<content styleCode="bold">mysimplepetlab Infected Ear Relief</content>
<text/> <effectiveTime value="20230328"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="86166-111" codeSystem="2.16.840.1.113883.6.69"/> <name>MySimplePetLab Infected Ear Relief</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="0.1" unit="g"/> <denominator value="100" 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="LKG8494WBH" codeSystem="2.16.840.1.113883.4.9"/> <name>BENZYL ALCOHOL</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="8NLQ36F6MM" codeSystem="2.16.840.1.113883.4.9"/> <name>EDETATE DISODIUM ANHYDROUS</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="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/> <name>ALCOHOL</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="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/> <name>WATER</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="118" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="86166-111-04" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43169" displayName="BOTTLE" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> <asContent> <quantity> <numerator value="355" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="86166-111-12" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43169" displayName="BOTTLE" 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="20230201"/> </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="L28cb312d-188b-4085-b36c-fccbb2d905ef"> <id root="41b89845-4260-4489-a7da-51c0aa85597b"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title> <content styleCode="italics">Drug Facts</content>
<content styleCode="italics">Active ingredient</content> Ketoconazole 0.1%
<content styleCode="italics">Purpose</content> Antifungal
<content styleCode="italics">Uses</content> • antiseptic (antifungal) solution for gentle cleansing and flushing of ears and skin • contains ketoconazole for the management of fungal activity.
<content styleCode="italics">Warnings</content> For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Consult your veterinarian and discontinue use if undue skin irritation develops or increases. Keep out of the reach of children.
<content styleCode="italics">Directions</content> • shake well before use • apply liberally to the affected area(s) • apply twice daily or as directed by veterinarian • use cotton or absorbent material to clean excess solution and wipe away debris • do not allow the animal to lick the treated area until dry to prevent ingestion • wash hands after use.
<content styleCode="italics">Other information</content> Store at controlled room temperature.
<content styleCode="italics">Inactive ingredients</content> Benzyl Alcohol, Disodium EDTA, Fragrance, Nonoxynol-9, SD Alcohol 40-B, Tromethamine, Water.
<text> <paragraph>Vet Approved Pet Care From Home</paragraph> <paragraph> <content styleCode="bold">Medicated Tris Flush</content> </paragraph> <paragraph> <content styleCode="bold">Topical Antiseptic Solution For Cleansing & Flushing Of Ears</content> </paragraph> <paragraph> <content styleCode="bold">Formulated For Dogs</content> </paragraph> <paragraph> <content styleCode="bold">Cucumber Melon Scent</content> </paragraph> <paragraph> <content styleCode="bold">MADE IN THE USA</content> </paragraph> <paragraph>FORMULATED FOR VETERINARIANS | WITH GLOBALLY SOURCED INGREDIENTS</paragraph> <paragraph>Distributed by:<br/>MySimplePetLab Inc.<br/>Denver, CO 80223<br/>833-738-8378<br/>www.MySimplePetLab.com</paragraph> </text> <effectiveTime value="20230320"/> </section> </component> <component> <section ID="Ld9dff4db-ce68-421a-9f6a-c0537df53fd8"> <id root="5790af44-091c-4ddc-aff9-97695d0f442a"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>Packaging InfectedEarRelief-111