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   <title>SYNOVEX Choice<sup>®</sup>
   </title>
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            <name>Zoetis Inc.</name>
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                        <name>Synovex Choice</name>
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                              <name>trenbolone acetate and estradiol benzoate</name>
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                              <name>TRENBOLONE ACETATE</name>
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                                    <name>TRENBOLONE</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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               <title/>
               <text>
                  <paragraph>SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS ON PASTURE, IN A DRY LOT AND FED IN CONFINEMENT FOR SLAUGHTER<br/>
                     <br/>
SYNOVEX Choice®<br/>
(trenbolone acetate and estradiol benzoate implants)<br/>
                     <br/>
100 mg trenbolone acetate and 14 mg estradiol benzoate per implant</paragraph>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title/>
               <text>
                  <paragraph>SYNOVEX Choice® (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 100 mg of trenbolone acetate and 14 mg of estradiol benzoate per implant. Each implant consists of 4 pellets. Ten implants are provided in each cartridge.<br/>
                     <br/>
                     <content styleCode="bold">NOTE</content>: Administration of a single SYNOVEX Choice® implant or its use in a reimplantation program with a SYNOVEX Choice®, SYNOVEX Plus®, or SYNOVEX® ONE Feedlot implant may result in decreased marbling scores when compared to non-implanted steers and heifers.</paragraph>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WITHDRAWAL PERIODS AND RESIDUE WARNINGS</title>
               <text>
                  <paragraph>No withdrawal period is required when used according to labeling.<br/>
                     <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/>
                     <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/>
                     <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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               <code code="54433-8" codeSystem="2.16.840.1.113883.6.1" displayName="USER SAFETY WARNINGS 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 Choice® implants.<br/>
                  </paragraph>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS</title>
               <text>
                  <paragraph>Administer one SYNOVEX Choice® implant (four pellets), containing 100 mg of trenbolone acetate and 14 mg of estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear. If using in a reimplantation program, reimplant steers or heifers 60 to 120 days later with a SYNOVEX Choice®, SYNOVEX Plus®, or SYNOVEX® ONE Feedlot implant.<br/>
                     <br/>Use only 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>
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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 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. Use product before the expiration date on the label.<br/>
                     <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</title>
               <text>
                  <paragraph>SYNOVEX Choice® waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.</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>
                  <list listType="unordered" styleCode="Disk">
                     <item>For increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter).</item>
                     <item>For increased rate of weight gain in growing beef steers and heifers in a dry lot.</item>
                     <item>For increased rate of weight gain in growing beef steers fed in confinement for slaughter and for increased rate of weight gain and improved feed efficiency in growing beef heifers fed in confinement for 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 in a reimplantation program where SYNOVEX Choice® is the first implant and a SYNOVEX Choice®, SYNOVEX Plus®, or SYNOVEX® ONE Feedlot implant is administered 60 to 120 days later.</item>
                     <item>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 steers and heifers fed in confinement for slaughter, on pasture, or in a dry lot as safety and effectiveness 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.</paragraph>
                  <paragraph>Do not use in animals intended for subsequent breeding, or in dairy cows.</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.</paragraph>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>SYNOVEX Plus® (trenbolone acetate and estradiol benzoate implants) and SYNOVEX® ONE Feedlot (trenbolone acetate and estradiol extended-release implants) are owned by Zoetis.<br/>
Manufactured By A Non-Sterilizing Process<br/>
                     <br/>
Restricted Drug (California)—Use Only As Directed.</paragraph>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>IMPORTANT</title>
               <text>
                  <paragraph>Read ALL sides of carton</paragraph>
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               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">NET CONTENTS: 10 CARTRIDGES</content>
                     <br/>
Each Cartridge Contains 10 implants (100 implants total)</paragraph>
                  <paragraph>Approved by FDA under NADA # 141-043<br/>
                     <br/>
zoetis<br/>
                     <br/>
Distributed by:<br/>
Zoetis Inc.<br/>
Kalamazoo, MI 49007<br/>
                     <br/>
40049036</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton</title>
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                  <paragraph>40049036</paragraph>
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                     <text>Steps</text>
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                     <text>applicators</text>
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