Label: IVERMECTIN POUR-ON FOR CATTLE- ivermectin solution

  • NDC Code(s): 30798-927-13, 30798-927-19, 30798-927-20, 30798-927-78
  • Packager: Durvet
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated August 14, 2019

If you are a consumer or patient please visit this version.

  • OTHER SAFETY INFORMATION

    PARASITICIDE Kills: Roundworms (including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Flies

    image of base black box warning

    WARNING! FLAMMABLE! KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.
    ANADA 200-340, Approved by FDA
    Restricted Drug (California) - Use Only as Directed

  • KEEP OUT OF REACH OF CHILDREN

    For Animal Use Only • Keep Out of Reach of Children

  • INFORMATION FOR OWNERS/CAREGIVERS

    www.durvet.com

    See attached booklet for complete indications and use directions.

  • Parasiticide

    Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

  • INTRODUCTION

    Ivermectin Pour-On for Cattle (ivermectin topical solution) delivers internal and external parasite control in one convenient low-volume application. Ivermectin Pour-On for Cattle contains ivermectin, a unique chemical entity.

  • MODE OF ACTION

    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.

  • INDICATIONS

    Ivermectin Pour-On for Cattle applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.

    Gastrointestinal Roundworms
    Ostertagia ostertagi (including inhibited stage)       (adults and L4)
    Haemonchus placei                                                (adults and L4)
    Trichostrongylus axei                                             (adults and L4)
    T. colubriformis                                                      (adults and L4)
    Cooperia oncophora                                                (adults and L4)
    Cooperia punctata                                                  (adults and L4)
    Cooperia surnabada                                                (adults and L4)
    Strongyloides papillosus                                                     (adults)
    Oesophagostomum radiatum                                  (adults and L4)
    Trichuris spp.                                                                    (adults)
    Lungworms
    Dictyocaulus viviparus                                             (adults and L4)
    Cattle Grubs                                                      (parasitic stages)
    Hypoderma bovis
    H. lineatum
    Mites
    Sarcoptes scabiei var. Bovis
    Lice
    Linognathus vituli
    Haematopinus eurystemus
    Damalinia bovis
    Solenopotes capillatus
    Horn Flies
    Haematobia irritans
    PERSISTENT ACTIVITY
    Ivermectin Pour-On for Cattle has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.
    TREATMENT OF CATTLE FOR HORN FLIES
    Ivermectin Pour-On for Cattle controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Ivermectin Pour-On for Cattle 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.

  • DOSAGE

    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.
    ADMINISTRATION
    For the 250 mL and 1 Liter containers, see the diagram on the last page of this insert. Each 5 mL will treat 110 lbs body weight. When body weight requires a drug product volume that is between the measuring markings, use the next higher increment.
    Applicator Gun
    (2.5 L, 5 L and 5 gallon bottles)
    Because of the solvents used in Ivermectin Pour-On for Cattle, an applicator gun is recommended.
    Follow the applicator gun manufacturer’s directions for priming the gun, adjusting the dose, and care of the applicator gun following use.

     Weight   Dose
     220   lb (100 kg) 10 mL
     330   lb (150kg) 15 mL
     440   lb (200 kg) 20 mL
     550   lb (250 kg) 25 mL
     660   lb (300 kg) 30 mL
     770   lb (350 kg) 35 mL
     880   lb (400 kg) 40 mL
     990   lb (450 kg) 45 mL
     1100 lb (500 kg) 50 mL

  • ANIMAL SAFETY

    Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.

    WARNING! NOT FOR USE IN HUMANS

    Keep this and all drugs out of reach of children.

    The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact First Priority, Inc. at 1-800-650-4899.

    WARNING! FLAMMABLE! KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION

    This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.

  • RESIDUE WARNING

    image of residue statement

  • PRECAUTIONS:

    Store at or below 25ºC (77ºF) and protect from light. Excursions permitted to 104ºF (40ºC).
    • Use only in well-ventilated areas or outdoors.
    • Close container tightly when not in use.
    • Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.
    • Do not use when rain is expected to wet cattle within six hours after treatment.
    • This product is for application to skin surface only. Do not give orally or parenterally.
    • Cloudiness in the formulation may occur when Ivermectin Pour-On for Cattle is stored at temperatures below 32°F. Allowing to warm at    room    temperature will restore the normal appearance without affecting efficacy.
    • Antiparasitic activity of ivermectin will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with    dermatosis or adherent materials, e.g., caked mud or manure.
    • Ivermectin has been associated with adverse reactions in sensitive dogs; therefore, Ivermectin Pour-On for Cattle is not recommended for    use in species other than cattle.
    • Restricted Drug (California) - Use only as directed.

  • When to Treat Cattle with Grubs

    Ivermectin Pour-On for Cattle effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.
    Cattle treated with Ivermectin Pour-On for Cattle at the end of the fly season may be re-treated with Ivermectin Pour-On for Cattle during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

  • Environmental Safety

    Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least six hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.
    As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

  • HOW SUPPLIED:

    Ivermectin Pour-On for Cattle is available in 250 mL (8.5 fl oz) and 1 L (33.8 fl oz) tip and measure bottles, and 2.5 L (84.5 fl oz), 5 L (169.0 fl oz), and 5 Gallon (639.0 fl oz) containers for use with an appropriate automatic dosing applicator.

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured for:
    Durvet Inc.
    Blue Springs, Missouri 64014
    www.durvet.com

    image of logo flag eye clock

  • DIAGRAM OF DEVICE

    image of tip n measure diagram

  • 250 mL ContainerrISSU18XB02

    image of 250 mL base container labelimage of 250 mL onsert container labelimage of of 250 mL individual carton label

  • 1.0 L Container/Carton rISSU18XB02/rISS16XB04

    image of 1.0 L base labelimage of 1.0 L base label onsert pg 1image  of 1.0 L base label onsert pg 2image of 1.0 L base individual carton label

  • 2.5 L Container/Cartonrev. ISS18XB02

    image of 2.5 L container labelimage of 2.5 L onsert page 1image of 2.5 L onsert page 2image of 2.5 L carton/case label

  • 5.0 L Container/Cartonrev. ISSU18XB02

    image of 5 L container labelimage of 5 L container onsert page 1image of 5 L container onsert page 2image of 5 L case label

  • INGREDIENTS AND APPEARANCE
    IVERMECTIN  POUR-ON FOR CATTLE
    ivermectin solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:30798-927
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30798-927-1312 in 1 CASE
    1250 mL in 1 BOTTLE, PLASTIC
    2NDC:30798-927-2012 in 1 CASE
    21000 mL in 1 BOTTLE, PLASTIC
    3NDC:30798-927-784 in 1 CASE
    32500 mL in 1 BOTTLE, PLASTIC
    4NDC:30798-927-192 in 1 CASE
    45000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20034009/15/2014
    Labeler - Durvet (056387798)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture, label