<?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="5108f39f-e1ed-4b6b-bf7b-1715877ec7b2"/>
   <code code="50575-0" codeSystem="2.16.840.1.113883.6.1" displayName="VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"/>
   <title>Pennox 50<sup>®</sup>
   </title>
   <effectiveTime value="20231024"/>
   <setId root="9aaa1a5f-2234-4de8-8d9a-43a5ce5bfaca"/>
   <versionNumber value="8"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="833270817" root="1.3.6.1.4.1.519.1"/>
            <name>Pharmgate Animal Health</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="079628671" root="1.3.6.1.4.1.519.1"/>
                  <name>Pharmgate Inc.</name>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section ID="DLDE">
               <id root="28ca146d-15ea-4f8f-a053-e687513ac4aa"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
               <effectiveTime value="20231024"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="51429-053" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Pennox 50</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 value="110" unit="g"/>
                              <denominator value="1" unit="kg"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="X20I9EN955" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Oxytetracycline</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="H0G9379FGK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Calcium Carbonate</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="T5L8T28FGP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Mineral Oil</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="22.68" unit="kg"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="51429-053-02" 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="NADA138938" 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="20081223"/>
                           </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 root="228c28e2-4773-4497-94ba-5cb392b68c21"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Oxytetracyline</paragraph>
                  <paragraph>Type A Medicated Article</paragraph>
               </text>
               <effectiveTime value="20231024"/>
            </section>
         </component>
         <component>
            <section>
               <id root="c7815796-3763-4820-a179-7d4cc43cdd60"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Active Drug Ingredients:</content> Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50 grams Oxytetracycline Hydrochloride/lb.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Ingredients:</content> Oxytetracycline, Calcium Carbonate, Roughage Products and Mineral Oil.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For Use in the Manufacture of Medicated Feeds.  Do Not Feed Undiluted.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20231024"/>
            </section>
         </component>
         <component>
            <section>
               <id root="628c7475-33c2-4887-8c98-20443e794a74"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION: For use in Dry Feeds ONLY.  NOT FOR USE IN LIQUID FEED SUPPLEMENTS</content>
                  </paragraph>
               </text>
               <effectiveTime value="20231024"/>
            </section>
         </component>
         <component>
            <section>
               <id root="d38f625d-c46b-496b-9af1-40f72c840b0e"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>Directions For Use</title>
               <text>
                  <table width="95%">
                     <col width="60%" align="left" valign="top"/>
                     <col width="20%" align="center" valign="top"/>
                     <col width="20%" align="center" valign="top"/>
                     <thead>
                        <tr>
                           <th styleCode="Lrule" valign="middle">Indications For Use</th>
                           <th valign="bottom">Use Level of  Oxytetracycline</th>
                           <th styleCode="Rrule">lbs. of Pennox 50 per ton</th>
                        </tr>
                     </thead>
                     <tfoot>
                        <tr>
                           <td align="left" valign="top" colspan="3">
                              <content styleCode="bold">Approved by FDA under NADA # 138-938</content>
                           </td>
                        </tr>
                        <tr>
                           <td align="left" valign="top" colspan="3">
                              <content styleCode="bold">Pennox 50® is the registered trademark of Pharmgate Inc.</content>
                           </td>
                        </tr>
                     </tfoot>
                     <tbody>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Chickens</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Chickens:</content> Control of infectious synovitis caused by <content styleCode="italics">Mycoplasma synoviae,</content> control of fowl cholera caused by <content styleCode="italics">Pasteurella multocida</content> sensitive to oxytetracycline.  (Feed continuously for 7 - 14 days)</td>
                           <td>100-200 g/ton</td>
                           <td styleCode="Rrule">2.0 – 4.0</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Chickens:</content> 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.  (Feed continuously for 7 - 14 days).</td>
                           <td>400 g/ton</td>
                           <td styleCode="Rrule">8.0</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Broiler Chickens:</content> Reduction of mortality due to air sacculitis (air sac infection) caused by <content styleCode="italics">Escherichia coli</content> susceptible to oxytetracycline (Feed continuously for 5 days).</td>
                           <td valign="middle">500 g/ton</td>
                           <td styleCode="Rrule" valign="middle">10.0</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3" align="center">
                              <content styleCode="bold">Withdrawal Periods and Residue Warnings:</content> Do not feed to chickens producing eggs for human consumption.  Do not use in low calcium feed containing less than 0.55% dietary calcium.  Use in such feeds may result in violative residues.  24 hour withdrawal period at 500 g/ton use level.  No withdrawal period is required when used according to labeling at 100 – 200 g/ton and 400 g/ton use levels. 									</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Turkeys</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Turkeys:</content> Control of hexamitiasis caused by <content styleCode="italics">Hexamita meleagridis</content> susceptible to oxytetracycline.  (Feed continuously for 7 - 14 days).</td>
                           <td>100 g/ton</td>
                           <td styleCode="Rrule">2.0</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Turkeys:</content> Control of infectious synovitis caused by <content styleCode="italics">Mycoplasma synoviae</content>  susceptible to oxytetracycline (Feed continuously for 7 - 14 days)</td>
                           <td>200g/ton</td>
                           <td styleCode="Rrule">4.0</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Turkeys:</content> Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline. (Feed continuously for 7 - 14 days)</td>
                           <td styleCode="Rrule" colspan="2" valign="middle">25 mg/lb body weight/day</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3">
                              <content styleCode="bold">Withdrawal Periods and Residue Warnings:</content> Do not feed to turkeys producing eggs for human consumption.  Zero-day withdrawal period. 									</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Swine</content>
                           </td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Swine:</content> 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. (Feed continuously for 7-14 days.)</td>
                           <td styleCode="Rrule" colspan="2">Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb body weight/ day.</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Breeding Swine:</content> 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.  (Feed continuously for 14 days)</td>
                           <td styleCode="Rrule" colspan="2">Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb body weight/ day.</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3">
                              <content styleCode="bold">Withdrawal Periods:</content> Zero-day withdrawal period. 									</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Calves, Beef Cattle, and Nonlactating Dairy Cattle</content>
                           </td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3"> </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Growing Cattle (over 400 lbs.):</content>  For the reduction of the incidence of liver abscesses. (Use continuously)</td>
                           <td styleCode="Rrule" colspan="2">75 mg/head/day</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Cattle:</content> For the prevention and treatment of the early stages of the shipping fever complex.  (Feed 3-5 days before and after arrival in feedlots.)</td>
                           <td styleCode="Rrule" colspan="2">0.5-2.0g/head/day</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Calves, Beef Cattle, and Nonlactating Dairy Cattle:</content> 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. (Feed continuously for 7-14 days)</td>
                           <td styleCode="Rrule" colspan="2">10 mg/lb. body weight/day</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3">
                              <content styleCode="bold">Withdrawal Periods and Residue Warnings:</content> This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows.  Use in these cattle may cause drug residues in milk, and/or in calves born to these cows.  5-day withdrawal period at 10 mg/lb. body weight/day use level.  No withdrawal period is required when used according to labeling at 75 mg/head/day and 0.5 – 2.0 g/head/day use level. 									</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Sheep</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">For Sheep:</content> 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. (Feed continuously for 7-14 days)</td>
                           <td styleCode="Rrule" colspan="2">10 mg/lb. body weight/day</td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule Rrule" colspan="3">
                              <content styleCode="bold">Withdrawal Periods:</content> 5-day withdrawal period. 									</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Honey Bees</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule">
                              <content styleCode="bold">Honey Bees:</content> Control of American Foulbrood caused by <content styleCode="italics">Paenibacillus larvae,</content> and European Foulbrood caused by <content styleCode="italics">Melissococcus plutonius</content> susceptible to oxytetracycline.</td>
                           <td styleCode="Rrule" colspan="2">200 mg/oz (Dusting)<br/>200 mg/5 lb (Syrup)<br/>800 mg/paty (Extender Patty)</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="3" align="center">See Mixing, Preparation, and Feeding Directions below. 									</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Mixing Directions for Honey Bees</content>
                              <br/>To manufacture a Type B medicated feed containing 20g/lb of oxytetracycline hydrochloride activity, mix 10 lb of Pennox 50 with 15 lb of powdered sugar (for a total of 25 lb.)  To manufacture a Type C medicated feed containing 200 mg of oxytetracycline hydrochloride activity per oz (dusting Type C medicated feed), mix 14 lb of Pennox 50 with 204 lb of powdered sugar (for a total of 218 lb).  The resulting Type C medicated feed is fed as-is for dusting, or is used to prepare syrup and extender patty feeds.<br/>
                              <content styleCode="bold">Feeding Directions for Dusting:</content>
                              <br/>
                              <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.<br/>
                              <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.<br/>
                              <content styleCode="bold">Preparation and Feeding Directions for Syrup:</content>
                              <br/>
                              <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).<br/>
                              <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.<br/>
                              <content styleCode="bold">Preparation and Feeding Directions for Extender Patty:</content>
                              <br/>
                              <content styleCode="bold">Preparation:</content> Make one patty by mixing 4 oz (800 mg oxytetracycline) of the dusting Type C medicated feed with 5.8 oz (165 g) of vegetable shortening and 11.6 oz (330 g) of sugar.<br/>
                              <content styleCode="bold">Feeding:</content> Place one patty per colony on the top bars of the brood nest frames in a single application. 									</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" colspan="3">
                              <content styleCode="bold">Warnings:</content>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" colspan="3" align="center">
                              <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 flow 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.</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" colspan="3">
                              <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. 									</td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20231024"/>
            </section>
         </component>
         <component>
            <section>
               <id root="1c2820aa-4090-4c3b-8136-be056aca672b"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Marketed by:<br/>
                     <content styleCode="bold">Pharmgate Animal Health, LLC</content>
                     <br/>14040 Industrial Road<br/>Omaha, NE 68144</paragraph>
                  <paragraph>Take Time<renderMultiMedia referencedObject="MM1"/>Observe Directions</paragraph>
               </text>
               <effectiveTime value="20231024"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>Image</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="pennox-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="9a90e4d7-7bad-46dc-948d-c34851bba99d"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 22.68 Kg Bag Label</title>
               <text>
                  <paragraph>Pennox 50<sup>®</sup>
                  </paragraph>
                  <paragraph>Oxytetracycline<br/>Type A Medicated Article</paragraph>
                  <paragraph>CAUTION: Federal law restricts medicated feed containing this<br/>veterinary feed directive (VFD) drug to use by or on the order of a<br/>licensed veterinarian.</paragraph>
                  <paragraph>See mixing directions, claims, cautions and warnings on back.<br/>Restricted Drug (California) - Use Only as Directed.<br/>Not For Human Use.</paragraph>
                  <paragraph>Net wt. 50 LB (22.68 Kg)</paragraph>
                  <paragraph>Pharmgate<br/>ANIMAL HEALTH</paragraph>
                  <renderMultiMedia referencedObject="MM2"/>
               </text>
               <effectiveTime value="20231024"/>
               <component>
                  <observationMedia ID="MM2">
                     <text>PRINCIPAL DISPLAY PANEL - 22.68 Kg Bag Label</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="pennox-02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>