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   <title>
      <content styleCode="bold">Terramycin<sup>®</sup> 100MR </content>
      <br/>
      <content styleCode="bold">(oxytetracycline)</content>
      <br/>
      <content styleCode="bold">TYPE A MEDICATED ARTICLE</content>
   </title>
   <effectiveTime value="20211207"/>
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      <time/>
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            <name>Phibro Animal Health</name>
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                  <name>Phibro Animal Health</name>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="66104-7940" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Terramycin 100 MR</name>
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                           <genericMedicine>
                              <name>oxytetracycline</name>
                           </genericMedicine>
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                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="g" value="100"/>
                              <denominator unit="kg" value="0.45"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="4U7K4N52ZM" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>OXYTETRACYCLINE HYDROCHLORIDE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="SLF0D9077S" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>OXYTETRACYCLINE ANHYDROUS</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
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                           <ingredientSubstance>
                              <code code="IY9XDZ35W2" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>DEXTROSE, UNSPECIFIED FORM</name>
                           </ingredientSubstance>
                        </ingredient>
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                              <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SILICON DIOXIDE</name>
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                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="6OZP39ZG8H" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POLYSORBATE 80</name>
                           </ingredientSubstance>
                        </ingredient>
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                           <quantity>
                              <numerator unit="kg" value="22.7"/>
                              <denominator value="1"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
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                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20100331"/>
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               <title>Active Drug Ingredient:</title>
               <text>
                  <paragraph>Oxytetracycline (from Oxytetracycline Dihydrate Base) Equivalent to</paragraph>
                  <paragraph>Oxytetracycline Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . .100 grams per pound.</paragraph>
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                     <title>Inert ingredients: </title>
                     <text>
                        <paragraph>Dextrose monohydrate.</paragraph>
                     </text>
                     <effectiveTime value="20210825"/>
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               <title>CAUTION: <br/>CAUTION:  Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>For use in manufacturing medicated animal feeds only. For use in dry milk replacers only.</paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Certain components of animal feeds, including medicated premixes, possess properties that may be a potential hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.</paragraph>
                  <paragraph>Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.</paragraph>
               </text>
               <effectiveTime value="20210825"/>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>STORE AT OR BELOW 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)</title>
               <effectiveTime value="20190103"/>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.</title>
               <effectiveTime value="20140423"/>
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               <title>MIXING AND USE DIRECTIONS</title>
               <text>
                  <paragraph>FOR TYPE A MEDICATED ARTICLE QUANTITIES LESS THAN ONE POUND. MIX THE PROPER AMOUNT OF TYPE A MEDICATED ARTICLE WITH AT LEAST TEN POUNDS OF FEED INGREDIENTS TO MAKE A PREBLEND. ADD THE PREBLEND TO THE REMAINING FEED INGREDIENTS AND MIX THOROUGHLY.</paragraph>
                  <table width="100%">
                     <col width="33%"/>
                     <col width="33%"/>
                     <col width="33%"/>
                     <tbody>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">INDICATIONS FOR USE</content>
                              </paragraph>
                           </td>
                           <td styleCode="Rrule Botrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">Use Level of Terramycin</content>
                              </paragraph>
                           </td>
                           <td styleCode="Rrule Botrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">LB OF Terramycin 100MR/TON</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">CALVES - MILK REPLACERS</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>Treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>10 mg/lb body weight daily Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>20<sup>1</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">
                                    <sup>1</sup>Calf weighing 100 lbs. consuming 1 lb. of dry milk replacer mixed with one gallon water.</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">HONEY BEES</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <paragraph>Control of American Foulbrood caused by Paenibacillus larvae, and European Foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>200 mg/oz (Dusting)</paragraph>
                              <paragraph>200 mg/5 lb (Syrup)</paragraph>
                              <paragraph>800 mg/patty </paragraph>
                              <paragraph>(Extender Patty)</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>See Mixing, Preparation, and Feeding Directions below</paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">Mixing and Use Directions for Honey Bees</content>
                  </paragraph>
                  <paragraph>To manufacture a Type C medicated feed containing 200 mg of oxytetracycline hydrochloride activity per oz (dusting Type C Medicated feed) mix 7 lb of Terramycin 100MR with 211 lb of powdered sugar (for a total of 218 lb). The resulting Type C medicated is fed as-is for dusting or may be used to prepare syrup and extender patty feeds. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Feeding Directions for Dusting:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Dusting: </content>Apply 1 oz (200 mg oxytetracycline) of dusting Type C medicated feed per colony every 4 to 5 days for a total of 3 applications.  Apply the dust on the outer parts or ends of the frames.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution: </content>Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Preparation and Feeding Directions for Syrup:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Preparation:  </content>First dissolve 1 oz (200 mg oxytetracycline) of the dusting Type C medicated feed in a small quantity of water, then mix into 5 lb of 1:1 sugar syrup (equal parts sugar and water. w/w).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Feeding</content>: Feed 5 lb of syrup (200 mg oxytetracycline) per colony every 4 to 5 days for a total of 3 applications. Bulk feed the syrup using feeder pails, or division board feeders, or by filling the combs. Prepare fresh syrup for each application.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Preparation and Feeding Directions for Extender Patty: </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Preparation: </content>Make one patty by mixing 4 oz (800 mg oxytetracycline) of the dusting Type C medicated with 5.8 oz. (165 g) of vegetable shortening and 11.6 oz (330 g) of sugar. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Feeding: </content>Place one patty per colony on the top bars of the brood nest frames in a single application.</paragraph>
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               <effectiveTime value="20210825"/>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNING: </title>
               <text>
                  <paragraph>►<content styleCode="bold">Withdrawal Periods and Residue Warnings: </content>Remove at least 6 weeks prior to main honey flow. Type C medicated feeds should be fed in the spring or fall and consumed by the bees before main honey begins to avoid contamination of production honey. Honey stored during medication periods in combs for surplus honey should be removed following final medication of the bee colony and must not be used for human food.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Warning: </content>Do not use in a manner contrary to state apiary laws and regulations. Each state has specific regulations relative to disease control and medications. Contact the appropriate official or state departments of agriculture for specific inter- and intrastate laws and regulations.</paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR HUMAN USE.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED.</content>
                  </paragraph>
               </text>
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               <text>
                  <paragraph>SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,</paragraph>
                  <paragraph>USE DIRECTIONS AND WARNINGS.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Terramycin is a registered trademark of Pfizer, Inc., </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">licensed to Phibro Animal Health Corporation for Oxytetracycline </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">PHIBRO and PHIBRO logo design are trademarks owned by</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Phibro Animal Health Corporation or its affiliates.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Phibro Animal Health Corporation, Teaneck, NJ 07666</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA #095-143</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">7940000</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">101-9079-07</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Weight 50 lb (22.7 kg)</content>
                  </paragraph>
               </text>
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