<text/> <effectiveTime value="20251120"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="30798-971" codeSystem="2.16.840.1.113883.6.69"/> <name>Ivermectin Cattle Pour-On</name> <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SOLUTION"/> <asEntityWithGeneric> <genericMedicine> <name>ivermectin</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="5" unit="mg"/> <denominator value="1" unit="mL"/> </quantity> <ingredientSubstance> <code code="8883YP2R6D" codeSystem="2.16.840.1.113883.4.9"/> <name>ivermectin</name> <activeMoiety> <activeMoiety> <code code="8883YP2R6D" codeSystem="2.16.840.1.113883.4.9"/> <name>IVERMECTIN</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="9M64UO4C25" codeSystem="2.16.840.1.113883.4.9"/> <name>CETEARYL ETHYLHEXANOATE</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="4000" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="30798-971-73" 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="20251120"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="ANADA200348" root="2.16.840.1.113883.3.150"/> <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/> <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="L614cfe63-752b-4d91-811b-bb064bf41d42"> <id root="beaca7b4-2a74-4f7e-8ddd-4676daba1791"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">Ivermectin</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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="La41bfa59-7eee-4180-846e-2a34f509e764"> <id root="b5dee8f7-f66f-49a2-b675-f0980fbcf55a"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">INTRODUCTION</content> <br/>Ivermectin Pour-On™ (ivermectin topical solution) delivers internal and external parasite control in one convenient low-volume application.<br/>Ivermectin Pour-On contains ivermectin, a unique chemical entity.</paragraph> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L77f4a37a-0e40-434b-8eda-f1138cf1f77c"> <id root="262aa0d1-93c0-499e-ba9b-fb452de7521d"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <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<br/>bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells.</paragraph> <paragraph>This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle<br/>cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride<br/>channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).</paragraph> <paragraph>The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride<br/>channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily<br/>cross the blood-brain barrier.</paragraph> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L5326e7b8-1b80-47e0-a0c7-d42200fd00dd"> <id root="6d313bdc-b5ca-4920-9351-65a752eb4eb5"/> <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/> <text> <paragraph> <content styleCode="bold">INDICATIONS</content> <br/>Ivermectin Pour-On (ivermectin topical solution) applied 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> </paragraph> <paragraph>(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 eurystemus</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/> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L09c80716-1725-42e8-bdf6-069d354f8aca"> <id root="1926c45b-d8a8-42ed-9df0-ea3320b6032f"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">PERSISTENT ACTIVITY</content> <br/>Ivermectin Pour-On (ivermectin topical solution) has been proved to effectively control infections and to protect cattle from re-infection with: <content styleCode="italics">Oesophagostomum </content> <content styleCode="italics">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> <paragraph/> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L5618a222-498e-4a2f-bea8-d69a09e63eb2"> <id root="9275e5b1-86f7-45db-b35b-30df4296c87a"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">TREATMENT OF CATTLE FOR HORN FLIES</content> <br/>Ivermectin Pour-On controls (ivermectin topical solution)controls horn flies (<content styleCode="italics">Haematobia irritans</content>) for up to 28 days after dosing. For best results Ivermectin 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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L678b8bd3-e80a-42aa-aa5c-555fddbfb513"> <id root="88107caa-64b4-43a8-baca-eb287a6c18fa"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <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<br/>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,<br/>and encourage the development of parasite resistance.</paragraph> <paragraph> <content styleCode="bold">ADMINISTRATION</content> <br/> <content styleCode="italics">Collapsible packs (1L, 4L, 10L and 20L)</content> </paragraph> <paragraph>Connect the applicator gun to the collapsible pack as follows:<br/>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.<br/>       (Because of the solvents used in Ivermectin Pour-On (ivermectin topical solution), use dosing equipment compatible with Ivermectin<br/>       Pour-On. Follow manufacturers directions for use and care of the equipment. Other dosing equipment may be incompatible resulting<br/>       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<br/>       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> <table border="1" cellspacing="0" cellpadding="0"> <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> </tbody> </table> <paragraph/> <paragraph/> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L18513e9a-7ec8-4758-8ea7-e44a20f0ea63"> <id root="c6c15e87-6230-4707-acca-3163b88db6d9"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L173e8047-ed87-40cc-8105-dff30c2e06b4"> <id root="f3a6929f-aea6-4744-b3b2-67c915b1ea8f"/> <code code="50741-8" codeSystem="2.16.840.1.113883.6.1" displayName="SAFE HANDLING WARNING SECTION"/> <text> <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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L6eec422a-85dc-44b0-806c-cf26525d1de1"> <id root="bfea9475-a99e-40d5-b1d9-fe5702baabc9"/> <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/> <text> <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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L7132b16f-7f26-4f9b-bd15-99fa0d0cbdd7"> <id root="3c7e1302-b7aa-40e6-a582-bde4e93ede89"/> <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/> <text> <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 Ivermectin 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, Ivermectin 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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L05a38d36-9fb9-4834-904d-52454f6c4a80"> <id root="012839ea-8c45-463f-b3ce-53e1606d831d"/> <code code="50744-2" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR OWNERS/CAREGIVERS SECTION"/> <text> <paragraph> <content styleCode="bold">WHEN TO TREAT CATTLE WITH GRUBS</content> <br/>Ivermectin 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. </paragraph> <paragraph>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. </paragraph> <paragraph>Cattle treated with Ivermectin Pour-On (ivermectin topical solution) at the end of the fly season may be re-treated with<br/>Ivermectin 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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L4ac7e6c5-5bfe-4248-a122-5cfb30720f97"> <id root="f71d9816-ab8a-4ec5-b96e-02a4d79d1b6a"/> <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/> <text> <paragraph> <content styleCode="bold">OTHER WARNINGS</content> <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> </text> <effectiveTime value="20251104"/> </section> </component> <component> <section ID="La267b783-1709-4936-961c-eafea2d4342d"> <id root="33d4296d-26fc-4241-a3cd-a05ad4225484"/> <code code="50742-6" codeSystem="2.16.840.1.113883.6.1" displayName="ENVIRONMENTAL WARNING SECTION"/> <text> <paragraph> <content styleCode="bold">ENVIRONMENTAL SAFETY</content> <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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L07799ba9-7851-49ba-b642-d3be89d7ced2"> <id root="81a4a419-15c8-4cb6-8629-25057080f902"/> <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/> <text> <paragraph> <content styleCode="bold">HOW SUPPLIED</content> <br/>Ivermectin 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> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L68e74256-740a-4c55-8a62-b29a3bfb6587"> <id root="585dbd66-12ed-49c1-b575-05455f32a40f"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">Approved by FDA under ANADA # 200-348</content> <br/>Manufactured for<br/>Durvet, Inc.<br/>Blue Springs, MO 64014<br/>Made in Canada</paragraph> </text> <effectiveTime value="20260409"/> </section> </component> <component> <section ID="L767cfe02-1c55-413e-babd-5abb96c7c8e2"> <id root="c0725475-05db-42bf-b7f7-e4d8d26e8ae4"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <paragraph> <renderMultiMedia referencedObject="L2675aa3f-b398-4d68-9dd2-af3c4c135c46"/> <renderMultiMedia referencedObject="L4f2c8ddd-1cac-4ad6-baf1-1dc74d45ec00"/> </paragraph> <paragraph> <renderMultiMedia referencedObject="Lf63b1e4c-908a-4740-b760-750d4916a21b"/> </paragraph> <paragraph> <renderMultiMedia referencedObject="Lab50c103-c4b0-4d76-a790-4af76d748cb2"/> </paragraph> </text> <effectiveTime value="20260409"/> <component> <observationMedia ID="L2675aa3f-b398-4d68-9dd2-af3c4c135c46"> <text>Insert P1</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="ivermectinpo4LINSERTsolvetfinal091125__Page_1.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="L4f2c8ddd-1cac-4ad6-baf1-1dc74d45ec00"> <text>Insert P2</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="ivermectinpo4LINSERTsolvetfinal091125_Page_2.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="Lf63b1e4c-908a-4740-b760-750d4916a21b"> <text>4L Bottle P1</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Ivermectin Pour On Bottle Rev. 11-2025 p1.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="Lab50c103-c4b0-4d76-a790-4af76d748cb2"> <text>4L Bottle P2</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Ivermectin Pour On Bottle Rev. 11-2025 p2.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>