<content styleCode="bold">Keto-C<sup>®</sup>-Tris WIPES</content>


               
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                        <code code="86069-116" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Keto-C-Tris WIPES</name>
                        <formCode code="C60884" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CLOTH"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Ketoconazole</name>
                           </genericMedicine>
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                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="0.1" unit="g"/>
                              <denominator value="100" unit="g"/>
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                           <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>
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                        </ingredient>
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                           <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>
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                              <code code="8NLQ36F6MM" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>EDETATE DISODIUM ANHYDROUS</name>
                           </ingredientSubstance>
                        </ingredient>
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                           <ingredientSubstance>
                              <code code="LKG8494WBH" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>BENZYL ALCOHOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="023C2WHX2V" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TROMETHAMINE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="0.1" unit="g"/>
                              <denominator value="1" unit="1"/>
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                           <containerPackagedProduct>
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                                    <denominator value="1" unit="1"/>
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                                    <formCode code="C43186" displayName="CONTAINER" codeSystem="2.16.840.1.113883.3.26.1.1"/>
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                        <marketingAct>
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                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20210324"/>
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                     <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>
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                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
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            </section>
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               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Active Ingredients:</content> Ketoconazole 0.1%.</paragraph>
               </text>
               <effectiveTime value="20221122"/>
            </section>
         </component>
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               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <text>
                  <paragraph>anti-fungal</paragraph>
               </text>
               <effectiveTime value="20221207"/>
            </section>
         </component>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/>
               <text>
                  <paragraph>Keto-C<sup>® </sup>Tris Wipes is an antiseptic (anti-fungal) solution for gentle cleansing of ears and skin. Contains Ketoconazole for the management of fungal activity. Can be used on dogs and cats.</paragraph>
               </text>
               <effectiveTime value="20221122"/>
            </section>
         </component>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Inactive Ingredients: </content>Water, SD Alcohol-40B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine Technical Grade.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Instructions: </content>Gently rub accessible portion of ear with wipe. Repeat with another clean pad until pad is free of debris. Use daily to maintain healthy clean ears. Safe for dogs and cats over 12 weeks of age. For topical use only within the ears.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Storage</content>: Store at controlled room temperature.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Cautions</content>: For topical use in animals only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.</paragraph>
               </text>
               <effectiveTime value="20221122"/>
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         <component>
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               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Keep out of the reach of children.</content>
                  </paragraph>
               </text>
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         <component>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>ANTISEPTIC & NON-IRRITATING</paragraph>
                  <paragraph>FOR DOGS & CATS</paragraph>
                  <paragraph>
                     <content styleCode="bold">CUCUMBER MELON SCENT</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Stratford Animal Care</content>
                     <br/>A MEMBER OF THE SWEDENCARE FAMILY</paragraph>
                  <paragraph>Distributed by: StratfordCare USA<br/>Odessa, FL 33556. 877-498-2002<br/>www.stratfordrx.com</paragraph>
               </text>
               <effectiveTime value="20221207"/>
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               <title>Packaging
               
                  
                     
                  
               
               
               
                  
                     Keto-C-116