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   <title>
      <content styleCode="bold"> </content>
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      <time/>
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            <name>Elanco US Inc.</name>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="58198-0513" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Component TE-200 With Tylan</name>
                        <formCode code="C42942" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="IMPLANT"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>trenbolone acetate, estradiol, tylosin tartrate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="200"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="RUD5Y4SV0S" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>trenbolone acetate</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="P53R4420TR" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>trenbolone</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="20"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="4TI98Z838E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>estradiol</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="4TI98Z838E" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>estradiol</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="29"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="5P4625C51T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>tylosin tartrate</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="YEF4JXN031" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>tylosin</name>
                                 </activeMoiety>
                              </activeMoiety>
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                        </ingredient>
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                              <numerator unit="1" value="20"/>
                              <denominator value="1"/>
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                                 <quantity>
                                    <numerator unit="1" value="1"/>
                                    <denominator value="1"/>
                                 </quantity>
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                                    <code/>
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                                    <asContent>
                                       <quantity>
                                          <numerator unit="1" value="5"/>
                                          <denominator value="1"/>
                                       </quantity>
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                                          <code code="58198-0513-1" codeSystem="2.16.840.1.113883.6.69"/>
                                          <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
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                           <author>
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                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
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                        </approval>
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                           <statusCode code="active"/>
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                              <low value="20131209"/>
                           </effectiveTime>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Component™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">TE-200 with Tylan<sup>TM</sup>
                        </content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <br/>
                     <content styleCode="bold">(trenbolone acetate and estradiol and tylosin tartrate implants)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">For Growing Beef Steers and Heifers Fed<br/>in Confinement for Slaughter</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR GROWING BEEF STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER</content>
                  </paragraph>
                  <paragraph>Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>20 dose Cartridge Belt </paragraph>
                  <paragraph>
                     <content styleCode="bold">Use with a Component Implanter</content>
                  </paragraph>
               </text>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION: </title>
               <text>
                  <paragraph>Each cartridge belt holds 20 doses of Component TE-200 with Tylan (trenbolone acetate and estradiol and tylosin tartrate implant) Implants. Each dose of 11 pellets consists of 10 pellets containing a total of 200 mg of trenbolone acetate and 20 mg estradiol plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial.</paragraph>
               </text>
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               <title>INDICATIONS FOR USE: </title>
               <text>
                  <paragraph>For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.</paragraph>
                  <paragraph>Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. </paragraph>
                  <paragraph>Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated.</paragraph>
                  <paragraph>Do not use in animals intended for subsequent breeding, or in dairy cows.</paragraph>
               </text>
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            </section>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNING: </title>
               <text>
                  <paragraph>This product is intended for use in cattle at high risk of developing ear abscesses. Not recommended for use in cattle at low risk of developing ear abscesses (e.g., dry, clean cattle). <br/>The benefit of using a cattle ear implant containing a tylosin tartrate pellet when animals receive a concomitant antimicrobial product has not been evaluated.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Withdrawal Periods and Residue Warnings <br/>
                     </content>No withdrawal period is required when used according to labeling.<br/>Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.<br/>Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.<br/>Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.</paragraph>
                  <paragraph>
                     <content styleCode="bold">USER SAFETY WARNINGS</content>
                  </paragraph>
                  <paragraph>Not for human use. Keep out of reach of children.</paragraph>
                  <paragraph>Restricted Drug (California) - use only as directed.</paragraph>
               </text>
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            </section>
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               <code code="59845-8" codeSystem="2.16.840.1.113883.6.1" displayName="INSTRUCTIONS FOR USE SECTION"/>
               <title>IMPLANTING INSTRUCTIONS:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Loading the Implanter</content>
                     <br/>Load the implanter following the instructions supplied with each implanter. </paragraph>
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               <component>
                  <section ID="s8">
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Restrain the Animal </title>
                     <text>
                        <paragraph>Speed of implantation as well as safety of handlers is best achieved by restraining animal in a squeeze chute using head restraint. When implanting horned cattle, better control is obtained with additional use of nose tongs. </paragraph>
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                     <effectiveTime value="20250114"/>
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                        <observationMedia ID="mm02">
                           <text>Figure
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Prepare the Implant Site </title>
                     <text>
                        <paragraph>Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton which has been soaked with topical germicidal solution. Follow manufacturer’s directions on germicide for correct strength and preparation of solution. Avoid getting disinfectant in animal’s eyes. </paragraph>
                     </text>
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               <component>
                  <section ID="s10">
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Where to Implant </title>
                     <text>
                        <paragraph>The full contents of one cartridge cell should be implanted beneath the skin on the back side of the middle one-third of the ear illustrated in the drawing. The implant must not be closer to the head than the edge of the auricular cartilage ring farthest from the head. The location for insertion of the needle is a point toward the tip of the ear at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear. </paragraph>
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                           <text>Figure
</text>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Insert the Needle </title>
                     <text>
                        <paragraph>With one hand firmly grasp the ear. With the other hand insert needle point through the skin and ease forward on a lateral plane until the entire length of the needle is under the skin.</paragraph>
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                           <text>Figure</text>
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                              <reference value="com0i-0003-04.jpg"/>
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                     <title>Implant the Pellets </title>
                     <text>
                        <paragraph>After inserting the needle fully in the correct implant position, squeeze the trigger fully as the needle is withdrawn from the ear. This properly deposits the implant in the needle track. This procedure should prevent breakage or crushing of pellets if otherwise forced into contact with tough fibrous-tissue underlying the skin. The length and total contact area of a single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may interfere with rates of gain. </paragraph>
                     </text>
                     <effectiveTime value="20250114"/>
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               <component>
                  <section ID="s14">
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                     <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
                     <title>Storage Conditions </title>
                     <text>
                        <paragraph>Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity. <br/>Use before the expiration date printed on the foil pouch. Discard open foil pouches. </paragraph>
                        <paragraph>Approved by FDA under ANADA # 200-346 </paragraph>
                        <paragraph>Manufactured by a non-sterilizing process.</paragraph>
                        <paragraph>Component TE-200 with Tylan (trenbolone acetate and estradiol and tylosin tartrate implants) is covered by U.S. Patent No. 5,874,098 </paragraph>
                        <paragraph>Component, Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. <br/>© 2023 Elanco or its affiliates</paragraph>
                        <paragraph>Distributed by Elanco US Inc.,<br/>Greenfield, IN 46140, USA </paragraph>
                        <paragraph>Tylosin: Product of the United Kingdom </paragraph>
                        <paragraph>
                           <content styleCode="bold">QUESTIONS/COMMENTS?</content> For a copy of the Safety Data Sheet or to report side effects, contact Elanco US, Inc. at 1-888-545-5973.<br/>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or <linkHtml href="http://www.fda.gov/reportanimalae">http://www.fda.gov/reportanimalae</linkHtml>. </paragraph>
                        <paragraph>April 2023</paragraph>
                        <paragraph>PA104026X     AH0513 </paragraph>
                     </text>
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                     <text>Figure
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               <title>Principal Display Panel – Carton Label </title>
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                     <content styleCode="bold">
                        <content styleCode="italics">Elanco™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Component™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">TE-200 with Tylan™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(trenbolone acetate and estradiol and tylosin tartrate implants)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">For Growing Beef Steers and Heifers Fed<br/>in Confinement for Slaughter</content>
                     </content>
                  </paragraph>
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               <title>Principal Display Panel – Cartridge Label </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Component™</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">TE-200 with Tylan</content>™</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(trenbolone acetate and estradiol and tylosin tartrate implants)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Growing Beef Steers and Heifers Fed<br/>in Confinement for Slaughter</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">One 20-Dose</content>
                     <br/>
                     <content styleCode="bold">Cartridge Belt</content>
                  </paragraph>
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                     <text>Principal Display Panel – Cartridge Label </text>
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