<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:v="http://validator.pragmaticdata.com/result" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="de1fa202-a071-4eb3-afa2-b4f4a9b76f74"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Drug Facts</title>
   <effectiveTime value="20121109"/>
   <setId root="57c44635-6859-4164-a979-b52f5b5ba946"/>
   <versionNumber value="2"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="018950611" root="1.3.6.1.4.1.519.1"/>
            <name>Aidance Skincare &amp; Topical Solutions, LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="018950611" root="1.3.6.1.4.1.519.1"/>
                        <name>Aidance Skincare &amp; Topical Solutions, LLC</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="manufacture"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84732" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="label"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="075295246"/>
                        <name>Spectrum Laboratory Products, Inc</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" displayName="api manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="8b53c42b-1030-4f71-bb24-8aa7f3cc0101"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Ingredient</title>
               <text>
                  <paragraph>Clotrimazole 1.0%</paragraph>
               </text>
               <effectiveTime value="20121018"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ca0d96fa-64db-43f9-8ff9-865f248d95ca"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL listing data elements section"/>
               <effectiveTime value="20121018"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="24909-806" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Aardora Anti-Fungal<suffix>Maximum Strength</suffix>
                        </name>
                        <formCode code="C42966" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OINTMENT"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Clotrimazole</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="1.0" unit="g"/>
                              <denominator value="100" unit="g"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="G07GZ97H65" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CLOTRIMAZOLE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="G07GZ97H65" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>CLOTRIMAZOLE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="A3N5ZCN45C" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>BENTONITE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="724GKU717M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>JOJOBA OIL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="3A3U0GI71G" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MAGNESIUM OXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="AV092KU4JH" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PEPPERMINT OIL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="897WUN6G6T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SILVER OXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="VIF565UC2G" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TEA TREE OIL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="7G1J5DA97F" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>WHITE WAX</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="SOI2LOH54Z" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ZINC OXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="100" unit="g"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="24909-806-10" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="JAR"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20121018"/>
                           </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 root="9a304279-de2b-48da-bbf4-901f9ee99eb7"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>Antifungal<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20121018"/>
            </section>
         </component>
         <component>
            <section>
               <id root="1247fdd4-a0cc-488c-8838-1a444524d77e"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses</title>
               <text>
                  <list listType="unordered" ID="i2c818a3b-bb79-4829-8847-28f99432ed4d">
                     <item>Cures most fungal skin infections, including all types of ringworm.</item>
                     <item>For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.</item>
                  </list>
               </text>
               <effectiveTime value="20121018"/>
            </section>
         </component>
         <component>
            <section>
               <id root="1e705ead-0c3b-4823-ac73-045a1fd14586"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">For veterinary external use only. </content>Avoid contact with the eyes. If irritation occurs or if there is no improvement withing 4 weeks, discontinue use and consult a veterinarian.<content styleCode="bold"/>
                  </paragraph>
               </text>
               <effectiveTime value="20121018"/>
               <component>
                  <section>
                     <id root="daef56c9-a6f4-4c8d-8d34-c337b82e1c00"/>
                     <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
                     <title>Keep out of reach of children.</title>
                     <text>
                        <paragraph>If swallowed, call poison control or seek medical help.<br/>
                        </paragraph>
                     </text>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="dde4de07-849b-40f1-ac0b-2bb04f33cb6c"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <paragraph>Wash and dry affected area. Shave hair as needed to expose skin. Apply a thin layer of ointment over the affected area twice daily (morning and night) or as directed by a veterinarian. Store at room temperature.</paragraph>
               </text>
               <effectiveTime value="20121018"/>
            </section>
         </component>
         <component>
            <section>
               <id root="80646634-d55d-478a-865d-da33c8ac013f"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive Ingredients</title>
               <text>
                  <paragraph>bentonite, cera alba (organic beeswax), magnesium oxide, melaleuca alternifolia (tea tree) oil, mentha piperita (peppermint) oil, silver oxide, simmondsia chinensis (jojoba) seed oil, zinc oxide</paragraph>
               </text>
               <effectiveTime value="20121018"/>
            </section>
         </component>
         <component>
            <section>
               <id root="d3aae103-2bb5-4ace-aa9f-855ffbdb280a"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph/>
                  <paragraph/>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Questions?</content> 401-228-9802</paragraph>
                  <paragraph/>
                  <paragraph/>
                  <paragraph/>
                  <paragraph>Aardora Anti-Fungal Ointment results from 10-years of research with natural ingredients and the company's patented mineral technologies. Use anywhere on the animal's body to quickly eliminate the fungal infection and related symptoms, including itching, scaling, burning, discoloration, and soreness.<br/>
                     <br/>Made in USA. Distributed by Aardora Veterinary Health, division of Aidance Skincare &amp; Topical Solutions, LLC., Woonsocket, RI 02895.<br/>(1) 401-228-9802 www.aardora.com<br/>Protected by US and international patents granted and pending. Aardora™ and Faster Healing from Head to Tail™ are trademarks of Aardora Veterinary Health. Copyright (C) 2012 Aardora Veterinary Health. All rights reserved.</paragraph>
               </text>
               <effectiveTime value="20121109"/>
            </section>
         </component>
         <component>
            <section>
               <id root="fae38f54-3e7d-4281-a8e5-742d24eb4bbf"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 100g Jar</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Aardora</content>
                     <br/>
                     <content styleCode="bold">Maximum Strength</content>
                     <br/>All-Natural and Patented</paragraph>
                  <paragraph>
                     <content styleCode="bold">Anti-Fungal Ointment</content>
                     <br/>Faster Healing from Head to Tail™</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="MM1"/>
                  </paragraph>
               </text>
               <effectiveTime value="20121109"/>
               <component>
                  <observationMedia classCode="OBS" moodCode="EVN" ID="MM1">
                     <text>Label Image</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="Aardora_AF_100g_110712.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>