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   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Safe-guard<sup>®</sup>
      <br/> (fenbendazole)<br/> Dewormer<br/> 20% Type A Medicated Article</title>
   <effectiveTime value="20241119"/>
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   <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>
                  <id extension="834721284" root="1.3.6.1.4.1.519.1"/>
                  <name>ADM Alliance Nutrition, Inc.</name>
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               <effectiveTime value="20241119"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="57926-090" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Safe-Guard</name>
                        <formCode code="C42972" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Fenbendazole</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="200" unit="g"/>
                              <denominator value="1" unit="kg"/>
                           </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="11.34" unit="kg"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43167" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BAG"/>
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                                    <code code="57926-090-25" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43167" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BAG"/>
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                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
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                           <statusCode code="active"/>
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                              <low value="19840131"/>
                           </effectiveTime>
                        </marketingAct>
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                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CATTLE: Dairy and Beef Cattle</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">SWINE: Growing pigs, gilts, pregnant sows and boars</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">HORSES</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Zoo and Wildlife Animals</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Growing Turkeys</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Wild Quail</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">MUST BE MIXED BEFORE FEEDING ACCORDING TO DIRECTIONS AND PERMITTED CLAIMS.<br/>FOR USE IN MANUFACTURED FEEDS ONLY.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
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         <component>
            <section>
               <id root="b821c9a5-4b54-4f78-acbe-bb22beaec3cf"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">ACTIVE DRUG INGREDIENT: Fenbendazole 200 grams per kilogram (90.7 grams per pound).</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">INERT INGREDIENTS: Roughage Products or Roughage Products and Calcium Carbonate; and Mineral Oil.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a5fb18bf-faa7-4661-80dd-7e18a2beb946"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CATTLE: Dairy and Beef Cattle</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR THE TREATMENT AND CONTROL OF:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Lungworms: </content>Adult <content styleCode="italics">Dictyocaulus viviparus</content>; <content styleCode="bold">Stomach worms: </content>Adult brown stomach worms (<content styleCode="italics">Ostertagia ostertagi</content>), Adult and fourth stage larvae barberpole worms (<content styleCode="italics">Haemonchus contortus</content>), fourth stage larvae barberpole worms (<content styleCode="italics">H. placei</content>), and Adult and fourth stage larvae small stomach worms (<content styleCode="italics">Trichostrongylus axei</content>); <content styleCode="bold">Intestinal worms </content>(Adult and fourth stage larvae): hookworms (<content styleCode="italics">Bunostomum phlebotomum</content>), thread-necked intestinal worms (<content styleCode="italics">Nematodirus helvetianus</content>), small intestinal worms (<content styleCode="italics">Cooperia punctata &amp; C. oncophora</content>), bankrupt worms (<content styleCode="italics">Trichostrongylus colubriformis</content>), and nodular worms (<content styleCode="italics">Oesophagostomum radiatum</content>).</paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
         </component>
         <component>
            <section>
               <id root="f5fdc77f-04fb-4627-b4e8-50cb5fc30d6a"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DRUG FEEDING RATE:</title>
               <text>
                  <paragraph>5 mg fenbendazole per kg body weight in a one (1) day treatment (2.27 mg fenbendazole per pound).</paragraph>
                  <paragraph>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>
               </text>
               <effectiveTime value="20241119"/>
               <component>
                  <section>
                     <id root="70c0356d-f86a-42bf-a50c-f4e6358b053a"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>MIXING DIRECTIONS:</title>
                     <text>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated cattle feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Cattle Type B Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="middle"/>
                           <col width="50%" align="center" valign="middle"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">11.04</td>
                                 <td styleCode="Rrule">1,001 (0.5)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">195.59</td>
                                 <td styleCode="Rrule">17,740 (8.9)</td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated cattle feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.</paragraph>
                        <paragraph>The following table gives examples of how some complete Type C medicated feeds can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Cattle Type C Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="middle"/>
                           <col width="50%" align="center" valign="middle"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">2.20</td>
                                 <td styleCode="Rrule">200 (0.1)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">11.02</td>
                                 <td styleCode="Rrule">1,000 (0.5)</td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
                     <effectiveTime value="20241119"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="fc06e2a4-f3d0-402e-b5d3-aab7b99d77f5"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>FEEDING DIRECTIONS:</title>
                     <text>
                        <paragraph>Feed as the sole ration for one (1) day. No prior withdrawal of feed or water necessary. Type C medicated cattle feeds containing SAFE-GUARD<sup>®</sup> 20% can be fed pelleted or as a meal.</paragraph>
                        <paragraph>FREE-CHOICE FEEDS: Type C free-choice medicated feed must be manufactured by a licensed feed mill according to an approved formula to provide a total of 5 mg per kg body weight fenbendazole over 3 to 6 days.</paragraph>
                     </text>
                     <effectiveTime value="20241119"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="d022f016-1dbf-4e22-871d-d35d7ebd13bc"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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 1-800-211-3573. 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="20241119"/>
               <component>
                  <section>
                     <id root="ed46eb3c-2817-4dcd-9ecd-edd02c196806"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of 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 the 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 a 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="20241119"/>
                     <component>
                        <section>
                           <id root="9b63cd8d-89c1-4700-a3e8-58be6dfb3436"/>
                           <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="italics bold">Withdrawal Periods and Residue Warnings:</content> Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.</paragraph>
                           </text>
                           <effectiveTime value="20241119"/>
                        </section>
                     </component>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="740f1161-5c7c-440b-8fa7-74be4193689f"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">SWINE: Growing pigs, gilts, pregnant sows, and boars</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR THE TREATMENT AND CONTROL OF:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Lungworms:</content> Adult<content styleCode="italics"> Metastrongylus apri,</content> adult <content styleCode="italics">Metastrongylus pudendotectus</content>; <content styleCode="bold">Gastrointestinal worms:</content> Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (<content styleCode="italics">Ascaris suum</content>), Adult nodular worms (<content styleCode="italics">Oesophagostomum dentatum, O. quadrispinulatum</content>), Adult small stomach worms (<content styleCode="italics">Hyostrongylus rubidus</content>), Adult and larvae (L2, L3, L4 stages - intestinal mucosal forms), whipworms (<content styleCode="italics">Trichuris suis</content>); and <content styleCode="bold">Kidney worms:</content> Adult and larvae<content styleCode="italics"> Stephanurus dentatus</content>. 						</paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
         </component>
         <component>
            <section>
               <id root="4eaa82c5-2b00-4874-b37f-ec1a11f87202"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DRUG FEEDING RATE:</title>
               <text>
                  <paragraph>9 mg fenbendazole per kg body weight (4.08 mg fenbendazole per pound) to be fed as the sole ration over a period of 3 to 12 days.</paragraph>
               </text>
               <effectiveTime value="20241119"/>
               <component>
                  <section>
                     <id root="274b8ac6-c453-4c7c-bab1-2aaf6da55993"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>MIXING DIRECTIONS:</title>
                     <text>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Swine Type B Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="middle"/>
                           <col width="50%" align="center" valign="middle"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">11.03</td>
                                 <td styleCode="Rrule">1,000 (0.5)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">195.59</td>
                                 <td styleCode="Rrule">17,740 (8.9)</td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.</paragraph>
                        <paragraph>The following table gives examples of how some complete Type C medicated feeds can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Swine Type C Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="middle"/>
                           <col width="50%" align="center" valign="middle"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">0.11</td>
                                 <td styleCode="Rrule">10 (0.005)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">3.31</td>
                                 <td styleCode="Rrule">300 (0.15)</td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
                     <effectiveTime value="20241119"/>
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                  <section>
                     <id root="37d45eed-c4ff-48a4-82df-02ed24d7d5bc"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>FEEDING DIRECTIONS:</title>
                     <text>
                        <paragraph>Feed as the sole ration for three (3) to twelve (12) consecutive days. No prior withdrawal of feed or water necessary.</paragraph>
                        <paragraph>Type C medicated swine feeds containing SAFE-GUARD<sup>®</sup> 20% can be fed pelleted or as a meal.</paragraph>
                     </text>
                     <effectiveTime value="20241119"/>
                  </section>
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         <component>
            <section>
               <id root="deb221cf-adf1-4c5a-8196-b51adcc9d79b"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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 1-800-211-3573. 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="20241119"/>
               <component>
                  <section>
                     <id root="069c131c-5c53-4d46-a933-bf3d59ac85ca"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
                     </text>
                     <effectiveTime value="20241119"/>
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                           <id root="33a66e89-1446-45cf-9f54-473d5f3ba6f5"/>
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                           <text>
                              <paragraph>
                                 <content styleCode="bold italics">Withdrawal Periods</content>
                                 <content styleCode="bold">:</content> Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product.</paragraph>
                           </text>
                           <effectiveTime value="20241119"/>
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            </section>
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               <id root="9531fe9e-263c-47c0-ae71-110f78a7cf5a"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>HORSES</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR THE TREATMENT AND CONTROL OF:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Large strongyles</content> (<content styleCode="italics">Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus</content> spp.),  <content styleCode="bold">Small strongyles</content> (<content styleCode="italics">Cyathostomum</content> spp., <content styleCode="italics">Cylicocyclus spp., Cylicostephanus spp.),</content>
                     <content styleCode="bold"> Pinworms </content>
                     <content styleCode="italics">(Oxyuris equi),</content>
                     <content styleCode="bold italics">  Ascarids </content>
                     <content styleCode="italics">(Parascaris equorum).</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241119"/>
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         </component>
         <component>
            <section>
               <id root="46eab262-6199-4e1f-a549-a10a52b55697"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DRUG FEEDING RATE:</title>
               <text>
                  <paragraph>For the control of large strongyles, small strongyles, and pinworms the recommended dose is 5 mg fenbendazole per kg body weight (2.27 mg fenbendazole per pound) in a one (1) day treatment. For the control of ascarids the recommended dose is 10 mg fenbendazole per kg body weight (4.54 mg fenbendazole per pound) in a one (1) day treatment.</paragraph>
                  <paragraph>All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed.</paragraph>
                  <paragraph>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>
               </text>
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                     <title>MIXING DIRECTIONS:</title>
                     <text>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated horse feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Equine Type B Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">110.25</td>
                                 <td styleCode="Rrule">10,000 (5.0)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">195.59</td>
                                 <td styleCode="Rrule">17,740 (8.9)</td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> Type A medicated article with equine feed according to the table below to obtain the proper concentration in the Type C medicated feed.</paragraph>
                        <table width="85%">
                           <caption>Equine Type C Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td styleCode="Lrule Rrule">50.05</td>
                                 <td styleCode="Rrule">4,540 (2.27)</td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
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                     <title>FEEDING DIRECTIONS:</title>
                     <text>
                        <paragraph>No prior withdrawal of feed or water necessary. Type C medicated horse feed containing SAFE-GUARD<sup>®</sup> 20% can also be fed pelleted.</paragraph>
                     </text>
                     <effectiveTime value="20241119"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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 1-800-211-3573. 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>
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                     <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of 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 the 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 a 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>
                        <paragraph>Do not use in horses intended for human consumption.</paragraph>
                     </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Approved by FDA under NADA # 131-675</paragraph>
                  <paragraph>CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT, AND CONTROL OF PARASITISM.</paragraph>
               </text>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">SEE OTHER SIDE FOR ZOO AND WILDLIFE ANIMALS, GROWING TURKEYS AND WILD QUAIL.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Weight 25 pounds (11.34 kg)</content>
                  </paragraph>
                  <paragraph>Lot/Expiration date located below:</paragraph>
                  <paragraph>797217 R2</paragraph>
               </text>
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               <id root="1e586ef0-1ea2-4432-a652-2c3400aed1e1"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>Zoo and Wildlife Animals</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR THE TREATMENT AND CONTROL OF:</content>
                  </paragraph>
                  <paragraph>Internal parasites in hoofed zoo and wildlife animals (see dosage section for specific parasites, animal species and required doses).</paragraph>
               </text>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DRUG FEEDING RATES:</title>
               <text>
                  <table width="85%">
                     <col width="27%" align="left" valign="top"/>
                     <col width="40%" align="center" valign="top"/>
                     <col width="33%" align="center" valign="top"/>
                     <thead>
                        <tr>
                           <th styleCode="Lrule Rrule">Host Animal</th>
                           <th styleCode="Rrule">Recommended Treatment For</th>
                           <th styleCode="Rrule">mg Fenbendazole/kg<br/>Body Wt./Day<br/>× Days of Treatment</th>
                        </tr>
                     </thead>
                     <tbody>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule">Bighorn sheep (<content styleCode="italics">Ovis canadensis canadensis</content>)</td>
                           <td styleCode="Rrule">
                              <content styleCode="bold">Lungworms:</content> (<content styleCode="italics">Protostrongylus</content> spp.)</td>
                           <td styleCode="Rrule">10 mg/kg/day × 3 days</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule">Feral swine<br/>(<content styleCode="italics">Sus scrofa</content>)</td>
                           <td styleCode="Rrule">
                              <content styleCode="bold">Kidney worms:</content> (<content styleCode="italics">Stephanurus dentatus</content>),<br/>
                              <content styleCode="bold">Roundworms:</content>(<content styleCode="italics">Ascaris suum</content>),<br/>
                              <content styleCode="bold">Nodular worms: </content>(<content styleCode="italics">Oesophagostomum dentatum</content>)</td>
                           <td styleCode="Rrule">3 mg/kg/day × 3 days</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule Botrule" rowspan="2">
                              <content styleCode="bold">Ruminants – subfamily<br/>antilopinae:</content>
                              <br/>Persian gazelles<br/>(<content styleCode="italics">Gazella subgutturosa<br/>subgutturosa</content>)<br/>Addra gazelle<br/>(<content styleCode="italics">Gazella dama ruficollis</content>)<br/>Slendorhorn gazelle<br/>(<content styleCode="italics">Gazella leptoceros</content>)<br/>Kenya impala<br/>(<content styleCode="italics">Aepyceros melampus rendilis</content>)<br/>Roosevelt's gazelle<br/>(<content styleCode="italics">Gazella granti roosevelti</content>)<br/>Indian blackbuck<br/>(<content styleCode="italics">Antilope cervicapra</content>)<br/>Mhorr gazelle (<content styleCode="italics">Gazella dama mhorr</content>)<br/>Thomson's gazelles<br/>(<content styleCode="italics">Gazella thomsoni thomsoni</content>)<br/>
                              <content styleCode="bold">Ruminants – subfamily<br/>hippotraginae:</content>
                              <br/>Addax<br/> (<content styleCode="italics">Addax nasomaculatus</content>)<br/>Angolan roan antelope<br/>(<content styleCode="italics">Hippotragus equinus cottoni</content>)<br/>Fringed-ear oryx<br/> (<content styleCode="italics">Oryx gazelle callotis</content>)<br/>Arabian oryx<br/> (<content styleCode="italics">Oryx leucoryx</content>)<br/>
                              <content styleCode="bold">Ruminants – subfamily<br/>caprinae:</content>
                              <br/>Armenian mouflon<br/> (<content styleCode="italics">Ovis orientalis gmelini</content>)<br/>Russian saiga<br/> (<content styleCode="italics">Saiga tatarica</content>)</td>
                           <td styleCode="Rrule" align="left">
                              <br/>
                              <content styleCode="bold">Small stomach worms:</content>
                              <br/>(<content styleCode="italics">Trichostrongylus</content> spp.),<br/>
                              <content styleCode="bold">Thread-necked intestinal worms:</content>
                              <br/>(<content styleCode="italics">Nematodirus</content> spp.),<br/>
                              <content styleCode="bold">Barberpole worms:</content>
                              <br/>(<content styleCode="italics">Haemonchus</content> spp.),<br/>
                              <content styleCode="bold">Whipworms:</content>
                              <br/>(<content styleCode="italics">Trichuris</content> spp.)</td>
                           <td styleCode="Rrule Botrule" rowspan="2">
                              <br/>
                              <br/>2.5 mg/kg/day × 3 days<br/>
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                           <td styleCode="Lrule Rrule" valign="bottom" align="center">
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                           </td>
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                  </table>
                  <paragraph>It is recommended that the user exercise judgmental expertise as needed for retreatment within six (6) weeks. This would depend upon the conditions of continued exposure to parasites, condition of treated animals, and ambient temperatures.</paragraph>
               </text>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>MIXING DIRECTIONS:</title>
                     <text>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated zoo/wildlife animal feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.</paragraph>
                        <paragraph>The following table gives examples of how some complete Type C medicated feeds can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Feral Swine, Wildlife and Zoo Ruminants &amp; Bighorn Sheep Type C Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type C Medicated Feed<br/>[grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">0.55</td>
                                 <td styleCode="Rrule">50 (0.025)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">11.02</td>
                                 <td styleCode="Rrule">1,000 (0.5)</td>
                              </tr>
                           </tbody>
                        </table>
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               <title>FEEDING DIRECTIONS:</title>
               <text>
                  <paragraph>Type C medicated feeds containing SAFE-GUARD<sup>®</sup> 20% can be fed in either a mash or pelleted form. No prior withdrawal of feed or water is necessary.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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 1-800-211-3573. 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>
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               <text>
                  <paragraph>
                     <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
               </text>
               <effectiveTime value="20241119"/>
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               <id root="6c04d8a9-5edc-47bf-af37-f5f1066fe27a"/>
               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNING:</content> Do not use 14 days before or during the hunting season.</paragraph>
               </text>
               <effectiveTime value="20241119"/>
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               <id root="a9e1ccae-22df-43c2-bc81-88ac0e8f7d8c"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>Growing Turkeys</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR THE TREATMENT AND CONTROL OF:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Gastrointestinal worms: </content>Roundworms, Adults and larvae (<content styleCode="italics">Ascaridia dissimilis</content>); Cecal worms, Adults and larvae (<content styleCode="italics">Heterakis gallinarum</content>), an important vector of<content styleCode="italics"> Histomonas meleagridis </content>(Blackhead). 						</paragraph>
               </text>
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               <id root="e139ab5e-6bd8-4b58-be26-05fb3a712da8"/>
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               <title>DRUG FEEDING RATE:</title>
               <text>
                  <paragraph>14.5 g fenbendazole/ton of feed, to be fed as the sole ration for 6 days.</paragraph>
               </text>
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                     <id root="341005bf-2d34-457a-91b2-f078a1993bdb"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>MIXING DIRECTIONS:</title>
                     <text>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated turkey feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives an example of how some Type B medicated feed concentrations can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Turkey Type B Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">5.51</td>
                                 <td styleCode="Rrule">500 (0.25)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">195.59</td>
                                 <td styleCode="Rrule">17,740 (8.9)</td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated growing turkey feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.</paragraph>
                        <paragraph>The following table describes how to obtain the proper concentration in the complete Type C medicated feed:</paragraph>
                        <table width="85%">
                           <caption>Turkey Type C Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td styleCode="Lrule Rrule">0.16</td>
                                 <td styleCode="Rrule">14.5 (0.007)</td>
                              </tr>
                           </tbody>
                        </table>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>FEEDING DIRECTIONS:</title>
                     <text>
                        <paragraph>Medicated feed containing fenbendazole should be fed as the sole ration for six (6) consecutive days to growing turkeys only. No prior withdrawal of feed or water necessary. Type C medicated growing turkey feeds containing SAFE-GUARD<sup>®</sup> 20% can be fed pelleted or as a meal.</paragraph>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.</paragraph>
               </text>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
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                           <text>
                              <paragraph>
                                 <content styleCode="italics bold">Withdrawal Periods:</content> No withdrawal period is required when used according to labeling.</paragraph>
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               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>Wild Quail</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR THE TREATMENT AND CONTROL OF:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Gastrointestinal worms: </content>Cecal worms, (<content styleCode="italics">Aulonocephalus</content> spp.)</paragraph>
               </text>
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            </section>
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            <section>
               <id root="d30801e7-aaa8-4113-808c-712ab0e8c78f"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DRUG FEEDING RATE:</title>
               <text>
                  <paragraph>90.7 g fenbendazole/ton of feed, to be fed for 21 days.</paragraph>
               </text>
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                     <id root="c7ec9d60-ab39-4dc0-842d-c2fc35e5043e"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>MIXING DIRECTIONS:</title>
                     <text>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated Wild Quail feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives an example of how some Type B medications can be prepared:</paragraph>
                        <table width="85%">
                           <caption>Wild Quail Type B Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr styleCode="Botrule">
                                 <td styleCode="Lrule Rrule">11.04</td>
                                 <td styleCode="Rrule">1,001 (0.50)</td>
                              </tr>
                              <tr>
                                 <td styleCode="Lrule Rrule">195.59</td>
                                 <td styleCode="Rrule">17,740 (8.9)</td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>Thoroughly mix SAFE-GUARD<sup>®</sup> 20% Type A medicated article with non-medicated Wild Quail feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.</paragraph>
                        <paragraph>The following table describes how to obtain the proper concentration in the complete Type C medicated feed:</paragraph>
                        <table width="85%">
                           <caption>Wild Quail Type C Medicated Feed Instructions</caption>
                           <col width="50%" align="center" valign="top"/>
                           <col width="50%" align="center" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="Lrule Rrule">Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed</th>
                                 <th styleCode="Rrule">Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td styleCode="Lrule Rrule">1.0</td>
                                 <td styleCode="Rrule">90.7 (0.05)</td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>FEEDING DIRECTIONS:</title>
                     <text>
                        <paragraph>Medicated feed should be fed for 21 consecutive days to wild quail. No prior withdrawal of feed is necessary. It is recommended that wild quail feed containing SAFE-GUARD<sup>®</sup> be fed as crumbles. It is not recommended that medicated feed containing fenbendazole be generally broadcast, but rather offered in strategic feeding stations or through feeders. Users should ensure that the medicated feed is consistently available during the 21-day treatment period.</paragraph>
                     </text>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.</paragraph>
               </text>
               <effectiveTime value="20241119"/>
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                  <section>
                     <id root="103e335c-4a7e-487e-b451-874eadee8225"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
                     </text>
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                        <section>
                           <id root="2a895843-f030-4038-836d-dfc769ded9fc"/>
                           <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="italics bold">Withdrawal Periods:</content> No withdrawal period is required when used according to labeling.</paragraph>
                           </text>
                           <effectiveTime value="20241119"/>
                        </section>
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                  </section>
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            </section>
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               <id root="f92beaae-5d12-4e47-87bd-cf63702f12c7"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS TREATMENT AND CONTROL OF PARASITISM.</paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
         </component>
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            <section>
               <id root="4da314a9-a521-4c62-abb3-2a0aaa6c1469"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241119"/>
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               <id root="9cfd0f21-4f15-48ee-afe2-3c291672417d"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">SEE OTHER SIDE FOR CATTLE, SWINE, AND HORSES.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Weight 25 pounds (11.34 kg)</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
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         <component>
            <section>
               <id root="a88dd7a1-4f7c-4257-b528-af945c2819d4"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Approved by FDA under NADA # 131-675</paragraph>
                  <paragraph>MERCK <br/>Animal Health</paragraph>
                  <paragraph>Distributed by:<br/> Intervet Inc. (d/b/a Merck Animal Health)<br/>Rahway, NJ 07065</paragraph>
                  <paragraph>Copyright © 2023 Merck &amp; Co., Inc., Rahway, NJ, USA<br/>and its affiliates. All rights reserved.</paragraph>
                  <paragraph>Rev. 10/2023</paragraph>
               </text>
               <effectiveTime value="20241119"/>
            </section>
         </component>
         <component>
            <section>
               <id root="d6cc2131-8f21-4ca3-b544-a2984901ed37"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label</title>
               <text>
                  <paragraph>TO OPEN-PULL NARROW TAPE</paragraph>
                  <paragraph>safe-guard<sup>®</sup>
                     <br/> (fenbendazole)<br/>Dewormer</paragraph>
                  <paragraph>20% Type A<br/> Medicated Article</paragraph>
                  <paragraph>CATTLE: Dairy and Beef Cattle<br/>SWINE: Growing pigs, gilts, pregnant sows and boars<br/>HORSES<br/>Zoo and Wildlife Animals<br/>Growing Turkeys<br/>Wild Quail</paragraph>
                  <paragraph>MUST BE MIXED BEFORE FEEDING ACCORDING TO DIRECTIONS AND PERMITTED CLAIMS.<br/> FOR USE IN MANUFACTURED FEEDS ONLY.</paragraph>
                  <paragraph>ACTIVE DRUG INGREDIENT: Fenbendazole 200 grams per kilogram (90.7 grams per pound).<br/> INERT INGREDIENTS: Roughage Products or Roughage Products and Calcium Carbonate; and Mineral Oil.</paragraph>
                  <renderMultiMedia referencedObject="MM3"/>
               </text>
               <effectiveTime value="20241119"/>
               <component>
                  <observationMedia ID="MM3">
                     <text>PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="safe-03.jpg"/>
                     </value>
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