<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="45526c6c-2d2e-46c4-bba4-25a0334b42ae"/>
   <code code="50575-0" codeSystem="2.16.840.1.113883.6.1" displayName="VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"/>
   <title>
      <content styleCode="bold">Terramycin<sup>®</sup> 100 </content>
      <br/>
      <content styleCode="bold">(oxytetracycline)</content>
      <br/>
      <content styleCode="bold">TYPE A MEDICATED ARTICLE</content>
   </title>
   <effectiveTime value="20230719"/>
   <setId root="97bfb783-071a-48d4-9d78-76ea2d4024f4"/>
   <versionNumber value="10"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="006989008" root="1.3.6.1.4.1.519.1"/>
            <name>Phibro Animal Health</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="006989008" root="1.3.6.1.4.1.519.1"/>
                  <name>Phibro Animal Health</name>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="9e674dce-bc49-44fc-a7fc-d6b2ab4d6eae"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20210901"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="66104-7100" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Terramycin 100</name>
                        <formCode code="C42972" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>oxytetracycline</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <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>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="T5L8T28FGP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MINERAL OIL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="H0G9379FGK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CALCIUM CARBONATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="R60QEP13IC" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>RICE BRAN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="kg" value="22.7"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="66104-7100-0" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BAG"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA095143" root="2.16.840.1.113883.3.150"/>
                           <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20100331"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="i4i_description_id_7f60afca-f397-4a74-b9d1-b1dba219d300">
               <id root="9c9461f5-0fd0-4148-be02-411d33360919"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>Active Drug Ingredient:</title>
               <text>
                  <paragraph>Oxytetracycline (from oxytetracycline dihydrate base) equivalent to</paragraph>
                  <paragraph>oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb</paragraph>
               </text>
               <effectiveTime value="20230718"/>
            </section>
         </component>
         <component>
            <section ID="i4i_warnings_precautions_id_9fca3bf1-ec7a-4123-a909-c09f896e18f3">
               <id root="bc4ae0e2-cd9e-476f-8ae6-6aff6c307770"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>CAUTION: </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>For use in manufacturing medicated animal feeds only.</paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health 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="20230719"/>
            </section>
         </component>
         <component>
            <section ID="i4i_storage_id_0ff0cb3b-00a7-4fcd-ab0c-30272e71672a">
               <id root="3dd59b15-f617-4940-a632-4bf6e52de836"/>
               <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>
               <text>
                  <paragraph>
                     <content styleCode="bold">SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">USE DIRECTIONS, AND WARNINGS</content>
                  </paragraph>
                  <paragraph>Terramycin is a registered trademark of Pfizer, Inc.,</paragraph>
                  <paragraph>licensed to Phibro Animal Health Corporation, for Oxytetracycline</paragraph>
                  <paragraph>PHIBRO and PHIBRO logo design are trademarks owned by</paragraph>
                  <paragraph>Phibro Animal Health Corporation or its affiliates</paragraph>
                  <paragraph>Phibro Animal Health Corporation, Teaneck, NJ 07666</paragraph>
                  <paragraph>Net Weight 50 lb (22.7 kg)</paragraph>
                  <paragraph>Approved by FDA under NADA # 095-143</paragraph>
                  <paragraph>8844000</paragraph>
                  <paragraph>101-9008-10</paragraph>
               </text>
               <effectiveTime value="20230719"/>
            </section>
         </component>
         <component>
            <section ID="i4i_dosage_admin_id_d754abae-db26-4e74-8397-940c539d3465">
               <id root="0da4b1df-5811-4629-bb1a-ad5216716781"/>
               <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>
               <text>
                  <paragraph>
                     <content styleCode="bold">Mixing and Use Directions</content>
                  </paragraph>
                  <paragraph>Thoroughly mix the amount of this Type A medicated article according to the directions below with at least an equal amount by weight of feed formula ingredients prior to blending into a complete feed.</paragraph>
                  <table width="100%">
                     <colgroup>
                        <col width="36%"/>
                        <col width="32%"/>
                        <col width="32%"/>
                     </colgroup>
                     <tbody>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule Toprule" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Indications for Use</content>
                              </paragraph>
                           </td>
                           <td styleCode="Botrule Rrule Toprule" align="center" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Oxytetracycline Amount</content>
                              </paragraph>
                           </td>
                           <td styleCode="Botrule Rrule Toprule" align="center" valign="top">
                              <paragraph>
                                 <content styleCode="bold">lb of </content>
                                 <br/>
                                 <content styleCode="bold">Terramycin 100/ton</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">CHICKENS</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Control of infectious synovitis caused by <content styleCode="italics">Mycoplasma synoviae</content>; control of fowl cholera caused by <content styleCode="italics">Pasteurella multocida</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>100-200 g/ton</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>1-2</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Control of chronic respiratory disease (CRD) and air sac infection caused by <content styleCode="italics">Mycoplasma gallisepticum</content> and <content styleCode="italics">Escherichia coli</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>400 g/ton</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>4</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Reduction of mortality due to air sacculitis (air sac infection) caused by <content styleCode="italics">Escherichia coli</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>500 g/ton</paragraph>
                              <paragraph>Feed continuously for 5 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>5</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. Do not use in low-calcium feed containing less than 0.55 dietary calcium. Use in such may result in violative residues. Do not administer to chickens producing eggs for human consumption.</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">TURKEYS</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Control of hexamitiasis caused by <content styleCode="italics">Hexamita meleagridis</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>100 g/ton</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>1</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Control of infectious synovitis caused by <content styleCode="italics">Mycoplasma synoviae</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>200 g/ton</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>2</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>25 mg/lb of body weight daily</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>8.3<sup>1</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption.</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">SWINE</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Treatment of bacterial enteritis caused by <content styleCode="italics">Escherichia coli</content> and <content styleCode="italics">Salmonella choleraesuis </content>susceptible to oxytetracycline and treatment of bacterial pneumonia caused by <content styleCode="italics">Pasteurella multocida</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>10 mg/lb of body weight daily</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>5<sup>2</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by <content styleCode="italics">Leptospira pomona </content>susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>10 mg/lb of body weight daily</paragraph>
                              <paragraph>Feed continuously for not more than 14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>5<sup>2</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>For growing cattle (over 400 lb) for the reduction of the incidence of liver abscesses</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>75 mg/head/day</paragraph>
                              <paragraph>Feed continuously</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>0.75<sup>3</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Prevention and treatment of the early stages of shipping fever complex (Feed 3-5 days before and after arrival in feedlots.)</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>0.5-2.0 g/head/day</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>5-20<sup>3</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Treatment of bacterial enteritis caused by <content styleCode="italics">Escherichia coli</content> and bacterial pneumonia (shipping fever complex) caused by <content styleCode="italics">Pasteurella multocida</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>10 mg/lb of body weight daily</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>50<sup>4</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">SHEEP</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" valign="top">
                              <paragraph>Treatment of bacterial enteritis caused by <content styleCode="italics">Escherichia coli</content> and bacterial pneumonia caused by <content styleCode="italics">Pasteurella multocida</content> susceptible to oxytetracycline</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>10 mg/lb of body weight daily</paragraph>
                              <paragraph>Feed continuously for 7-14 days</paragraph>
                           </td>
                           <td styleCode="Botrule Rrule" align="center" valign="top">
                              <paragraph>12<sup>5</sup>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">WARNING: 5-day withdrawal before slaughter.</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" valign="top">
                              <paragraph>
                                 <sup>1</sup>If bird weighs 10 lb, consuming 0.6 lb of complete feed per day</paragraph>
                              <paragraph>
                                 <sup>2</sup>Pig consuming 4 lb of complete feed per 100 lb body weight per day</paragraph>
                              <paragraph>
                                 <sup>3</sup>Include in feed supplement based on consumption of 2 lb of supplement per head per day</paragraph>
                              <paragraph>
                                 <sup>4</sup>If animal weighs 500 lb, consuming 2 lb of supplement per head per day</paragraph>
                              <paragraph>
                                 <sup>5</sup>If lamb weighs 60 lb, consuming 1 b of supplement per head per day</paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR HUMAN USE</content>
                  </paragraph>
               </text>
               <effectiveTime value="20230719"/>
            </section>
         </component>
         <component>
            <section ID="ID_9749d1db-6598-45c8-870e-5ed00e7efab0">
               <id root="3bffcb6f-a90f-4897-a39a-ff9c18139306"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="ID_554724f3-2cd2-43a7-8753-74161bec1ea1"/>
                     <renderMultiMedia referencedObject="ID_554724f3-2cd2-43a7-8753-74161bec1ea1"/>
                  </paragraph>
               </text>
               <effectiveTime value="20230719"/>
               <component>
                  <observationMedia ID="ID_554724f3-2cd2-43a7-8753-74161bec1ea1">
                     <text>Terramycin 100</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Terramycin 100.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>