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   <title>Synovex H</title>
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            <name>Zoetis Inc.</name>
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                        <name>Synovex H</name>
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                              <name>testosterone propionate and estradiol benzoate</name>
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                              <name>TESTOSTERONE PROPIONATE</name>
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                                    <name>TESTOSTERONE</name>
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                              <name>ESTRADIOL BENZOATE</name>
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                                    <name>ESTRADIOL</name>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                              <low value="20141107"/>
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               <title/>
               <text>
                  <paragraph>Synovex® H</paragraph>
                  <paragraph>(testosterone propionate and estradiol benzoate implants)<br/>200 mg testosterone propionate and 20 mg estradiol benzoate per implant<br/>
                     <br/>
                     <content styleCode="bold">SUBCUTANEOUS IMPLANTS FOR GROWING BEEF HEIFERS FED IN CONFINEMENT FOR SLAUGHTER</content>
                     <br/>
                     <br/>This product was manufactured by a non-sterilizing process.<br/>
                     <br/>TAKE TIME OBSERVE LABEL DIRECTIONS<br/>
                     <br/>Important: Read ALL sides of carton<br/>
                     <br/>For subcutaneous ear implantation only.<br/>
                     <br/>Approved by FDA under NADA # 011-427</paragraph>
                  <paragraph>NET CONTENTS: 10 CARTRIDGES<br/>Each Cartridge Contains 10 implants (100 implants total)</paragraph>
                  <paragraph>Restricted Drug (California) — Use Only as Directed</paragraph>
               </text>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>WITHDRAWAL PERIODS AND RESIDUE WARNINGS</title>
               <text>
                  <paragraph>No withdrawal period is required when used according to labeling. Do not 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. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Implant pellets subcutaneously in ear only. Any other location is a violation of Federal Law.<br/>
                     <br/>Do not attempt salvage of implanted site for human or animal food.</paragraph>
               </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>USER SAFETY WARNINGS</title>
               <text>
                  <paragraph>Not for use in humans. Keep out of reach of children.<br/>
                  </paragraph>
               </text>
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               <title>ANIMAL SAFETY WARNINGS</title>
               <text>
                  <paragraph>Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX® H implants.<br/>
                  </paragraph>
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               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>INDICATIONS FOR USE</title>
               <text>
                  <paragraph>· For increased rate of weight gain and improved feed efficiency in growing beef heifers fed in confinement for slaughter.<br/>· Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated.<br/>
                     <br/>Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated.<br/>Do not use in animals intended for subsequent breeding, or in dairy cows.</paragraph>
               </text>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Dosage</title>
               <text>
                  <paragraph>Implant complete contents of one cartridge cell per heifer. Approved implantation technique is fully described in the package insert.</paragraph>
                  <paragraph>
                     <content styleCode="bold">NOTE: </content>Never sacrifice careful, clean technique for speed of implantation.</paragraph>
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                     <text>Instructions graphic part 1</text>
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                     <text>Instructions graphic part 2</text>
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                     <text>Instructions graphic part 3</text>
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               <title>DIRECTIONS</title>
               <text>
                  <paragraph>Implant complete contents of one cartridge cell per heifer. Approved implantation technique is fully described in the package insert.<br/>
                     <br/>
                     <content styleCode="bold">NOTE</content>: Never sacrifice careful, clean technique for speed of implantation.</paragraph>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage</title>
               <text>
                  <paragraph>Store at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.</paragraph>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>HOW SUPPLIED</title>
               <text>
                  <paragraph>100 Dose</paragraph>
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               <title>QUESTIONS/COMMENTS?</title>
               <text>
                  <paragraph>For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.<br/>
                  </paragraph>
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               <title/>
               <text>
                  <paragraph>Distributed by:<br/>Zoetis Inc.<br/>Kalamazoo, MI 49007<br/>
                     <br/>Revised: May 2023<br/>40039999</paragraph>
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               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - Carton of 10 cartridges</title>
               <text>
                  <paragraph>40039999</paragraph>
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                     <text>carton label</text>
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