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   <code code="50576-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"/>
   <title>Topmax™ 9
</title>
   <effectiveTime value="20081112"/>
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      <time/>
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            <name>Elanco Animal Health Co</name>
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                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="230761368" root="1.3.6.1.4.1.519.1"/>
                        <name>Eli Lilly and Company Limited (Speke Operations)</name>
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               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
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                        <name>Topmax</name>
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                              <name>RACTOPAMINE HYDROCHLORIDE</name>
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                              <numerator value="9" unit="g"/>
                              <denominator value="0.45" unit="kg"/>
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                              <code code="309G9J93TP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>RACTOPAMINE HYDROCHLORIDE</name>
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                                 <activeMoiety>
                                    <code code="57370OZ3P1" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>RACTOPAMINE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
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                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="241ATL177A" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SOYBEAN OIL</name>
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                              <numerator value="11.34" unit="kg"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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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">ELANCO*</content> AF0621<br/>
                     <content styleCode="bold">For Use in the Manufacture of Medicated Turkey Feed.<br/>Topmax™ 9<br/>Ractopamine<br/>Hydrochloride</content>
                  </paragraph>
               </text>
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               <title>Type A Medicated Article
</title>
               <text>
                  <table width="100%">
                     <col width="100.000%" align="left"/>
                     <tbody>
                        <tr>
                           <td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule">Do Not Feed Undiluted
</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">Active Drug Ingredient:</content> ractopamine hydrochloride – 9 g per lb (20 g per kg)
</paragraph>
                  <paragraph>
                     <content styleCode="bold">Important:</content> Must be thoroughly mixed into feeds before use. Follow label directions.
</paragraph>
               </text>
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                        <paragraph>
                           <content styleCode="bold">Indications: Toms:</content> For increased rate of weight gain and improved feed efficiency in finishing tom turkeys when fed for the last 14 days prior to slaughter.
</paragraph>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">Hens:</content> For increased rate of weight gain and improved feed efficiency in finishing hen turkeys when fed for the last 7 to 14 days prior to slaughter.
</paragraph>
                        <table width="100%">
                           <col width="50.000%" align="left"/>
                           <col width="50.000%" align="left"/>
                           <tbody>
                              <tr>
                                 <td align="center" valign="top" styleCode="Toprule Lrule Rrule">
                                    <content styleCode="bold">Indications</content>
                                 </td>
                                 <td align="center" valign="top" styleCode="Toprule Rrule">
                                    <content styleCode="bold">Appropriate Concentration of</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" valign="top" styleCode="Botrule Lrule Rrule"/>
                                 <td align="center" valign="top" styleCode="Botrule Rrule">
                                    <content styleCode="bold">Ractopamine in Type C Medicated Feed</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="left" valign="top" styleCode="Lrule Rrule"/>
                                 <td align="left" valign="top" styleCode="Rrule">4.6 to 11.8 g/ton (5 ppm to 13 ppm)
</td>
                              </tr>
                              <tr>
                                 <td align="left" valign="top" styleCode="Lrule Rrule">Toms: Increased Rate of Weight Gain
</td>
                                 <td align="left" valign="top" styleCode="Rrule">No increased benefit has been shown when
</td>
                              </tr>
                              <tr>
                                 <td align="left" valign="top" styleCode="Lrule Rrule">and Improved Feed Efficiency
</td>
                                 <td align="left" valign="top" styleCode="Rrule">ractopamine concentrations in the diet are
</td>
                              </tr>
                              <tr>
                                 <td align="left" valign="top" styleCode="Botrule Lrule Rrule"/>
                                 <td align="left" valign="top" styleCode="Botrule Rrule">greater than 4.6 g/ton (5 ppm).
</td>
                              </tr>
                              <tr>
                                 <td align="left" valign="top" styleCode="Lrule Rrule">Hens: Increased Rate of Weight Gain
</td>
                                 <td align="left" valign="top" styleCode="Rrule"/>
                              </tr>
                              <tr>
                                 <td align="left" valign="top" styleCode="Botrule Lrule Rrule">and Improved Feed Efficiency
</td>
                                 <td align="left" valign="top" styleCode="Botrule Rrule">4.6 to 11.8 g/ton (5 ppm to 13 ppm)
</td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>
                           <content styleCode="bold">Inert Ingredients:</content> Ground corn cobs.
</paragraph>
                     </text>
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                           <text>
                              <paragraph>
                                 <content styleCode="bold">Mixing Directions:</content> Thoroughly mix Topmax 9 Type A Medicated Article into one ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:
</paragraph>
                              <table width="100%">
                                 <col width="23.167%" align="left"/>
                                 <col width="37.933%" align="left"/>
                                 <col width="38.900%" align="left"/>
                                 <tbody>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Toprule Lrule Rrule">
                                          <content styleCode="bold">Pounds of Topmax 9 To Add Per Ton</content>
                                       </td>
                                       <td colspan="2" align="center" valign="top" styleCode="Toprule Rrule">
                                          <content styleCode="bold">Resulting Ractopamine Concentration in Type B Medicated Feed</content>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">
                                          <content styleCode="bold">To Make a Type B Medicated Feed</content>
                                       </td>
                                       <td align="center" valign="middle" styleCode="Botrule">
                                          <content styleCode="bold">grams/ton</content>
                                       </td>
                                       <td align="center" valign="middle" styleCode="Botrule Rrule">
                                          <content styleCode="bold">grams/pound</content>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">100
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">900
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">0.45
</td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">200
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">1,800
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">0.90
</td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">300
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">2,700
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">1.35
</td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">400
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">3,600
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">1.80
</td>
                                    </tr>
                                 </tbody>
                              </table>
                              <paragraph>Thoroughly mix Topmax 9 Type A Medicated Article into one ton of complete turkey feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare an intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients, then add to the remaining feed ingredients to make a ton of complete feed.
</paragraph>
                              <table width="100%">
                                 <col width="46.000%" align="left"/>
                                 <col width="54.000%" align="left"/>
                                 <tbody>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Toprule Botrule Lrule Rrule">
                                          <content styleCode="bold">Pounds of Topmax 9 to Add Per Ton</content>
                                          <br/>
                                          <content styleCode="bold">of Type C Medicated Feed</content>
                                       </td>
                                       <td align="center" valign="top" styleCode="Toprule Botrule Rrule">
                                          <content styleCode="bold">Resulting Ractopamine Concentration in</content>
                                          <br/>
                                          <content styleCode="bold">Type C Medicated Feed</content>
                                       </td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">0.5 lb
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">4.6 g/ton (5 ppm)
</td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">0.9 lb
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">8.2 g/ton (9 ppm)
</td>
                                    </tr>
                                    <tr>
                                       <td align="center" valign="top" styleCode="Botrule Lrule Rrule">1.3 lb
</td>
                                       <td align="center" valign="top" styleCode="Botrule Rrule">11.8 g/ton (13 ppm)
</td>
                                    </tr>
                                 </tbody>
                              </table>
                           </text>
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                                 <text>
                                    <paragraph>
                                       <content styleCode="bold">Feeding Directions:</content> Feed continuously as the sole ration, 4.6 to 11.8 g/ton to finishing tom turkeys for the last 14 days prior to slaughter. Feed continuously as the sole ration, 4.6 to 11.8 g/ton to finishing hen turkeys for the last 7 to 14 days prior to slaughter.
</paragraph>
                                    <paragraph>
                                       <content styleCode="bold">CAUTION:</content> Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.
</paragraph>
                                    <paragraph>Not for animals intended for breeding.
</paragraph>
                                    <paragraph>
                                       <content styleCode="bold">NOT FOR HUMAN USE.</content>
                                    </paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content> The active ingredient in Topmax, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Topmax 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Topmax, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
</paragraph>
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               <text>
                  <paragraph>Store at room temperature. Avoid moisture.
</paragraph>
                  <paragraph>Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date.
</paragraph>
                  <paragraph>To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
</paragraph>
                  <paragraph>Manufactured For: Elanco Animal Health<br/>A Division of Eli Lilly and Company<br/>Indianapolis, IN 46285, U.S.A.
</paragraph>
                  <paragraph>Restricted Drug (California) – Use Only as Directed
</paragraph>
                  <paragraph>NADA 141-290, Approved by FDA
</paragraph>
                  <paragraph>*Elanco<sup>®</sup>, Topmax™, and the diagonal color bar are trademarks of Eli Lilly and Company.
</paragraph>
                  <paragraph>YM9140DEAMM (V01-09-2008)
</paragraph>
                  <paragraph>
                     <content styleCode="bold">TAKE TIME TO</content>
                  </paragraph>
                  <paragraph>
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                  <paragraph>
                     <content styleCode="bold">OBSERVE LABEL DIRECTIONS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Topmax™ 9</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Weight 25 lb</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(11.34 kg)</content>
                  </paragraph>
               </text>
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                  <observationMedia ID="mm01">
                     <text>Figure
</text>
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                     <text>Principle Display Panel
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