleCode="Rrule">2 gram + 4 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">61 to 80<footnoteRef IDREF="ft1"/>
                           </td>
                           <td styleCode="Rrule">Two 4 gram</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">Over 80<footnoteRef IDREF="ft1"/>
                           </td>
                           <td styleCode="Rrule"/>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">Mix daily dose with a small amount of the usual food. Make sure your dog eats all the medicated food. You may need to moisten dry dog food to aid mixing.<br/>
                              <content styleCode="bold">Repeat the dose for 3 days in a row.</content>
                           </td>
                           <td styleCode="Rrule">
                              <paragraph>
                                 <renderMultiMedia referencedObject="MM1"/>
                              </paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20231117"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>Figure</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="safeguard-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="fb118d92-b5e9-4648-8a5a-3891635a95e5"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Recommended Deworming Schedule:</content>
                  </paragraph>
                  <paragraph> Schedule may vary depending on the climate where you live and the activity of your dog. The following schedule should be used as a general guideline.</paragraph>
                  <list listType="unordered" styleCode="Square">
                     <item>Weaned pups (6-8 weeks of age) should be dewormed at 6, 8, 10 and 12 weeks of age.</item>
                     <item>Treat the dam at the same time as the puppies.</item>
                     <item>Dogs over 6 months of age should be dewormed at least twice each year.</item>
                  </list>
               </text>
               <effectiveTime value="20231117"/>
            </section>
         </component>
         <component>
            <section>
               <id root="2e31074c-af00-4c1e-bcf3-e586005d9564"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Diagnosis of Parasites:</content> Consult your veterinarian for help in the diagnosis, treatment and control of parasitism. Specific diagnoses require laboratory testing. Dogs can become infected with several different kinds of tapeworms. Safe-Guard<sup>®</sup> Canine only kills <content styleCode="italics">Taenia</content> species of tapeworms. If you continue to see tapeworm segments in your dog's stool after treatment with Safe-Guard<sup>®</sup> Canine, consult your veterinarian.</paragraph>
                  <paragraph>Roundworms and hookworms may pose serious human health risks; regular deworming may help reduce those risks.</paragraph>
               </text>
               <effectiveTime value="20231117"/>
            </section>
         </component>
         <component>
            <section>
               <id root="e9b6e39b-1a24-481f-bff9-a87435a08ee3"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Product Use:</content> Safe-Guard<sup>®</sup> Canine is safe for use in puppies 6 weeks or older and adult dogs, including pregnant bitches. Do not deworm a dog or puppy that is sick. Consult your veterinarian for diagnosis of the illness.</paragraph>
               </text>
               <effectiveTime value="20231117"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ab49ad4a-44fb-43e3-b4c5-7afddefb1021"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Adverse Reactions:</content> In U.S. clinical studies 3 of 240 dogs (about 1% of the treated dogs) had vomiting associated with the use of the product.</paragraph>
               </text>
               <effectiveTime value="20231117"/>
            </section>
         </component>
         <component>
            <section>
               <id root="dadc8e3e-04b8-469f-83ab-b351e5832ece"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Storage:</content> Store at controlled room temperature 68-77°F (20-25°C).</paragraph>
               </text>
               <effectiveTime value="20231117"/>
            </section>
         </component>
         <component>
            <section>
               <id root="0da0312f-9c46-4f45-8224-b4b12cfffe42"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Questions? Comments?</content>
                  </paragraph>
                  <paragraph>To obtain product information including material safety data sheets (MSDS) or to report a suspected adverse reaction, call <content styleCode="bold">1-800-441-8272.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">MERCK</content>
                     <br/>Animal Health</paragraph>
                  <paragraph>Distributed by:<br/>Intervet Inc (d/b/a Merck Animal Health)<br/>Madison, NJ 07940</paragraph>
                  <paragraph>Rev. 07/22</paragraph>
                  <paragraph>Approved by FDA under NADA # 121-473</paragraph>
                  <paragraph>Fenbendazole (active ingred.) made in: see imprint. Formulated in Austria.</paragraph>
                  <paragraph>
                     <content styleCode="bold">www.Safe-Guard.com</content>
                  </paragraph>
               </text>
               <effectiveTime value="20231117"/>
            </section>
         </component>
         <component>
            <section>
               <id root="d384c9e9-3fad-49a3-b51e-393142d0abee"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 3 Pouch Carton - 10 lbs</title>
               <text>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
                  <paragraph>safe-guard<sup>®</sup>
                     <br/>(fenbendazole)</paragraph>
                  <paragraph>Canine<br/>Dewormer</paragraph>
                  <paragraph>For dogs only, 6 weeks and older.</paragraph>
                  <paragraph>Drug Facts:<br/>Active ingredients (in each dosage unit): Fenbendazole Granules 22.2% (222 mg/g)</paragraph>
                  <paragraph>Uses: For the treatment and control of:</paragraph>
                  <list listType="unordered" styleCode="Square">
                     <item>Tapeworms<br/>(<content styleCode="italics">Taenia pisiformis</content>)</item>
                     <item>Roundworms<br/>(<content styleCode="italics">Toxocara canis, Toxascaris leonina</content>)</item>
                     <item>Hookworms<br/>(<content styleCode="italics">Ancylostoma caninum,<br/>Uncinaria stenocephala</content>)</item>
                     <item>Whipworms<br/>(<content styleCode="italics">Trichuris vulpis</content>)</item>
                  </list>
                  <paragraph>Consult your veterinarian for assistance in the<br/>diagnosis, treatment and control of parasitism.</paragraph>
                  <paragraph>HUMAN WARNING:<br/>KEEP OUT OF REACH OF CHILDREN.</paragraph>
                  <renderMultiMedia referencedObject="MM2"/>
               </text>
               <effectiveTime value="20231117"/>
               <component>
                  <observationMedia ID="MM2">
                     <text>PRINCIPAL DISPLAY PANEL - 3 Pouch Carton - 10 lbs</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="safeguard-02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="8f72e300-c6a0-4a05-a647-07f8716b2970"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 3 Pouch Carton - 20 lbs</title>
               <text>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
                  <paragraph>safe-guard<sup>®</sup>
                     <br/>(fenbendazole)</paragraph>
                  <paragraph>Canine<br/>Dewormer</paragraph>
                  <paragraph>For dogs only, 6 weeks and older.</paragraph>
                  <paragraph>Drug Facts:<br/>Active ingredients (in each dosage unit): Fenbendazole Granules 22.2% (222 mg/g)</paragraph>
                  <paragraph>Uses: For the treatment and control of:</paragraph>
                  <list listType="unordered" styleCode="Square">
                     <item>Tapeworms<br/>(<content styleCode="italics">Taenia pisiformis</content>)</item>
                     <item>Roundworms<br/>(<content styleCode="italics">Toxocara canis, Toxascaris leonina</content>)</item>
                     <item>Hookworms<br/>(<content styleCode="italics">Ancylostoma caninum,<br/>Uncinaria stenocephala</content>)</item>
                     <item>Whipworms<br/>(<content styleCode="italics">Trichuris vulpis</content>)</item>
                  </list>
                  <paragraph>Consult your veterinarian for assistance in the<br/>diagnosis, treatment and control of parasitism.</paragraph>
                  <paragraph>HUMAN WARNING:<br/>KEEP OUT OF REACH OF CHILDREN.</paragraph>
                  <renderMultiMedia referencedObject="MM3"/>
               </text>
               <effectiveTime value="20231117"/>
               <component>
                  <observationMedia ID="MM3">
                     <text>PRINCIPAL DISPLAY PANEL - 3 Pouch Carton - 20 lbs</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="safeguard-03.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="8d669ff9-cc0c-470e-88ea-3bff27d54ddc"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 3 Pouch Carton - 40 lbs</title>
               <text>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
                  <paragraph>safe-guard<sup>®</sup>
                     <br/>(fenbendazole)</paragraph>
                  <paragraph>Canine<br/>Dewormer</paragraph>
                  <paragraph>For dogs only, 6 weeks and older.</paragraph>
                  <paragraph>Drug Facts:<br/>Active ingredients (in each dosage unit): Fenbendazole Granules 22.2% (222 mg/g)</paragraph>
                  <paragraph>Uses: For the treatment and control of:</paragraph>
                  <list listType="unordered" styleCode="Square">
                     <item>Tapeworms<br/>(<content styleCode="italics">Taenia pisiformis</content>)</item>
                     <item>Roundworms<br/>(<content styleCode="italics">Toxocara canis, Toxascaris leonina</content>)</item>
                     <item>Hookworms<br/>(<content styleCode="italics">Ancylostoma caninum,<br/>Uncinaria stenocephala</content>)</item>
                     <item>Whipworms<br/>(<content styleCode="italics">Trichuris vulpis</content>)</item>
                  </list>
                  <paragraph>Consult your veterinarian for assistance in the<br/>diagnosis, treatment and control of parasitism.</paragraph>
                  <paragraph>HUMAN WARNING:<br/>KEEP OUT OF REACH OF CHILDREN.</paragraph>
                  <renderMultiMedia referencedObject="MM4"/>
               </text>
               <effectiveTime value="20231117"/>
               <component>
                  <observationMedia ID="MM4">
                     <text>PRINCIPAL DISPLAY PANEL - 3 Pouch Carton - 40 lbs</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="safeguard-04.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>