<content styleCode="bold"> <content styleCode="italics">first</content>Companion</content> <sup>®</sup> VETERINARY PRODUCTS <content styleCode="bold">TRIS FLUSH</content>
<text/> <effectiveTime value="20251014"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="46066-307" codeSystem="2.16.840.1.113883.6.69"/> <name>firstCompanion TRIS FLUSH</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="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="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="237" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="46066-307-90" 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="20250929"/> </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="C38192" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="AURICULAR (OTIC)"/> </substanceAdministration> </consumedIn> <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="L19ff52e1-3162-47f9-95c4-fc8920625123"> <id root="82fe6b74-3cee-4721-be90-b91ae3c831e9"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>INGREDIENTS:
Active Ingredients Ketoconazole 0.1%
Inactive Ingredients Water, SD Alcohol-40B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine Technical Grade.
CAUTIONS: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.
This product is not intended to diagnose, treat, cure, or prevent any disease.
DIRECTIONS FOR USE: 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.
STORAGE: Store at controlled room temperature.
<text> <paragraph>Solution for Cleansing and Flushing of Ears and Skin</paragraph> <paragraph> <content styleCode="bold">Formulated for Dogs and Cats</content> </paragraph> <paragraph> <content styleCode="bold">CUCUMBER <br/>MELON</content> </paragraph> <paragraph> <content styleCode="bold">TAKE TIME   </content> </paragraph> <paragraph> <content styleCode="bold">OBSERVE LABEL DIRECTIONS</content> </paragraph> <paragraph>First Companion<sup>®</sup> Tris Flush is an antiseptic solution for gentle cleansing and flushing of ears and skin. Contains Ketoconazole for the management of fungal activity. Can be used on dogs and cats.</paragraph> <paragraph> <content styleCode="bold">Manufactured for:</content> <br/>Aspen Veterinary Resources<sup>®</sup>, LTD.<br/>Liberty, MO 64068, USA</paragraph> <paragraph> <content styleCode="bold">firstcompanion.com</content> </paragraph> <paragraph> <content styleCode="bold">MADE IN THE USA</content> </paragraph> </text> <effectiveTime value="20251009"/> </section> </component> <component> <section ID="Lf9be1520-b6b7-41ba-a428-9b22dfb76f41"> <id root="bf24cd61-d0ae-4c53-8d18-71847f455f2e"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>Packaging firstCompanion TRIS FLUSH