<?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="c689e40e-f663-48b6-a206-9d3430e450e8"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Pi<content styleCode="italics">vet</content>al<sub>®</sub> Suffusion™ Tris ANTISEPTIC FLUSH</title>
   <effectiveTime value="20260415"/>
   <setId root="bf0f6056-a94f-4ca1-8e7c-cfa2545d5d70"/>
   <versionNumber value="2"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="627265361"/>
            <name>ASPEN VETERINARY RESOURCES</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="a3480a20-3210-4a3a-befa-35d726846119"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20260415"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="46066-079" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Suffusion<suffix>TRIS</suffix>
                        </name>
                        <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SOLUTION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>ketoconazole</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="1" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="R9400W927I" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>KETOCONAZOLE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="R9400W927I" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>KETOCONAZOLE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>WATER</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ALCOHOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="48Q180SH9T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>NONOXYNOL-9</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="7FLD91C86K" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>EDETATE DISODIUM</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="023C2WHX2V" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TROMETHAMINE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="229D0E1QFA" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHYLISOTHIAZOLINONE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="4370DF050B" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CERAMIDE NP</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="F1X8L2B00J" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CERAMIDE AP</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="GIN46U9Q2Q" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PHYTOSPHINGOSINE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="Z6J799EAJK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>OAT</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="5THT33P7X7" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CERAMIDE 1</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="118" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="46066-079-88" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" displayName="BOTTLE, PLASTIC" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="473" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="46066-079-91" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" displayName="BOTTLE, PLASTIC" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20210402"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <code code="C73627" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="unapproved drug other"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="L33a64d0b-a4b9-429e-ab8b-ad09385497f2">
               <id root="11877be4-ed1c-4f39-9192-85e54658186f"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>ACTIVE INGREDIENT:</title>
               <text>
                  <paragraph>Ketoconazole 0.1%.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L8f51a58e-bf98-471d-9130-cc6d38a44fbf">
               <id root="921750f9-8240-4854-bccb-df982064d950"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>INACTIVE INGREDIENTS: </title>
               <text>
                  <paragraph>Water, SD Alcohol 40-B , Nonoxynol-9, Disodium EDTA, Tromethamine, Methylisothiazolinone, Ceramide NP, Ceramide AP, Phytosphingosine, Avena sativa (Oat) Kernel Extract, Ceramide EOP.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L8c3f50ea-cebc-47bc-89c3-eaf25cb0b8b9">
               <id root="1b1b560e-612c-4a1d-bbfc-4f5405248110"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>PROPERTIES:</title>
               <text>
                  <paragraph>A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. Suffusion™ Tris helps break down bacteria cell walls. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L747f351b-3603-4e75-9a4e-a42867b63851">
               <id root="26b7a2ca-9a92-44b0-975c-d05c4a19695d"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS:</title>
               <text>
                  <paragraph>For use on dogs and cats for the antiseptic cleansing of skin and ears.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L79b0cecf-9636-4b7a-9b27-9c17a2cef0c8">
               <id root="244364e1-2f6a-4df6-8495-f3eeffc1e778"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>CAUTIONS:</title>
               <text>
                  <paragraph>For external use on dogs and cats only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use with a suspected ruptured eardrum as directed by your veterinarian.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="Ldc07b624-dfc6-4f70-93bf-87cf05d53a02">
               <id root="fdad7415-93f3-4fd4-abce-e845a2519016"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS FOR USE:</title>
               <text>
                  <paragraph>
                     <content styleCode="underline">Skin Cleaning</content>: Apply twice a day or as directed by your veterinarian. Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean. Wash hands after use.</paragraph>
                  <paragraph>
                     <content styleCode="underline">Ear Cleaning</content>: Ask your veterinarian which of these protocols is best for your pet: <br/>1) Moisten a cotton ball with solution and place in the entrance of the ear canal; OR <br/>2) Hold ear flap upward and fill with solution as directed by your veterinarian. <br/>Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and excess solution with a clean cotton ball. Wash hands after use.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L3d817bb2-ccf7-478b-b614-c600f2a8ebb5">
               <id root="4838e376-9a0e-4e9b-83b3-abf57176bb00"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNING:</title>
               <text>
                  <paragraph>Not for human use. Keep out of reach of children.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="Ld2952868-27ec-4200-b078-a2bf464dbf09">
               <id root="26909988-4bfd-4f10-8f40-8d8b22440491"/>
               <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 room temperature. Do not freeze.</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L89e0d27c-0d9d-4ca5-a757-1dbae3d3b1cb">
               <id root="952a3b9d-7167-40b7-830b-b8e8a5e45cae"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>QUESTIONS?</title>
               <text>
                  <paragraph>info@aspenveterinaryresources.com</paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="L2e3fd254-c696-439b-bc22-3710d3d11bcd">
               <id root="83812950-e2ac-488d-8219-7d97ebd3075a"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR DOGS &amp; CATS</content>
                  </paragraph>
                  <paragraph>BREAKS DOWN<br/>BACTERIA</paragraph>
                  <paragraph>Manufactured for:<br/>Aspen Veterinary Resources<sup>®</sup>, LTD.<br/>Liberty, MO 64068</paragraph>
                  <paragraph>
                     <content styleCode="bold">pivetalvet.com</content>
                  </paragraph>
               </text>
               <effectiveTime value="20260415"/>
            </section>
         </component>
         <component>
            <section ID="Lcbd973d0-7db4-400f-9bee-879a77cf0481">
               <id root="2f13c002-d9ac-4277-a5bf-81f97cfbbdbe"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Packaging</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L4c222599-b355-4a5f-b56e-6e88c51b0185"/>
                  </paragraph>
               </text>
               <effectiveTime value="20260415"/>
               <component>
                  <observationMedia ID="L4c222599-b355-4a5f-b56e-6e88c51b0185">
                     <text>Suffusion</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="46066079-1.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>