STRATFORD Keto-C<sup>®</sup> TRIS FLUSH WITH CeraGuard™
<text/> <effectiveTime value="20260216"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="86069-141" codeSystem="2.16.840.1.113883.6.69"/> <name>STRATFORD Keto-C TRIS FLUSH WITH CeraGuard</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="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="88KCS7120E" codeSystem="2.16.840.1.113883.4.9"/> <name>CERAMIDE 9</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="118" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="86069-141-02" 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="473" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="86069-141-06" 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="20260210"/> </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> <consumedIn> <substanceAdministration> <routeCode code="C38192" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="AURICULAR (OTIC)"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="L3121ec21-5f2a-4218-bfd2-b602a79e1dd9"> <id root="fc4a3992-86c6-4754-9046-d6a2eb5de1cc"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title/> <text> <paragraph>Keto-C<sup>®</sup> Tris Flush with CeraGuard™ contains TRIS and Ketoconazole for broad-spectrum cleansing to help manage bacteria and yeast in the ears or on the skin and coat.</paragraph> <paragraph>Specially formulated with CeraGuard™, a skin-identical lipid concentrate containing a proprietary blend of Ceramides, Phytosphingosine, Cholesterol and Avenanthramides, to support and restore the skin's natural barrier.</paragraph> <paragraph>This flush helps lock in moisture and is ideal for pets needing both antimicrobial care and skin barrier support in the ears.</paragraph> </text> <effectiveTime value="20260205"/> </section> </component> <component> <section ID="Ld0d3ef07-b5ee-478b-858c-9457f2412365"> <id root="38aae3c1-5907-477b-9d2d-966cd0082de5"/> <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/> <title>Active Ingredients: Ketoconazole 0.1%
Inactive Ingredients: Water, SD Alcohol 40-B, Nonoxynol-9, Disodium EDTA, Tromethamine, Methylisothiazolinone, Ceramide NP, Ceramide AP, Phytosphingosine, Avena sativa (Oat) Kernel Extract, Ceramide EOP.
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 to prevent ingestion. Wash hands after use.
Cautions: For animal 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.
Storage: Store at controlled room temperature.
<text> <paragraph>CERAMIDES, PHYTOSPHINGOSINE & AVENANTHRAMIDES</paragraph> <paragraph>SOLUTION FOR BARRIER REPAIR & DEEP CLEANSING ANTISEPTIC</paragraph> <paragraph>FOR DOGS, CATS & HORSES</paragraph> <paragraph> <content styleCode="bold">ANTIMICROBIAL</content> </paragraph> <paragraph>CUCUMBER MELON SCENT</paragraph> <paragraph> <content styleCode="bold">MADE IN THE USA</content> <br/>GLOBALLY SOURCED INGREDIENTS</paragraph> <paragraph> <content styleCode="bold">Advanced Science, Better Results!</content> </paragraph> <paragraph> <content styleCode="bold">Stratfordare Animal Care</content> <br/>A MEMBER OF THE SWEDENCARE FAMILY</paragraph> <paragraph> <content styleCode="bold">Distributed by: </content> <br/> <content styleCode="bold">Stratford Animal Care </content> <br/> <content styleCode="bold">4027 Tampa Road, </content> <br/> <content styleCode="bold">Oldsmar, FL 34677</content> <br/> <content styleCode="bold">877-498-2002</content> <br/> <content styleCode="bold">www.stratfordrx.com</content> </paragraph> </text> <effectiveTime value="20260217"/> </section> </component> <component> <section ID="L8fbf8c41-a7a3-401a-b47d-2f745ec63ff6"> <id root="f5e2414c-a1d1-478c-ac22-be9ba6e22590"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>Packaging TRIS FLUSH WITH CeraGuard