<?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="7128f215-03a2-494a-8600-92d06466a528"/>
   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <title>
      <content styleCode="bold">go-dry<sup>TM</sup>
      </content>
      <br/>
      <content styleCode="bold">(penicillin G procaine in sesame oil)</content>
      <br/>
      <content styleCode="bold">100,000 units/10mL Syringe</content>
      <br/>
      <content styleCode="bold">For Intramammary Infusion in Dry Cows Only</content>
      <br/>
      <content styleCode="bold">Antibacterial<br/>CAUTION: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian. <content styleCode="bold"/>
   </title>
   <effectiveTime value="20250314"/>
   <setId root="cd9c8ace-01ab-42bf-be5a-0087bf5ac5d8"/>
   <versionNumber value="3"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="117160633" root="1.3.6.1.4.1.519.1"/>
            <name>US Vet Inc</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="002238863" root="1.3.6.1.4.1.519.1"/>
                        <name>GC Hanford Manufacturing Company</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="300220969" root="1.3.6.1.4.1.519.1"/>
                        <name>Sandoz GmbH</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="API MANUFACTURE"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="1579f7bb-3852-45f8-9eea-8a640ee4cadf"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20240207"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86108-012" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>go-dry</name>
                        <formCode code="C42994" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUSPENSION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Penicillin G Procaine in Sesame Oil</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator unit="[iU]" value="100000"/>
                              <denominator unit="1" value="1"/>
                           </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>
                        <asContent>
                           <quantity>
                              <numerator unit="1" value="100000"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43202" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SYRINGE"/>
                              <asContent>
                                 <quantity>
                                    <numerator unit="1" value="12"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="86108-012-10" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43178" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOX"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA065081" 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="20201218"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C79137" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INTRAMAMMARY"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="ID_93233827-8276-474f-b842-e9a6afaa29c2">
               <id root="ccbf955b-c61d-4195-abd6-1e9b0acc943b"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION<content styleCode="italics"/>
               </title>
               <text>
                  <paragraph>Each syringe contains:<br/>100,000 units of penicillin G procaine, sesame oil 8.7g, calcium carbonate 0.089g, corn starch 0.089g, hydrogenated castor oil 0.044g.</paragraph>
               </text>
               <effectiveTime value="20240207"/>
            </section>
         </component>
         <component>
            <section ID="ID_ef847aa4-eda3-4a85-bff9-2d249c2b1a6e">
               <id root="12a44324-8137-4eb9-8318-0e57562c9bef"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS </title>
               <text>
                  <paragraph>This product is intended for the treatment of bovine mastitis in dry cows. This product is effective against udder infections caused by the following susceptible microorganism: <content styleCode="bold">
                        <content styleCode="italics">Streptococcus agalactiae.</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20240207"/>
            </section>
         </component>
         <component>
            <section ID="ID_06b96b01-06df-4be2-82fe-4f62cc39333a">
               <id root="62d45e0c-02fa-451b-936c-e146ea49149f"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>DOSAGE </title>
               <text>
                  <paragraph>Administer at the time of drying-off by infusing each quarter, one time only, with a single 10mL syringe.</paragraph>
               </text>
               <effectiveTime value="20240207"/>
            </section>
         </component>
         <component>
            <section ID="ID_1b4a7d35-9063-46ee-b322-9c5a129739e6">
               <id root="8d9a6781-d47f-44cb-8565-e6ce6a9fe50e"/>
               <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, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy disinfectant. Dry thoroughly. The hands of the operator should be washed and dried before administration of each treatment. Using the alcohol pads that are provided with each syringe wipe off teat, using a separate pad for each teat. </paragraph>
                  <paragraph>When using this product, remove plastic cover from tip of syringe and, while holding teat firmly, insert tip into streak canal, then push plunger and inject entire contents. After injection, grasp the end of the teat firmly, then gently massage the medication up the teat canal into the udder. It is recommended to use a suitable teat dip on all teats following treatment.</paragraph>
               </text>
               <effectiveTime value="20240207"/>
            </section>
         </component>
         <component>
            <section ID="ID_99479d12-24a6-44df-947c-89cb07356e78">
               <id root="4671f447-fb4f-4920-9e0b-801e4602d93b"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNING </title>
               <text>
                  <paragraph>Discard all milk for 72 hours (6 milkings) following calving or later as indicated by the marketable quality of the milk.</paragraph>
                  <paragraph>Animals intended for human consumption must not be slaughtered within 14 days of the last treatment with go-dry™.</paragraph>
                  <paragraph>Use of this product in a manner other than as directed in the labeling might result in violative residues.</paragraph>
                  <paragraph>
                     <content styleCode="bold">THIS PRODUCT WAS MANUFACTURED BY A NON-STERILIZING PROCESS.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED</content>
                  </paragraph>
               </text>
               <effectiveTime value="20240207"/>
            </section>
         </component>
         <component>
            <section ID="ID_5b4525cb-1d36-49f1-88b0-25c930bb69b4">
               <id root="bfbed038-760b-4826-b435-cfea651be06c"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS </title>
               <text>
                  <paragraph>For use in dry cows only.</paragraph>
                  <paragraph>Discard empty container. Do not reuse. </paragraph>
                  <paragraph>Not for human use.</paragraph>
                  <paragraph>Keep this and all medications out of the reach of children.</paragraph>
                  <paragraph>Shake well before using.</paragraph>
                  <paragraph>It is a violation of Federal law to use go-dry™ in food-producing animals other than as directed in the labeling.</paragraph>
               </text>
               <effectiveTime value="20240207"/>
            </section>
         </component>
         <component>
            <section ID="ID_636c0f47-5b08-46fe-affa-00247a7c9bb9">
               <id root="71c42b59-66db-42c4-9cd6-070ac206a842"/>
               <code code="54433-8" codeSystem="2.16.840.1.113883.6.1" displayName="USER SAFETY WARNINGS SECTION"/>
               <title>USER SAFETY WARNINGS </title>
               <text>
                  <paragraph>Penicillins can cause allergic reactions in sensitized individuals. Topical exposure to penicillin may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing.</paragraph>
                  <paragraph>Persons with known hypersensitivity to penicillin should avoid exposure to this product.</paragraph>
                  <paragraph>In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.</paragraph>
                  <paragraph>The material safety data sheet contains more detailed occupational safety information.</paragraph>
                  <paragraph>To report side effects in users, to obtain more information or to obtain a Material Safety Data Sheet, call 1-866-562-4708.</paragraph>
                  <paragraph>
                     <content styleCode="bold">STORE AT CONTROLLED ROOM TEMPERATURE: 20˚ - 25˚C (68˚-77˚F).</content>
                  </paragraph>
                  <paragraph>Manufactured for:<br/>
                     <content styleCode="bold">US VET Inc.</content>
                     <br/>Liverpool, NY 13088</paragraph>
                  <paragraph>Approved by FDA under NADA # 065-081</paragraph>
                  <paragraph>INS12DC879 13               Rev. 08/2024</paragraph>
               </text>
               <effectiveTime value="20250314"/>
            </section>
         </component>
         <component>
            <section ID="ID_42c34505-b8a5-4380-94d4-1ee916169704">
               <id root="64314449-c5ef-49ec-9960-4060617ad0c0"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PACKAGE/LABEL PRINCIPAL DISPLAY PANEL </title>
               <text>
                  <renderMultiMedia ID="id-1794742606" referencedObject="ID_2857291f-28ae-42c0-8289-328e56828b87"/>
                  <paragraph>NDC 86108-012-10 </paragraph>
                  <paragraph>go-dry<sup>TM</sup>
                  </paragraph>
                  <paragraph>Penicillin G Procaine in Sesame Oil </paragraph>
                  <paragraph>100,000 units/10mL Syringe<br/>For Intramammary Infusion in Dry Cows Only<br/>Antibacterial</paragraph>
               </text>
               <effectiveTime value="20250314"/>
               <component>
                  <observationMedia ID="ID_2857291f-28ae-42c0-8289-328e56828b87">
                     <text>Go Dry Label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="image-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>