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   <title>
      <content styleCode="bold">LINCOMIX<sup>®</sup> 50</content>(lincomycin)</title>
   <effectiveTime value="20221208"/>
   <setId root="c402bfe3-9ceb-4a47-9bfe-55ffd84fc743"/>
   <versionNumber value="9"/>
   <author>
      <time/>
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            <name>Zoetis Inc.</name>
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                     <manufacturedProduct>
                        <code code="54771-1494" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Lincomix 50</name>
                        <formCode code="C42938" displayName="GRANULE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>lincomycin hydrochloride</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator unit="g" value="50"/>
                              <denominator unit="kg" value="0.453"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="M6T05Z2B68" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>LINCOMYCIN HYDROCHLORIDE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="BOD072YW0F" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>LINCOMYCIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="kg" value="22.7"/>
                              <denominator value="1"/>
                           </quantity>
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                     <subjectOf>
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                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
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                     <subjectOf>
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                           <statusCode code="active"/>
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                              <low value="19760630"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>Type A Medicated Article</paragraph>
                  <paragraph>50 grams/lb</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution: Federal law restricts </content>
                     <content styleCode="bold">medicated feed containing this </content>
                     <content styleCode="bold">veterinary feed directive (VFD) drug </content>
                     <content styleCode="bold">to use by or on the order of a </content>
                     <content styleCode="bold">licensed veterinarian.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"> </content>
                  </paragraph>
                  <paragraph>For the control of necrotic enteritis caused or complicated by <content styleCode="italics">Clostridium</content> spp. or other organisms susceptible to lincomycin in broilers.</paragraph>
                  <paragraph>For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) casued by <content styleCode="italics">Lawsonia </content>
                     <content styleCode="italics">intracellularis</content>.</paragraph>
                  <paragraph>For reduction in the severity of the effects of respiratory disease associated with <content styleCode="italics">Mycoplasma hyopneumoniae.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Each pound contains:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Active Drug Ingredient</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">                   </content>Lincomycin………………………………..50 grams</paragraph>
                  <paragraph>                   (as lincomycin hydrochloride agricultural grade)</paragraph>
                  <paragraph>                <content styleCode="bold">Inactive Ingredients   </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">                   </content>Soybean hulls, #20 grind; light liquid paraffin, Ph.Eur.</paragraph>
                  <paragraph> <content styleCode="bold">
                        <br/>
                        <br/>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">IMPORTANT:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Must be thoroughly mixed in feeds before use.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Store opened bag in dry place to prevent caking.<br/>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"> </content>
                     <content styleCode="bold">Store at room temperature.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"> </content>
                  </paragraph>
                  <paragraph>Approved by FDA under NADA # 097-505<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20221208"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>BROILERS</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">BROILERS</content>
                  </paragraph>
                  <paragraph>For the control of necrotic enteritis caused or complicated by <content styleCode="italics">Clostridium</content> spp. or other organisms susceptible to lincomycin in broilers.</paragraph>
                  <paragraph>
                     <content styleCode="bold">DIRECTIONS FOR USE</content>
                     <br/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For the control of necrotic enteritis:</content>
                     <br/>
                  </paragraph>
                  <paragraph>LINCOMIX 50, 50 grams/lb, should be mixed into the complete feed supplied to broiler chickens so that the final feed contains 2 grams of lincomycin per ton of feed.</paragraph>
                  <paragraph>
                     <content styleCode="bold">MIXING DIRECTIONS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Type C Medicated Feeds</content>
                  </paragraph>
                  <table>
                     <col/>
                     <col/>
                     <tbody>
                        <tr>
                           <td align="center">
                              <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">Intermediate Premix</content>
                                 </content>
                              </paragraph>
                              <paragraph>Amount of LINCOMIX 50 per 1000 lb</paragraph> (454 kg) of Feed Ingredients</td>
                           <td align="center">  <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">Complete Feed</content>
                                 </content>
                              </paragraph>
                              <paragraph>Amount of Intermediate Premix to Provide 2 Grams</paragraph>
                              <paragraph>of lincomycin per ton of Type C Medicated Feed</paragraph>
                              <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">lincomycin per ton of feed</content>
                                 </content>
                              </paragraph>
                              <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">2 grams</content>
                                 </content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center">
                              <paragraph> 20 lbs</paragraph>
                              <paragraph>4 lbs</paragraph>
                              <paragraph>2 lbs</paragraph>
                           </td>
                           <td align="center">
                              <paragraph> 2 lbs</paragraph>
                              <paragraph>10 lbs</paragraph>
                              <paragraph>20 lbs</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td> </td>
                           <td> </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">WARNING: </content>When using LINCOMIX 50 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of birds fed LINCOMIX 50 at the approved concentration (2 grams lincomycin per ton of feed).</paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Not for use in layers, breeders, or turkeys. (For additional <content styleCode="bold">Cautions</content>, see below.)</paragraph>
                  <br/>
               </text>
               <effectiveTime value="20221208"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>SWINE</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">SWINE</content>
                  </paragraph>
                  <paragraph>For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by <content styleCode="italics">Lawsonia intracellularis</content>. For reduction in the severity of the effects of respiratory disease associated with <content styleCode="italics">Mycoplasma hyopneumoniae.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DIRECTIONS FOR USE</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For the treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by <content styleCode="italics">Lawsonia intracellularis</content>:</content>
                  </paragraph>
                  <paragraph>Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by <content styleCode="italics">Lawsonia intracellularis</content>:</content>
                  </paragraph>
                  <paragraph>Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear, followed by 40 grams of lincomycin per ton.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For the control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by <content styleCode="italics">Lawsonia intracellularis</content>: </content>Feed 40 grams of lincomycin per ton of complete feed as the sole ration. For use in animals or on premises with a history of swine dysentery, but where symptoms have not yet occurred. </paragraph>
                  <paragraph>
                     <content styleCode="bold">For reduction in the severity of the effects of respiratory disease associated with <content styleCode="italics">Mycoplasma hyopneumoniae</content>
                     </content>:</paragraph>
                  <paragraph>Feed 100-200 grams of lincomycin per ton of complete feed as the sole ration for 21 days.</paragraph>
                  <paragraph>
                     <content styleCode="bold">MIXING DIRECTIONS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Type C Medicated Feeds</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by <content styleCode="italics">Lawsonia intracellularis</content>:</content>
                  </paragraph>
                  <paragraph>To make complete feed containing 100 grams of lincomycin, add 2 lbs of LINCOMIX 50 per ton.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by <content styleCode="italics">Lawsonia intracellularis</content>:</content>
                  </paragraph>
                  <paragraph>To make complete feed containing 40 grams of lincomycin, add 0.8 lbs of LINCOMIX 50 per ton.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For reduction in the severity of the effects of respiratory disease associated with <content styleCode="italics">Mycoplasma hyopneumoniae</content>:</content>
                  </paragraph>
                  <paragraph>To make complete feed containing 100- 200 grams of lincomycin, add 2-4 lbs of LINCOMIX 50 per ton.</paragraph>
                  <paragraph>Additional mixing directions to make complete feed containing 40, 100 or 200 grams of lincomycin per ton are provided below.</paragraph>
                  <paragraph>
                     <content styleCode="bold">MIXING DIRECTIONS</content>
                  </paragraph>
                  <table width="380px">
                     <col/>
                     <col/>
                     <tbody>
                        <tr>
                           <td>  <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">Intermediate</content>
                                    <content styleCode="italics">Premix</content>
                                 </content>
                              </paragraph>
                              <paragraph>Amount of LINCOMIX 50 per 1000 lb</paragraph>
                              <paragraph>(454 kg) of Feed Ingredients</paragraph>
                           </td>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">Complete Feed</content>
                                 </content>
                              </paragraph>
                              <paragraph>Amount of Intermediate Premix to Provide Desired Grams of lincomycin per ton of Type C Medicated Feed</paragraph>
                              <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">lincomycin per ton of feed</content>
                                 </content>
                              </paragraph>  </td>
                        </tr>
                        <tr>
                           <td align="center">
                              <paragraph>50 lbs</paragraph>
                              <paragraph>40 lbs</paragraph>
                              <paragraph>20 lbs</paragraph>
                           </td>
                           <td>  <paragraph>
                                 <content styleCode="bold">
                                    <content styleCode="italics">40 grams              100 grams            200 grams</content>
                                 </content>
                              </paragraph>
                              <paragraph>   16 lbs                     40 lbs                      80 lbs</paragraph>
                              <paragraph>   20 lbs                     50 lbs                     100 lbs</paragraph>
                              <paragraph>   40 lbs                     100 lbs                   200 lbs</paragraph>
                              <br/>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">WARNING: </content>When using LINCOMIX 50 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of swine fed LINCOMIX 50 at approved concentrations (40, 100 or 100-200 grams lincomycin per ton of feed).</paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR HUMAN USE</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Occasionally, swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.<br/>
                  </paragraph>
                  <br/>
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               <effectiveTime value="20221208"/>
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               <title/>
               <text>
                  <paragraph>Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.</paragraph>
                  <paragraph>Good Manufacturing Practices Should Be Observed in Preparing Feeds Containing LINCOMIX 50.</paragraph>
                  <paragraph>This Includes Appropriate Clean-out Procedures to Avoid Cross-Contamination.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Restricted Drug (California) – Use Only as Directed</content>
                  </paragraph>
                  <paragraph>Distributed by:<br/>Zoetis Inc.<br/>Kalamazoo, MI 49007</paragraph>
                  <paragraph>501918</paragraph>
                  <paragraph>40027871</paragraph>
                  <paragraph>Made in China</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL</title>
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                     <text>Lincomix 50 bag label</text>
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