Label: IVERMECTIN CATTLE POUR-ON- ivermectin solution

Ivermectin
CATTLE POUR-ON
(ivermectin topical solution)
Parasiticide for cattle
Contains 5 mg/mL ivermectin

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

INTRODUCTION
Ivermectin Pour-On™ (ivermectin topical solution) delivers internal and external parasite control in one convenient low-volume application.
Ivermectin Pour-On 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 (ivermectin topical solution) applied at the recommended dose level of 500 mcg/kg is indicated for the effective control of these parasites.

PERSISTENT ACTIVITY
Ivermectin Pour-On (ivermectin topical solution) has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparus 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 controls (ivermectin topical solution)controls horn flies (Haematobia irritans) 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.

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.
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.

ADMINISTRATION
Collapsible packs (1L, 4L, 10L and 20L)

Connect the applicator gun to the collapsible pack as follows:
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 Ivermectin Pour-On (ivermectin topical solution), use dosing equipment compatible with Ivermectin
       Pour-On. Follow manufacturers directions for use and care of the equipment. Other dosing equipment may be incompatible resulting
       in locking, incorrect dosage and leakage.
2.    Replace the shipping cap with the self-venting draw-off cap which has the stem and tighten this cap.
3.    Invert the pack and gently prime the dosing gun, check for leaks.
4.    Follow the manufacturer’s directions for adjusting the dose.
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.
6.    Follow the applicator gun manufacturer’s directions for priming the gun, adjusting the dose, and care of the applicator gun following use.

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 the reach of children.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS),
contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse
drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

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: Cattle must not be treated within 48 days of slaughter for human consumption. Because a
withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period
has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

PRECAUTIONS
•    Store at or below 25°C (77°F) and protect from light.
      Excursions permitted to 104°F (40°C).
•    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 Cattle
      Pour-On (ivermectin topical solution) 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 dermatoses or adherent materials, e.g., caked
      mud or manure.
•    Ivermectin has been associated with adverse reactions in
      sensitive dogs; therefore, Ivermectin Cattle Pour-On (ivermectin
      topical solution) 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 (ivermectin topical solution) 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 (ivermectin topical solution) at the end of the fly season may be re-treated with
Ivermectin Pour-On (ivermectin topical solution) during the winter without danger of grub-related reactions. For further
information and advice on a planned parasite control program, consult your veterinarian.

OTHER WARNINGS
Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.

Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the
animal(s) to be treated may slow the development of parasite resistance.

Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is
appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment
should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).

A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of
resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

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 is supplied in 1L, 4L, 10L, and 20L
collapsible pack, including a self-venting draw-off assembly
designed for use with automatic dosing equipment. Each 1L
solution pack contains enough solution to treat 40 x 250 kg of body
weight. Each 4L solution pack contains enough solution to treat
160 x 250 kg of body weight. Each 10L solution pack contains
enough solution to treat 400 x 250 kg of body weight. Each 20L
solution pack contains enough solution to treat 800 x 250 kg of
body weight.

Approved by FDA under ANADA # 200-348
Manufactured for
Durvet, Inc.
Blue Springs, MO 64014
Made in Canada