Forticept Antiseptic Ear Flush - Medicated Otic Cleanser
<text/> <effectiveTime value="20220815"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="72127-0904" codeSystem="2.16.840.1.113883.6.69"/> <name>Forticept Antiseptic Ear Flush</name> <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/> <asEntityWithGeneric> <genericMedicine> <name>Ketoconazole</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="2" unit="g"/> <denominator value="1000" unit="g"/> </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="7T1F30V5YH" codeSystem="2.16.840.1.113883.4.9"/> <name>POLYSORBATE 20</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/> <name>PROPYLENE GLYCOL</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="ZY81Z83H0X" codeSystem="2.16.840.1.113883.4.9"/> <name>ALOE VERA LEAF</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="A1A1I8X02B" codeSystem="2.16.840.1.113883.4.9"/> <name>DIETHYLENE GLYCOL MONOETHYL ETHER</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/> <name>GLYCERIN</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="33X04XA5AT" codeSystem="2.16.840.1.113883.4.9"/> <name>LACTIC ACID</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="R57ZHV85D4" codeSystem="2.16.840.1.113883.4.9"/> <name>BORIC ACID</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="P0M7O4Y7YD" codeSystem="2.16.840.1.113883.4.9"/> <name>CALENDULA OFFICINALIS FLOWER</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="237" unit="g"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="72127-0904-1" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43170" displayName="BOTTLE, DISPENSING" 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="20220818"/> </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="L2cf80f47-11f6-48ac-96e0-cd821cf585a8"> <id root="e45bef9f-4b53-4ae4-875b-6c54c6bcfe2c"/> <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/> <title>Active Ingredient(s): Ketoconazole.......0.2% (Antifungal)
<content styleCode="italics">Indications:</content> Medicated cleansing and flushing solution to support topical conditions responsive to Ketoconazole.
<content styleCode="italics">Warnings:</content> For external use only / Not for human use
Keep out of reach of children
When using this product - Avoid contact with eyes and mucous membranes.
Stop use and ask a veterinarian if condition worsens, or irritation occurs.
<content styleCode="italics">Directions:</content> For use on ears: apply solution to the ear canal and with firm but gentle pressure, massage the base of the ear.
Use an absorbent material to clean any 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">Storage:</content> Store at room temperature - 68F to 77F (20°C-25°C)
Protect from freezing or excessive heat
<content styleCode="italics">First Aid:</content> If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use, and if irritation persists, contact a veterinarian.
If large quantities of this material are swallowed, contact poison control center immediately!
<content styleCode="italics">Inactive ingredients:</content> Water, Polysorbate 20, Propylene Glycol, Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Glycerin, Lactic Acid, Benzyl Alcohol, Boric Acid, Calendula Officinalis
8oz Amazon label 8oz label