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   <title>SYNOVEX<sup>®</sup> ONE GROWER</title>
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            <name>Zoetis Inc.</name>
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                        <name>Synovex One</name>
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                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>trenbolone acetate and estradiol benzoate</name>
                           </genericMedicine>
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                              <numerator unit="mg" value="150"/>
                              <denominator unit="1" value="1"/>
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                              <name>TRENBOLONE ACETATE</name>
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                                    <name>TRENBOLONE</name>
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                              <numerator unit="mg" value="21"/>
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                              <name>ESTRADIOL BENZOATE</name>
                              <activeMoiety>
                                 <activeMoiety>
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                              <numerator unit="1" value="10"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">SYNOVEX<sup>®</sup> ONE GROWER<br/>
                     </content>(trenbolone acetate and estradiol benzoate extended-release implants)<br/>150 mg trenbolone acetate and 21 mg estradiol benzoate per implant</paragraph>
                  <paragraph>
                     <content styleCode="bold">SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS ON PASTURE AND FED IN CONFINEMENT FOR SLAUGHTER</content>
                  </paragraph>
               </text>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>Description</title>
               <text>
                  <paragraph>SYNOVEX ONE Grower (trenbolone acetate and estradiol benzoate extended-release implants) is a growth promoting implant containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate per implant with a porous polymer film coating that extends the pay-out period of the final formulation up to 200 days. Each implant consists of six pellets. Ten implants are provided in each cartridge.</paragraph>
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               <title>DOSAGE<br/>
               </title>
               <text>
                  <paragraph>One implant (six pellets), containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate, is administered to each steer or heifer by subcutaneous implantation in the middle one‑third of the ear.<br/>
                     <br/>The ten-dose cartridge of SYNOVEX ONE Grass is designed to be used exclusively with a Synovex Applicator.</paragraph>
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               <code code="50743-4" codeSystem="2.16.840.1.113883.6.1" displayName="FOOD SAFETY WARNING SECTION"/>
               <title>WITHDRAWAL PERIODS AND RESIDUE WARNINGS</title>
               <text>
                  <paragraph>No withdrawal period is required when used according to labeling.<br/>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.<br/>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.<br/>Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.</paragraph>
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               <title>USER SAFETY WARNINGS</title>
               <text>
                  <paragraph>Not for use in humans. Keep out of reach of children.</paragraph>
               </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>ANIMAL SAFETY WARNING<br/>
               </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 ONE Grower implants.</paragraph>
               </text>
               <effectiveTime value="20211109"/>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS<br/>
               </title>
               <text>
                  <paragraph>Each cartridge cell holds one implant (6 pellets), containing 150 mg trenbolone acetate and 21 mg of estradiol benzoate.<br/>Administer complete contents of one cartridge cell (one implant) to each steer or heifer by subcutaneous implantation in the middle one-third of the ear.<br/>The ten-dose cartridge of SYNOVEX ONE Grower is designed to be used exclusively with a Synovex® applicator. Approved implantation technique is fully described in the fold-out carton section. <content styleCode="bold">Never sacrifice careful, clean technique for speed of implantation.</content>
                  </paragraph>
               </text>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>STORAGE<br/>
               </title>
               <text>
                  <paragraph>Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity.<br/>Use product before the expiration date on the label.<br/>Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) for up to one month.</paragraph>
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               <code code="50742-6" codeSystem="2.16.840.1.113883.6.1" displayName="ENVIRONMENTAL WARNING SECTION"/>
               <title>DISPOSAL<br/>
               </title>
               <text>
                  <paragraph>SYNOVEX ONE Grower waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.</paragraph>
               </text>
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               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>INDICATIONS FOR USE<br/>
               </title>
               <text>
                  <list listType="unordered" styleCode="Disk">
                     <item>For increased rate of weight gain for up to 200 days in growing beef steers and heifers on pasture (stocker, feeder and slaughter).</item>
                     <item>For increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter.</item>
                     <item>Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within each separate production phase:<list listType="unordered" styleCode="Disc">
                           <item>growing beef steers and heifers on pasture (stocker, feeder and slaughter);</item>
                           <item>growing beef steers and heifers fed in confinement for slaughter.</item>
                        </list>
                     </item>
                     <item>Safety and effectiveness following reimplantation have not been evaluated</item>
                  </list>
                  <paragraph>Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.<br/>
                     <br/> Do not use in animals intended for subsequent breeding, or in dairy cows.<br/>
                     <br/> NOTE: The administration of SYNOVEX ONE Grower may result in decreased marbling scores when compared to non-implanted steers and heifers.</paragraph>
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               <title>NET CONTENTS</title>
               <text>
                  <paragraph>NET CONTENTS: 10 CARTRIDGES<br/>Each Cartridge Contains 10 implants (100 implants total)</paragraph>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>Manufactured By A Non-Sterilizing Process<br/>
                     <br/>Restricted Drug (California)—<br/>Use Only As Directed.<br/>
                     <br/>
                     <content styleCode="bold">IMPORTANT</content>:<br/>Read ALL sides of carton<br/>
                     <br/>Approved by FDA under NADA # 141-348<br/>
                     <br/>
                     <content styleCode="bold">zoetis</content>
                     <br/>
                     <br/>Distributed by:<br/>Zoetis Inc.<br/>Kalamazoo, MI 49007<br/>
                     <br/>40034339<br/>
                  </paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton</title>
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                  <paragraph>40034339</paragraph>
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                     <text>Carton label</text>
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