<text/> <effectiveTime value="20220523"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="11695-6979" codeSystem="2.16.840.1.113883.6.69"/> <name>CeraSoothe<suffix>KET</suffix> </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="1" unit="mg"/> <denominator value="1" 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 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<name>GLYCERIN</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="5THT33P7X7" codeSystem="2.16.840.1.113883.4.9"/> <name>CERAMIDE 1</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="CR0J8RN66K" codeSystem="2.16.840.1.113883.4.9"/> <name>CERAMIDE EOS</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="1VPU26JZZ4" codeSystem="2.16.840.1.113883.4.9"/> <name>POTASSIUM SORBATE</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="229D0E1QFA" codeSystem="2.16.840.1.113883.4.9"/> <name>METHYLISOTHIAZOLINONE</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="118" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="11695-6979-1" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43173" displayName="BOTTLE, PLASTIC" 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="11695-6979-2" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43173" displayName="BOTTLE, PLASTIC" 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="20210402"/> </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="Lb392156a-b60d-4005-9123-8b2638fb622a"> <id root="f694cafe-25ed-44c2-986f-37d832d7bddc"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <text> <paragraph> <content styleCode="bold">CeraSoothe KET </content> </paragraph> <paragraph> <content styleCode="bold">Antiseptic Flush</content> </paragraph> <paragraph> <content styleCode="bold">Fragrance free</content> </paragraph> <paragraph>Ketoconazole 0.1%</paragraph> <paragraph>Formulated for cats and dogs</paragraph> <paragraph> <content styleCode="bold">Keep out of reach of children</content> </paragraph> <paragraph>For animal use only</paragraph> <paragraph>A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. Tromethamine (TRIS) helps break down bacteria cell walls. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.</paragraph> <paragraph> <content styleCode="bold">Active ingredients:</content> Ketoconazole 0.1%.</paragraph> <paragraph> <content styleCode="bold">Inactive ingredients:</content> Water, SD Alcohol 40-B, nonoxynol-9, disodium EDTA, tromethamine, avena sativa (oat) kernal extract, glycerin, ceramide EOP, ceramide EOS, ceramide NP, potassium sorbate, methylisothiazolinone.</paragraph> </text> <effectiveTime value="20220523"/> </section> </component> <component> <section ID="L6bc9a74f-6bc7-4ae5-bbfd-74c268e7cf94"> <id root="d53e0691-1c49-4bcc-829e-96a60dcb9020"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">Indications:</content> For use on cats and dogs for the antiseptic cleansing of skin and ears.</paragraph> <paragraph> <content styleCode="bold">Directions for use:</content> Apply twice a day or as directed by your veterinarian. Wash hands after use.</paragraph> <paragraph> <content styleCode="underline"/> </paragraph> <paragraph> <content styleCode="underline">Ear cleaning:</content> Moisten a cotton ball with solution and place in entrance of ear canal, or hold the ear flap upwards and fill the ear canal with solution. Then, gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball.</paragraph> <paragraph> <content styleCode="underline">Skin cleaning:</content> Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean. </paragraph> </text> <effectiveTime value="20210331"/> </section> </component> <component> <section ID="Lfad0b7c5-b430-49db-a6a6-17434fa5c1bf"> <id root="f8ba5f07-d847-4ed2-a310-f91c6481bf70"/> <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">Cautions:</content> For external use on dogs or cats only. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use in the case of a suspected ruptured eardrum.</paragraph> </text> <effectiveTime value="20210331"/> </section> </component> <component> <section ID="Laea365ab-9b27-4091-864e-3745b63a6eda"> <id root="62b2d6e1-a2fc-4485-bee6-9c5e977a139f"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph> <content styleCode="bold">Storage:</content> Store at room temperature. Do not freeze.</paragraph> </text> <effectiveTime value="20210331"/> </section> </component> <component> <section ID="L71ff7081-3672-47ba-9380-b66089b63ab6"> <id root="55e4de9f-a817-4303-a592-60f2250090cc"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">Questions?</content> </paragraph> <paragraph>(855) 724-3461</paragraph> <paragraph>Distributed by:<br/>Covetrus North America<br/>Dublin, OH 43017<br/> <content styleCode="bold">covetrus.com</content> </paragraph> </text> <effectiveTime value="20210331"/> </section> </component> <component> <section ID="L51cb2242-a221-4293-8720-e415a0796c06"> <id root="a1aee533-65b0-4b53-aff7-adfb1cb13a0f"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle Inspired by veterinarians CeraSoothe KET Antiseptic Flush Fragrance free Ketoconazole 0.1%,  Formulated for cats and dogs Keep out of reach of children For animal use only NDC 11695-6979-1 Net contents: 4 fl oz (118 mL) 4 ounce bottle label
PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle Inspired by veterinarians CeraSoothe KET Antiseptic Flush Fragrance free Ketoconazole 0.1%, Formulated for cats and dogs Keep out of reach of children For animal use only NDC 11695-6979-2 Net contents: 16 fl oz (473 mL) image description