<content styleCode="bold">ECOMECTIN</content> <br/> <content styleCode="bold">Cattle Pour-On</content> <br/> <content styleCode="bold">(ivermectin topical solution)</content>


               
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               <text>
                  <paragraph>
                     <content styleCode="bold">ECOMECTIN</content>
                     <br/>
                     <content styleCode="bold">CATTLE POUR-ON</content>
                     <br/>
                     <content styleCode="bold">(ivermectin topical solution)</content>
                     <br/>
                     <content styleCode="bold">Parasiticide for cattle</content>
                     <br/>
                     <content styleCode="bold">Contains 5 mg/mL ivermectin</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.</content>
                  </paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">INTRODUCTION</content>
                     <br/>Ecomectin Cattle Pour-On (ivermectin topical solution) delivers internal and external parasite control in one convenient low-volume application. Ecomectin Cattle Pour-On (ivermectin topical solution) contains ivermectin, a unique chemical entity.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">MODE OF ACTION</content>
                     <br/>Ivermectin is a member of the macrocylic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS</content>
                     <br/>Ecomectin Cattle Pour-On (ivermectin topical solution) applied<br/>at the recommended dose level of 500 mcg/kg is indicated for the effective control of these parasites.</paragraph>
                  <table border="1" cellspacing="0" cellpadding="0">
                     <tbody>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Gastrointestinal Roundworms</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Ostertagia ostertagi</content> (including inhibited stage)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Haemonchus placei</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Trichostrongylus axei</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">T. colubriformis</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Cooperia oncophora</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Cooperia punctata</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Cooperia surnabada</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Strongyloides papillosu</content>s</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Oesophagostomum radiatum</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Trichuris</content> spp.</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Lungworms</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Dictyocaulus viviparus</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(adults and L4)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Cattle Grubs</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>(parasitic stages)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Hypoderma bovis</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  H. lineatum</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Mites</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Sarcoptes scabiei</content> var. <content styleCode="italics">bovis</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Lice</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Linognathus vituli</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Haematopinus eurysternus</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Damalinia bovis</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Solenopotes capillatus</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Horn Flies</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">  Haematobia irritans</content>
                              </paragraph>
                           </td>
                           <td/>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">PERSISTENT ACTIVITY</content>
                     <br/>Ecomectin Cattle Pour-On (ivermectin topical solution) has been proved to effectively control infections and to protect cattle from re-infection with: <content styleCode="italics">Oesophagostomum radiatum</content> and <content styleCode="italics">Dictyocaulus viviparus</content> for 28 days after treatment; <content styleCode="italics">Cooperia punctata</content> and <content styleCode="italics">Trichostrongylus axei</content> for 21 days after treatment; <content styleCode="italics">Ostertagia ostertagi</content>, <content styleCode="italics">Haemonchus placei</content>, <content styleCode="italics">Cooperia oncophora</content> and <content styleCode="italics">Cooperia surnabada</content> for 14 days after treatment; <content styleCode="italics">Damalinia bovis</content> for 56 days after treatment.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">TREATMENT OF CATTLE FOR HORN FLIES</content>
                     <br/>Ecomectin Cattle Pour-On (ivermectin topical solution) controls horn flies (<content styleCode="italics">Haematobia irritans</content>) for up to 28 days after dosing. For best results Ecomectin Cattle Pour-On (ivermectin topical solution) should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE</content>
                     <br/>The dose rate is 1 mL for each 22 lb of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tailhead.<br/>Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
                  <paragraph>
                     <content styleCode="bold">ADMINISTRATION</content>
                     <br/>Collapsible packs (1L, 4L, 10L and 20L)</paragraph>
                  <paragraph>Connect the applicator gun to the collapsible pack as follows:</paragraph>
                  <paragraph>1. Attach the open end of the draw-off tubing to the dosing gun and attach draw-off tubing to the self-venting cap with the stem. (Because of the solvents used in Ecomectin Pour-On for Cattle (ivermectin topical solution), use dosing equipment compatible with Ecomectin Pour-On for Cattle. Follow manufacturers directions for use and care of the equipment. Other dosing equipment may be incompatible resulting in locking, incorrect dosage and leakage.<br/>2. Replace the shipping cap with the self-venting draw-off cap which has the stem and tighten this cap.<br/>3. Invert the pack and gently prime the dosing gun, check for leaks.<br/>4. Follow the manufacturer’s directions for adjusting the dose.<br/>5. When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container.<br/>6. Follow the applicator gun manufacturer’s directions for priming the gun, adjusting the dose, and care of the applicator gun following use.</paragraph>
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                     <tbody>
                        <tr>
                           <td valign="top">
                              <paragraph>Weight</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      Dose</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>220 lb (100 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      10 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>330 lb (150 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      15 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>440 lb (200 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      20 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>550 lb (250 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      25 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>660 lb (300 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      30 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>770 lb (350 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      35 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>880 lb (400 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      40 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>990 lb (450 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      45 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>1100 lb (500 kg)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      50 mL</paragraph>
                           </td>
                        </tr>
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                  <paragraph/>
                  <paragraph/>
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                  <paragraph>
                     <content styleCode="bold">ANIMAL SAFETY</content>
                     <br/>Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically<br/>applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which<br/>had no effect on breeding performance.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">WARNING</content>
                     <br/>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                     <br/>
                     <content styleCode="bold">Keep this and all drugs out of the reach of children.</content>
                     <br/>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS),<br/>contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse<br/>drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNING! FLAMMABLE!<br/>KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME,<br/>AND OTHER SOURCES OF IGNITION.</content>
                  </paragraph>
                  <paragraph>This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through<br/>the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin<br/>contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with<br/>water and seek medical attention.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNING:</content> Cattle must not be treated within 48 days of slaughter for human consumption. Because a<br/>withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period<br/>has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS</content>
                     <br/>
                     <content styleCode="bold">• Store at or below 25°C (77°F) and protect from light.</content>
                     <br/>
                     <content styleCode="bold">Excursions permitted to 104°F (40°C).</content>
                     <br/>• Use only in well-ventilated areas or outdoors.<br/>• Close container tightly when not in use.<br/>• Cattle should not be treated when hair or hide is wet since<br/>reduced efficacy may be experienced.<br/>• Do not use when rain is expected to wet cattle within six hours<br/>after treatment.<br/>• This product is for application to skin surface only. Do not give<br/>orally or parenterally.<br/>• Cloudiness in the formulation may occur when Ecomectin Cattle<br/>Pour-On (ivermectin topical solution) is stored at temperatures<br/>below 32°F. Allowing to warm at room temperature will restore<br/>the normal appearance without affecting efficacy.<br/>• Antiparasitic activity of ivermectin will be impaired if the<br/>formulation is applied to areas of the skin with mange scabs or<br/>lesions, or with dermatoses or adherent materials, e.g., caked<br/>mud or manure.<br/>• Ivermectin has been associated with adverse reactions in<br/>sensitive dogs; therefore, Ecomectin Cattle Pour-On (ivermectin<br/>topical solution) is not recommended for use in species other<br/>than cattle.<br/>• Restricted Drug (California) - Use only as directed.</paragraph>
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                     <content styleCode="bold">WHEN TO TREAT CATTLE WITH GRUBS</content>
                     <br/>Ecomectin Cattle Pour-On (ivermectin topical solution) effectively controls all stages of cattle grubs. However, proper timing of<br/>treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble<br/>fly) season. While this is not peculiar to ivermectin, destruction of <content styleCode="italics">Hypoderma larvae</content> (cattle grubs) at the period when these grubs<br/>are in vital areas may cause undesirable host-parasite reactions. Killing <content styleCode="italics">Hypoderma lineatum</content> when it is in the esophageal tissues<br/>may cause bloat; killing <content styleCode="italics">H. bovis</content> when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either<br/>before or after these stages of grub development. <br/>Cattle treated with Ecomectin Cattle Pour-On (ivermectin topical solution) at the end of the fly season may be re-treated with<br/>Ecomectin Cattle Pour-On (ivermectin topical solution) during the winter without danger of grub-related reactions. For further<br/>information and advice on a planned parasite control program, consult your veterinarian.</paragraph>
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                     <br/>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.</paragraph>
                  <paragraph>Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the<br/>animal(s) to be treated may slow the development of parasite resistance.</paragraph>
                  <paragraph>Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is<br/>appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment<br/>should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).</paragraph>
                  <paragraph>A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of<br/>resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
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                     <br/>Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive<br/>over time. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams<br/>or ponds for at least six hours after treatment. Do not contaminate water by direct application or by the improper<br/>disposal of drug containers. Dispose of containers in an approved landfill or by incineration.</paragraph>
                  <paragraph>As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of<br/>pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such<br/>effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an<br/>adverse impact on populations of dung-dependent insects.</paragraph>
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                     <br/>Ecomectin Cattle Pour-On is supplied in 1L, 4L, 10L, and 20L<br/>collapsible pack, including a self-venting draw-off assembly<br/>designed for use with automatic dosing equipment. Each 1L<br/>solution pack contains enough solution to treat 40 x 250 kg of body<br/>weight. Each 4L solution pack contains enough solution to treat<br/>160 x 250 kg of body weight. Each 10L solution pack contains<br/>enough solution to treat 400 x 250 kg of body weight. Each 20L<br/>solution pack contains enough solution to treat 800 x 250 kg of<br/>body weight.</paragraph>
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                     <content styleCode="bold">Approved by FDA under ANADA # 200-348</content>
                     <br/>Manufactured for<br/>Huvepharma, Inc.<br/>Peachtree City, Georgia 30269<br/>Made in Canada</paragraph>
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