IVERMAX- ivermectin solution 
RXV

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Ivermax (ivermectin) Pour-On for Cattle ANADA 200-318, Approved by FDA Contains 5 mg ivermectin/mL Parasiticide Consult you veterinarian for assistance in the diagnosis, treatment and control of parasitism. Introduction: Ivermax (ivermectin)Pour-On delivers internal and external parasite control in one convenient low-volume application. Ivermax Pour-On contains ivermectin, a unique chemical entity.

Indications

INDICATIONS:  For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, horn flies, sucking and biting lice, and sarcoptic mange mites in cattle.

See package insert for the complete indications and use directions.

Dosage and Administration

Recommended Dose:  1 mL per 22 lb of body weight.

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:  Squeez-Measure-Pour System (33.8 fl oz 1 Liter Bottle with 25 mL Measuring Cap)

Attach metering cap to the bottle.

Select the correct dose rate by rotating the adjuster cap in either direction to position the dose indicator to the appropriate dose.

Gently squeeze the bottle to fill to level (any excess will return to the bottle) and then tip and apply to animal along topline.

Back Pack (84.5 fl oz2.5 Liter Pack and 169 fl oz/5 Liter Pack).

Connect the applicator  gun to the backpack as follows:  Attach the open end of the draw-off tubing  to the dosing equipment.  (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supplies Limited, or equivalent, is recommended.  Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).

Replace the shipping cap with the draw-off cap.

Gently prime the applicator gun, checking for leaks.

Follow the manufacture's directions for adjusting the dose.

When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the container and empty the product from the gun and tubing back into the product container.  To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.

Free standing bottle (338 fl oz/10 Liter Bottle and 676 fl oz/20 Liter Bottle)

Connect the applicator gun to the bottle as follows:  Attach the open end of the draw-off tubing to the dosing equipment.  (Because of the solvents used inthe formulation, only the Protector Drench Gun from Instrument Supply Limited, or equivalent is recommended.  Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).

Replace the shipping cap with the draw-off cap and tighten down.

Attach draw-off tubing to the draw-off cap.

Gently prime the applicator gun, checking for leaks.

Follow the manufacturer's directions for adjusting the dose.

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.  Replace the draw-off cap with the shipping cap.  To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.  If the shipping cap is to be used with the faucet spigot installed (which can be used for refilling the 33.8 fl oz/ 1 Liter Bottle, 84.5 fl oz/2.5 Liter Pack or 169 oz/5 Liter Pack), pop the plastic seal out of the center of the shipping cap, screw in the threaded spigot, and tighten down.  Store the bottle upright, with the spigot in the off position between uses.

Mode of Action

Mode of Action:  Ivermectin is a member of the macrocyclic 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 the glutamate-gated chloride channel, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channel and they do not readily cross the blood-brain barrier.

Animal Safety

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 has no effect on breeding performance.

Warning

WARNING!  NOT FOR USE IN HUMANS.

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.

Keep this and all drugs out of the 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 Bimeda, Inc. at 1-888-524-6332.

WARNING!  FLAMMABLE!

KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.


Precautions


PRECAUTIONS

Store away from excessive heat (104 degrees F/40 degrees C) and protect from light.

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.


Package Label Display Panel

IVERMAX

(ivermectin) Pour-On for Cattle

Parasiticide


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

NET CONTENTS:  676 fl oz (20 Liter)

Contains 800-550 lb Doses

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

WARNING!  NOT FOR USE IN HUMANS.

ANADA 200-318, Approved by FDA


image of 5 liter bottle


image of back 5 liter carton


image of 20 liter bottle front


image of 20 liter bottle back


IVERMAX 
ivermectin solution
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:14049-912
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ivermectin (Ivermectin) Ivermectin5 mg  in 20 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14049-912-0120 L in 1 BOTTLE
2NDC:14049-912-025 L in 1 BOTTLE
3NDC:14049-912-035 L in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20031810/01/200904/28/2014
Labeler - RXV (059580480)

Revised: 4/2014
 
RXV