<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet type="text/xsl" href="https://www.accessdata.fda.gov/spl/stylesheet/spl.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="fdf35f2e-3f20-467c-a411-d2b8e98cae92"/>
   <code code="50578-4" displayName="PRESCRIPTION ANIMAL DRUG LABEL" codeSystem="2.16.840.1.113883.6.1"/>
   <title>Albadry Plus®</title>
   <effectiveTime value="20230608"/>
   <setId root="049b289b-3813-4d06-90d7-0d31c0b34977"/>
   <versionNumber value="6"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="828851555" root="1.3.6.1.4.1.519.1"/>
            <name>Zoetis Inc.</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="135fd6d6-d40d-4d14-ae57-91b130008066"/>
               <code code="48780-1" displayName="SPL listing data elements section" codeSystem="2.16.840.1.113883.6.1"/>
               <effectiveTime value="20230608"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="54771-3139" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Albadry Plus</name>
                        <formCode code="C42945" displayName="INJECTION, SOLUTION" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>novobiocin sodium and penicillin G procaine</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator unit="mg" value="400"/>
                              <denominator unit="mL" value="10"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="Q9S9NQ5YIY" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>NOVOBIOCIN SODIUM</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="17EC19951N" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>NOVOBIOCIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator unit="[iU]" value="200000"/>
                              <denominator unit="mL" value="10"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="17R794ESYN" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PENICILLIN G PROCAINE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="Q42T66VG0C" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PENICILLIN G</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <quantity>
                              <numerator unit="mg" value="50"/>
                              <denominator unit="mL" value="10"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="HM4YQM8WRC" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CHLOROBUTANOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="10"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="54771-3139-9" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43202" displayName="SYRINGE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <asContent>
                                 <quantity>
                                    <numerator unit="1" value="12"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="54771-3139-1" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="10"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="54771-3139-9" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43202" displayName="SYRINGE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <asContent>
                                 <quantity>
                                    <numerator unit="1" value="144"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="54771-3139-2" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C79136" displayName="PAIL" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA055098" root="2.16.840.1.113883.3.150"/>
                           <code code="C73593" displayName="NADA" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <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="19830107"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C79137" displayName="INTRAMAMMARY" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="LINK_87e2d98c-6d19-4219-9e2b-e1614f47ccd2">
               <id root="c184548d-511d-4d5d-aa59-4c0c362f02fb"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Albadry Plus®<br/>(penicillin G procaine and novobiocin sodium intramammary infusion)<br/>
                        <br/>For the Treatment of Subclinical Mastitis in Dry Cows<br/>For Udder Instillation in Dry Cows Only<br/>FOR USE IN ANIMALS ONLY—NOT FOR HUMAN USE</content>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_d4829ec3-07d0-45b2-ab88-014ed7583992">
               <id root="3a3133d9-b219-4485-bf84-f1a52b7b5a8c"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>CAUTION</title>
               <text>
                  <paragraph>Federal law restricts this drug to use by or on the order of a licensed veterinarian.<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_0c8d33f9-5ef2-4973-8aab-c5aa7c1af7b8">
               <id root="a4516009-e901-40e4-b6c5-15c67604bd4f"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION</title>
               <text>
                  <table>
                     <col/>
                     <col/>
                     <thead>
                        <tr>
                           <th colspan="2"> Each 10 mL PLASTET<sup>®</sup> Disposable Syringe contains:</th>
                        </tr>
                     </thead>
                     <tbody>
                        <tr>
                           <td> Novobiocin sodium equiv. to novobiocin</td>
                           <td align="right"> 400 mg</td>
                        </tr>
                        <tr>
                           <td> Penicillin G procaine</td>
                           <td align="right"> 200,000 IU</td>
                        </tr>
                        <tr>
                           <td> Chlorobutanol anhydrous<br/>(chloral derivative—used as a preservative)<br/>in a special bland vehicle</td>
                           <td align="right"> 50 mg</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>Manufactured by a non-sterilizing process.</paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_fbd33ced-6a67-47fa-86cf-552d54e1ddfd">
               <id root="03ee2294-cf34-4c1c-bbcf-c6db5285362e"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS FOR USE</title>
               <text>
                  <paragraph>ALBADRY PLUS Suspension is indicated for the treatment, in dry cows only, of subclinical mastitis caused by susceptible strains of <content styleCode="italics">Staphylococcus aureus and Streptococcus agalactiae.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_16219601-e34b-4909-ac29-737bcc0a9aa9">
               <id root="148f0894-dbad-448a-a269-8c2dfaca2917"/>
               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <title>WARNINGS</title>
               <text>
                  <paragraph>1. Do not use less than 30 days prior to calving.</paragraph>
                  <paragraph>2. Milk from treated cows must not be used for food during the first 72 hours after calving.</paragraph>
                  <paragraph>3. Treated animals must not be slaughtered for food for 30 days following udder infusion.</paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_06ea5fcd-37e5-4834-a3e6-e259d9a0a8ad">
               <id root="d8913261-418f-4d1c-83a7-e879fa6d6dbb"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTION</title>
               <text>
                  <paragraph>Administration of this product in any manner other than shown under DOSAGE may result in drug residues.</paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_026e25d2-91b5-4738-836a-c5a3f6375a7a">
               <id root="5848aaf6-4aab-41f7-9025-baa07e26bf5d"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE</title>
               <text>
                  <paragraph>Infuse one tube per quarter at start of dry period (but not less than 30 days prior to calving).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Shake Well Before Using</content>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_f9a111dd-3390-4d51-b4c5-a2872422a763">
               <id root="0722b541-b2f7-483b-bad8-6da622bd955e"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS FOR USING THE FLEXI-TUBE® SYSTEM</title>
               <text>
                  <paragraph>The FLEXI-TUBE is designed to provide the choice of either insertion of the full cannula, as has traditionally been practiced, or insertion of no more than ⅛ inch of the cannula, as recommended by the National Mastitis Council.</paragraph>
                  <list listType="unordered" styleCode="Disk">
                     <item>
                        <content styleCode="bold">Full Insertion: </content>Remove the blue end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product.<list listType="unordered" styleCode="Circle">
                           <item>
                              <renderMultiMedia referencedObject="MM1"/>
                           </item>
                        </list>
                     </item>
                     <item>
                        <content styleCode="bold">Partial Insertion: </content>Remove <content styleCode="italics">both</content> the blue end cap and the red cannula by pushing sideways as shown. Gently insert the exposed blue tip into the teat canal; carefully infuse the product.<list listType="unordered" styleCode="Circle">
                           <item>
                              <renderMultiMedia referencedObject="MM2"/>
                           </item>
                        </list>
                     </item>
                  </list>
               </text>
               <effectiveTime value="20230608"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>Figure a.</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="albadry-plus-1.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="MM2">
                     <text>Figure b.</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="albadry-plus-2.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="LINK_f3ced8fd-149c-421c-bab9-74b83792ad5c">
               <id root="82ce8d43-02c8-4810-9d7e-b9fd15fe3737"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>ADMINISTRATION</title>
               <text>
                  <paragraph>At the time of drying off, but not less than 30 days prior to calving, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy antiseptic. Dry the teats and udder thoroughly. Infuse each quarter using the following procedure. Using the alcohol pads provided, scrub each teat end clean using a separate pad for each teat. Warm ALBADRY PLUS Suspension to body temperature and shake thoroughly. Choose the desired insertion length (full or partial) and insert tip into teat canal. Instill entire contents into the quarter. Massage the udder after treatment to distribute the ALBADRY PLUS Suspension throughout the quarters. Using a suitable teat dip, dip all teats following treatment.<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_85872828-92fd-406f-9ffb-4921804fd36b">
               <id root="578e308c-7185-43ba-9523-a2a18db34c24"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <table>
                     <col width="100%"/>
                     <tbody>
                        <tr>
                           <td align="center" styleCode=" Lrule Rrule"> Discard Empty Container; DO NOT REUSE <br/>KEEP OUT OF REACH OF CHILDREN</td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_0b4393fb-60b5-42fd-a891-4cb56a19d9a2">
               <id root="2f105a67-801e-4dfa-9efe-89c3825c04ce"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>STORAGE CONDITIONS</title>
               <text>
                  <paragraph>Store at controlled room temperature 20° to 25° C (68° to 77° F).<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_413b11ff-804b-4150-9c82-34fd059281a5">
               <id root="8df99fae-0624-459b-85f0-a4707cd8c1a2"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <title>HOW SUPPLIED</title>
               <text>
                  <paragraph>ALBADRY PLUS Suspension is available in unbroken packages of 12–10 mL PLASTET Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and unbroken packages of 144–10 mL PLASTET Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.</paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_bae84541-d1d4-4538-9887-d1a092ec00a9">
               <id root="0a686ab2-8263-4ec9-9d6f-6148f097992d"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA #055-098</content>
                  </paragraph>
                  <paragraph>Distributed by:<br/>Zoetis Inc.,<br/>Kalamazoo, MI 49007<br/>Revised: June 2022<br/>
                     <br/>002544I10</paragraph>
               </text>
               <effectiveTime value="20230608"/>
            </section>
         </component>
         <component>
            <section ID="LINK_418f334f-2a94-42bc-89bc-08a44c7e9751">
               <id root="74f7837f-dd62-4f8b-ae60-9542d3744257"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="MM3"/>
                     <br/>
                  </paragraph>
               </text>
               <effectiveTime value="20230608"/>
               <component>
                  <observationMedia ID="MM3">
                     <text>10 mL Syringe Label</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="albadry-plus-3.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>