Eprinomectin) 99.9% Effective Against the Major Species and Stages of Parasites

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(eprinomectin) 99.9% Effective against the major species and stages of parasites

ZERO days meat withdrawal

SAME active ingredient and dosing regimen as Eprinex® (eprinomectin) ZERO milk discard

PROTECT HERD PERFORMANCE FROM 39 PARASITE SPECIES

IMPORTANT SAFETY INFORMATION: No meat or milk withdrawal is required when used according to label. Do not use in calves intended for veal or unapproved animal species as severe adverse reactions, including fatalities in dogs, may result.

Untitled-2 1 06/05/2016 16:37 Lorem ipsum

(eprinomectin)

Eprizero® Pour-On for treatment and control of 39 species and stages of parasites.

Eprizero® (eprinomectin) Pour-On contains the same active ingredient as Eprinex® (eprinomectin) Pour-On, utilizing identical dosing regimens. Eprizero® Pour-On provides excellent broad-spectrum treatment and control against internal and external parasites, and return on investment, in a convenient pour-on formulation.

DRIVE RETURN BROAD-SPECTRUM SHORTER CALVING ON INVESTMENT TREATMENT INTERVAL

Research confirms 99.9% effective Following treatment for treatment for parasites with against the major parasites with eprinomectin, eprinomectin can increase species and stages both heifers and dairy cows milk yield by 2.07 lbs show improved fertility, i.e. per cow per day.1 of parasites 58% v 38% conception rate at first service.2

ZERO ZERO MILK MEAT

DISCARD WEATHERPROOF

WITHDRAWL FORMULATION

STOPS PARASITES AT THEIR SOURCE FOR LONGER CONTROL AND SAFETY

Eggs excreted by cattle Studies have shown eprinomectin kept Adult worms eff icacy levels higher than 90% from 2 up produce eggs to 28 days3 versus competitive pour-on parasite treatments.

® ParasiteParasite Put Eprizero Pour-On to Worm larvae Work Today Life on grass Additionally, research shows that the Burrows Cycle into internal active ingredient in Eprizero® Pour-On tissue/glands causing outperformed Cydectin® (moxidectin), damage Ivomec® (ivermectin) and Dectomax® (doramectin) in head-to-head university Grazed by cattle studies.3

INTERNAL PARASITES EXTERNAL PARASITES Rain is not an issue A=ADULT STAGE L4=LARVAL STAGE Where rain is an issue after treatment, the active ingredient in Eprizero® Pour-On Brown stomach worm A, L4 Ostertagia ostertagi LICE was 99% effective against adults and immature larvae (L4) of the most Brown stomach worm L4 Biting louse (inhibited) Damalinia bovis economically significant internal parasites (worms) and nematodes Barbers pole worm A, L4 Short-nosed cattle louse 4 Haemonchus placei Haematopinus eurysternus found in cattle.

Black scour worm A, L4 Long-nosed cattle louse Trichostrongylus colubriformis Linognathus vituli

Thread-necked intestinal worm A, L4 Small blue louse Nematodirus helvetianus Solenopotes capillatus ® Eprizero Pour-On Intestinal threadworm A Strongyloides papillosus GRUBS - A Higher Level of Convenience and Safety Nodular worm A, L4 Northern cattle grub 1/2/3 instar Oesophagostomum radiatum Hypoderma bovis • Kills 39 species and stages of internal/ Whipworm A Common cattle grub 1/2/3 instar external parasites Trichuris spp Hypoderma lineatum Lungworm • Weatherproof formulation that works in A, L4 HORN FLIES Dictyocaulus viviparus rain, cold or heat

Small intestinal worm A, L4 Horn flies Cooperia oncophora Haematobia irritans • Zero milk discard

Small intestinal worm A, L4 • Zero days meat withdrawl C. punctata MANGE • Safe for any age animal including Small intestinal worm A, L4 Mange mite C. surnabada Sarcoptes scabiei pregnant cows, calves and bulls

Hairworm A, L4 Mange mite Nonflammable for improved safety and T. axei Chorioptes bovis (tailhead mange) • storage Black scour worm A T. longispicularis

Hookworm A, L4 Bunostomum phlebotomum Norbrook offers Eprizero® Pour-On in convenient 1 Liter, 2.5 Liter, 5 Liter and 20 Liter sizes for economical per-dose application.

Convenient Packaging to Fit YOUR Needs

Know Your Enemy External parasites such as lice, flies, ticks, grubs and mites limit dairy production and animal welfare. External parasites: • Feed on body tissues such as blood, skin and hair • Produce wounds and skin irritation • Transmit diseases from infected animals to healthy ones • Cause depressed appetite and subsequent weight loss, reduced milk production and general weakness • Create sites for secondary invasion of disease organisms

Internal parasites are the most economically damaging parasites and are particularly detrimental in mature dairy cows at calving and during lactation resulting in serious economic losses. Internal parasites: • Loss of milk yield • Reduced feed intake and dramatically lowered live weight gain • Reduced body condition DOSING GUIDE

Body Dose Number of doses per pack Weight Volume 1 L 2.5 L 5 L 20 L 220 lbs (100 kg) 10 mL 100 250 500 2000 330 lbs (150 kg) 15 mL 66 166 333 1333 440 lbs (200 kg) 20 mL 50 125 250 1000 550 lbs (250 kg) 25 mL 40 100 200 800 660 lbs (300 kg) 30 mL 33 83 166 666 880 lbs (400 kg) 40 mL 25 62 125 500 990 lbs (450 kg) 45 mL 22 55 111 444 1100 lbs (500 kg) 50 mL 20 50 100 400

TREATMENT REGIMEN Administer Eprizero® Pour-On only by topical application at the dose rate of 1 mL per 10 kg (22 lb) of body weight, corresponding to the recommended dose rate of 0.5 mg eprinomectin per kg of body weight. The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead. Rainfall at any time before or after treatment will not affect the efficacy of the product. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device (dosing cup or dosing gun delivery system) should be checked. For best results use as part of a program to control both internal and external parasites of cattle based on the epidemiology of these parasites. ANADA 200-563, Approved by FDA Lungworms Container (84.5 fl oz/2.5 liter pack; 169 fl oz/5 liter pack) PRECAUTIONS Dictyocaulus viviparus (adults and L4) The applicator gun from Simcro Tech, or equivalent, is This product is for topical application only. Do not administer orally or by injection. Cattle Grubs (all parasitic stages) recommended. Other applicators may exhibit compatibility Do not apply to areas of the backline covered with mud or manure. ® Hypoderma lineatum problems resulting in locking, incorrect dosage or leakage. Remove Eprizero Pour-On is not recommended for use in species other than cattle. Hypoderma bovis the shipping cap from the backpack container and replace with the vent cap provided. Attach the hose from the automatic dosing Severe adverse reactions have been reported in other species treated Lice equipment to the outlet from the vent cap. Follow the applicator with products containing compounds of this class. Damalinia bovis gun manufacturer’s directions for priming the gun, adjusting the Linognathus vituli dose, and care of the applicator gun following use. When to Treat Cattle with Grubs Haematopinus eurysternus Eprizero Pour-On is effective against all stages of cattle grubs. However, (eprinomectin) Solenopotes capillatus Container (676 fl oz/20 liter container with draw-off device) proper timing of treatment is important. For the most effective results, The draw-off device and applicator gun from Simcro Tech, or cattle should be treated as soon as possible after the end of the heel fly POUR-ON for Beef and Dairy Cattle Mange Mites equivalent, is recommended. Other applicators may exhibit (warble fly) season. While this is not peculiar to eprinomectin, destruction Chorioptes bovis compatibility problems resulting in locking, incorrect dosage or of Hypoderma larvae (cattle grubs) at the period when these grubs are in Sarcoptes scabiei leakage. Screw Feedlot pack cap and dip tube onto the 20 liter vital areas may cause undesirable host-parasite reactions. Killing Parasiticide Horn Flies drum ensuring a tight fit. Connect the long 3m feed tube at one end 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 Haematobia irritans to the spigot on the Feedlot pack cap and the other end to the Contains 5 mg eprinomectin/mL applicator gun. Then follow the applicator gun manufacturer’s paralysis. Cattle should be treated either before or after these stages of grub development. Cattle treated with Eprizero Pour-On at the end of the Not for use in calves to be processed for veal. Persistent Activity directions for priming the gun, adjusting the dose, and care of the fly season may be re-treated with Eprizero Pour-On during the winter Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle has applicator gun following use. without danger of grub-related reactions. For further information and INTRODUCTION been proved to effectively control infections and to protect cattle advice on a planned parasite control program, consult your veterinarian. Eprizero® Pour-On delivers effective internal and external parasite control from re-infection with Dictyocaulus viviparus for 21 days after When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw off tubing and dip tube in one application. Eprizero Pour-On contains eprinomectin, a unique treatment and Haematobia irritans for 7 days after treatment. ENVIRONMENTAL SAFETY avermectin. Its broad-spectrum efficacy in a weatherproof formulation, and cap from the product container, empty the product from the gun and tubing back into the container and replace the shipping cap. Studies indicate that when eprinomectin comes in contact with soil, it margin of safety, zero slaughter withdrawal and zero milk discard, make it Use Conditions readily and tightly binds to the soil and becomes inactive over time. Free a convenient product for parasite control in beef and dairy cattle, Varying weather conditions, including rainfall, do not affect the Weight Dose ivermectin/eprinomectin may adversely affect fish and certain aquatic including lactating dairy cattle. efficacy of Eprizero Pour-On. 220 lb (100 kg) 10 mL organisms. Do not permit cattle to enter lakes, streams or ponds for at least 6 hours after treatment. Do not contaminate water by direct MODE OF ACTION 330 lb (150 kg) 15 mL Management Considerations for Treatment of External Parasites application or by the improper disposal of drug containers. Dispose of Eprinomectin is a member of the macrocyclic lactone class of For best results Eprizero Pour-On should be applied to all cattle in the 440 lb (200 kg) 20 mL containers in an approved landfill or by incineration. As with other endectocides which have a unique mode of action. Compounds of the herd. Cattle introduced to the herd later should be treated prior to avermectins, eprinomectin is excreted in the dung of treated animals and class bind selectively and with high affinity to glutamate-gated chloride 550 lb (250 kg) 25 mL introduction. Consult your veterinarian or an entomologist for the most can inhibit the reproduction and growth of pest and beneficial insects that ion channels which occur in invertebrate nerve and muscle cells. This 660 lb (300 kg) 30 mL effective timing of applications for the control of external parasites. use dung as a source of food and for reproduction. The magnitude and leads to an increase in the permeability of the cell membrane to chloride 770 lb (350 kg) 35 mL duration of such effects are species and life-cycle specific. When used ions with hyperpolarization of the nerve or muscle cell, resulting in Chorioptic Mange: In clinical studies evaluating the efficacy of 880 lb (400 kg) 40 mL according to label directions, the product is not expected to have an paralysis and death of the parasite. Compounds of this class may also Eprizero Pour-On against chorioptic mange mites, mites were not 990 lb (450 kg) 45 mL adverse impact on populations of dung-dependent insects. interact with other ligand-gated chloride channels, such as those gated by recovered from skin scrapings taken 8 weeks after treatment; the neurotransmitter gamma-aminobutyric acid (GABA). The margin of 1100 lb (500 kg) 50 mL however, chronic skin lesions were still present on some animals. ADVERSE REACTIONS safety for compounds of this class is attributable to the fact that mammals ANIMAL SAFETY No adverse reactions were observed during clinical trials. do not have glutamate-gated chloride channels, the macrocyclic lactones Horn flies: For optimal control of horn flies, as Eprizero Pour-On Tolerance and toxicity studies have demonstrated the margin of safety for have a low affinity for other mammalian ligand-gated chloride channels provides 7 days of persistent activity against horn flies, the product eprinomectin in cattle. In toxicity studies, application of 3 times the STORAGE CONDITIONS and they do not readily cross the blood-brain barrier. should be used as part of an integrated control program utilizing other recommended dose had no adverse effects on neonatal calves, and Store container in the carton to protect from light and at temperatures up control methods to provide extended control. to 86° F/30° C. Storage at temperatures up to 104°F/40°C is permitted for a INDICATIONS application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance short period of time, however, such exposure should be minimized. Eprizero (eprinomectin) Pour-On is indicated for the treatment and control DOSAGE of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), study, one of 6 cattle treated once at 10 times the recommended dose The product is formulated only for external application to beef and HOW SUPPLIED lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange showed clinical signs of mydriasis. Application of 3 times the dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in mites, and horn flies in beef and dairy cattle of all ages, including lactating recommended dose had no adverse effect on breeding performance of The product should be applied topically along the backline in a 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in a dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) cows or bulls. narrow strip extending from the withers to the tailhead. 2.5 L/84.5 fl oz or 5 L/169 fl oz container or 20 L/676 fl oz container intended body weight, to achieve a dose level of 500 mcg eprinomectin/kg body for use with appropriate automatic dosing equipment. weight, Eprizero Pour-On is indicated for the effective treatment and RESIDUE WARNINGS ADMINISTRATION control of the following parasites. When used according to label directions, neither a Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with pre-slaughter drug withdrawal period nor a milk discard time Restricted Drug (California) - Use Only as Directed. dispensing cap) Gastrointestinal Roundworms is required, therefore, meat and milk from cattle treated with The dispensing cap is graduated in 5 mL increments. Each 5 mL Made in the UK. Haemonchus placei (adults and L4) Eprizero (eprinomectin) Pour-On may be used for human will treat 110 lbs body weight. When body weight is between Ostertagia ostertagi (adults and L4) consumption at any time following treatment. A withdrawal Manufactured by: (including inhibited L4) markings, use the next higher increment. Attach the dispensing period has not been established for pre-ruminating calves. Do Norbrook Laboratories Limited Trichostrongylus axei (adults and L4) cap to the container. Select the correct dose rate by rotating the not use in calves to be processed for veal. Newry, BT35 6PU, Co. Down, Northern Ireland. Trichostrongylus colubriformis (adults and L4) adjuster top in either direction to position the dose indicator to Trichostrongylus longispicularis (adults only) the appropriate level. Hold the container upright and gently WARNING ® Eprizero is a registered trademark of Norbrook Laboratories Limited. Cooperia oncophora (adults and L4) squeeze it to deliver a slight excess of the required dose as Keep this and all drugs out of the reach of children. Cooperia punctata (adults and L4) indicated by the calibration lines. By releasing the pressure, the NOT FOR USE IN HUMANS. Cooperia surnabada (adults and L4) dose automatically adjusts to the correct level. Tilt the container Nematodirus helvetianus (adults and L4) to deliver the dose. The “closed-off-shut” position will close the As with any topical medication intended for treatment of animals, skin contact Oesophagostomum radiatum (adults and L4) system between dosing. If the animal being treated weighs should be avoided. If accidental skin contact occurs, wash immediately with Bunostomum phlebotomum (adults and L4) more that 550 lbs (250 kg), refill the dispensing cap to the soap and water. If accidental eye exposure occurs, flush eyes immediately Strongyloides papillosus (adults only) additional amount required to provide the total dose for that with water. The safety data sheet (SDS) contains more detailed occupational Trichuris spp. (adults only) animal and apply as directed. safety information. To report adverse effects, obtain an SDS or for assistance, contact Norbrook at 1-866-591-5777. 121670I02

EPRIZERO POUR ON Insert Dimensions: 148 x 210 mm Text - ≥ 7.2 pt ANADA 200-563, Approved by FDA Lungworms Container (84.5 fl oz/2.5 liter pack; 169 fl oz/5 liter pack) PRECAUTIONS Dictyocaulus viviparus (adults and L4) The applicator gun from Simcro Tech, or equivalent, is This product is for topical application only. Do not administer orally or by injection. Cattle Grubs (all parasitic stages) recommended. Other applicators may exhibit compatibility Do not apply to areas of the backline covered with mud or manure. ® Hypoderma lineatum problems resulting in locking, incorrect dosage or leakage. Remove Eprizero Pour-On is not recommended for use in species other than cattle. Hypoderma bovis the shipping cap from the backpack container and replace with the vent cap provided. Attach the hose from the automatic dosing Severe adverse reactions have been reported in other species treated Lice equipment to the outlet from the vent cap. Follow the applicator with products containing compounds of this class. Damalinia bovis gun manufacturer’s directions for priming the gun, adjusting the Linognathus vituli dose, and care of the applicator gun following use. When to Treat Cattle with Grubs Haematopinus eurysternus Eprizero Pour-On is effective against all stages of cattle grubs. However, (eprinomectin) Solenopotes capillatus Container (676 fl oz/20 liter container with draw-off device) proper timing of treatment is important. For the most effective results, The draw-off device and applicator gun from Simcro Tech, or cattle should be treated as soon as possible after the end of the heel fly POUR-ON for Beef and Dairy Cattle Mange Mites equivalent, is recommended. Other applicators may exhibit (warble fly) season. While this is not peculiar to eprinomectin, destruction Chorioptes bovis compatibility problems resulting in locking, incorrect dosage or of Hypoderma larvae (cattle grubs) at the period when these grubs are in Sarcoptes scabiei leakage. Screw Feedlot pack cap and dip tube onto the 20 liter vital areas may cause undesirable host-parasite reactions. Killing Parasiticide Horn Flies drum ensuring a tight fit. Connect the long 3m feed tube at one end 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 Haematobia irritans to the spigot on the Feedlot pack cap and the other end to the Contains 5 mg eprinomectin/mL applicator gun. Then follow the applicator gun manufacturer’s paralysis. Cattle should be treated either before or after these stages of grub development. Cattle treated with Eprizero Pour-On at the end of the Not for use in calves to be processed for veal. Persistent Activity directions for priming the gun, adjusting the dose, and care of the fly season may be re-treated with Eprizero Pour-On during the winter Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle has applicator gun following use. without danger of grub-related reactions. For further information and INTRODUCTION been proved to effectively control infections and to protect cattle advice on a planned parasite control program, consult your veterinarian. Eprizero® Pour-On delivers effective internal and external parasite control from re-infection with Dictyocaulus viviparus for 21 days after When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw off tubing and dip tube in one application. Eprizero Pour-On contains eprinomectin, a unique treatment and Haematobia irritans for 7 days after treatment. ENVIRONMENTAL SAFETY avermectin. Its broad-spectrum efficacy in a weatherproof formulation, and cap from the product container, empty the product from the gun and tubing back into the container and replace the shipping cap. Studies indicate that when eprinomectin comes in contact with soil, it margin of safety, zero slaughter withdrawal and zero milk discard, make it Use Conditions readily and tightly binds to the soil and becomes inactive over time. Free a convenient product for parasite control in beef and dairy cattle, Varying weather conditions, including rainfall, do not affect the Weight Dose ivermectin/eprinomectin may adversely affect fish and certain aquatic including lactating dairy cattle. efficacy of Eprizero Pour-On. 220 lb (100 kg) 10 mL organisms. Do not permit cattle to enter lakes, streams or ponds for at least 6 hours after treatment. Do not contaminate water by direct MODE OF ACTION 330 lb (150 kg) 15 mL Management Considerations for Treatment of External Parasites application or by the improper disposal of drug containers. Dispose of Eprinomectin is a member of the macrocyclic lactone class of For best results Eprizero Pour-On should be applied to all cattle in the 440 lb (200 kg) 20 mL containers in an approved landfill or by incineration. As with other endectocides which have a unique mode of action. Compounds of the herd. Cattle introduced to the herd later should be treated prior to avermectins, eprinomectin is excreted in the dung of treated animals and class bind selectively and with high affinity to glutamate-gated chloride 550 lb (250 kg) 25 mL introduction. Consult your veterinarian or an entomologist for the most can inhibit the reproduction and growth of pest and beneficial insects that ion channels which occur in invertebrate nerve and muscle cells. This 660 lb (300 kg) 30 mL effective timing of applications for the control of external parasites. use dung as a source of food and for reproduction. The magnitude and leads to an increase in the permeability of the cell membrane to chloride 770 lb (350 kg) 35 mL duration of such effects are species and life-cycle specific. When used ions with hyperpolarization of the nerve or muscle cell, resulting in Chorioptic Mange: In clinical studies evaluating the efficacy of 880 lb (400 kg) 40 mL according to label directions, the product is not expected to have an paralysis and death of the parasite. Compounds of this class may also Eprizero Pour-On against chorioptic mange mites, mites were not 990 lb (450 kg) 45 mL adverse impact on populations of dung-dependent insects. interact with other ligand-gated chloride channels, such as those gated by recovered from skin scrapings taken 8 weeks after treatment; the neurotransmitter gamma-aminobutyric acid (GABA). The margin of 1100 lb (500 kg) 50 mL however, chronic skin lesions were still present on some animals. ADVERSE REACTIONS safety for compounds of this class is attributable to the fact that mammals ANIMAL SAFETY No adverse reactions were observed during clinical trials. do not have glutamate-gated chloride channels, the macrocyclic lactones Horn flies: For optimal control of horn flies, as Eprizero Pour-On Tolerance and toxicity studies have demonstrated the margin of safety for have a low affinity for other mammalian ligand-gated chloride channels provides 7 days of persistent activity against horn flies, the product eprinomectin in cattle. In toxicity studies, application of 3 times the STORAGE CONDITIONS and they do not readily cross the blood-brain barrier. should be used as part of an integrated control program utilizing other recommended dose had no adverse effects on neonatal calves, and Store container in the carton to protect from light and at temperatures up control methods to provide extended control. to 86° F/30° C. Storage at temperatures up to 104°F/40°C is permitted for a INDICATIONS application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance short period of time, however, such exposure should be minimized. Eprizero (eprinomectin) Pour-On is indicated for the treatment and control DOSAGE of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), study, one of 6 cattle treated once at 10 times the recommended dose The product is formulated only for external application to beef and HOW SUPPLIED lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange showed clinical signs of mydriasis. Application of 3 times the dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in mites, and horn flies in beef and dairy cattle of all ages, including lactating recommended dose had no adverse effect on breeding performance of The product should be applied topically along the backline in a 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in a dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) cows or bulls. narrow strip extending from the withers to the tailhead. 2.5 L/84.5 fl oz or 5 L/169 fl oz container or 20 L/676 fl oz container intended body weight, to achieve a dose level of 500 mcg eprinomectin/kg body for use with appropriate automatic dosing equipment. weight, Eprizero Pour-On is indicated for the effective treatment and RESIDUE WARNINGS ADMINISTRATION control of the following parasites. When used according to label directions, neither a Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with pre-slaughter drug withdrawal period nor a milk discard time Restricted Drug (California) - Use Only as Directed. dispensing cap) Gastrointestinal Roundworms is required, therefore, meat and milk from cattle treated with The dispensing cap is graduated in 5 mL increments. Each 5 mL Made in the UK. Haemonchus placei (adults and L4) Eprizero (eprinomectin) Pour-On may be used for human will treat 110 lbs body weight. When body weight is between Ostertagia ostertagi (adults and L4) consumption at any time following treatment. A withdrawal Manufactured by: (including inhibited L4) markings, use the next higher increment. Attach the dispensing period has not been established for pre-ruminating calves. Do Norbrook Laboratories Limited Trichostrongylus axei (adults and L4) cap to the container. Select the correct dose rate by rotating the not use in calves to be processed for veal. Newry, BT35 6PU, Co. Down, Northern Ireland. Trichostrongylus colubriformis (adults and L4) adjuster top in either direction to position the dose indicator to Trichostrongylus longispicularis (adults only) the appropriate level. Hold the container upright and gently WARNING ® Eprizero is a registered trademark of Norbrook Laboratories Limited. Cooperia oncophora (adults and L4) squeeze it to deliver a slight excess of the required dose as Keep this and all drugs out of the reach of children. Cooperia punctata (adults and L4) indicated by the calibration lines. By releasing the pressure, the NOT FOR USE IN HUMANS. Cooperia surnabada (adults and L4) dose automatically adjusts to the correct level. Tilt the container Nematodirus helvetianus (adults and L4) to deliver the dose. The “closed-off-shut” position will close the As with any topical medication intended for treatment of animals, skin contact Oesophagostomum radiatum (adults and L4) system between dosing. If the animal being treated weighs should be avoided. If accidental skin contact occurs, wash immediately with Bunostomum phlebotomum (adults and L4) more that 550 lbs (250 kg), refill the dispensing cap to the soap and water. If accidental eye exposure occurs, flush eyes immediately Strongyloides papillosus (adults only) additional amount required to provide the total dose for that with water. The safety data sheet (SDS) contains more detailed occupational Trichuris spp. (adults only) animal and apply as directed. safety information. To report adverse effects, obtain an SDS or for assistance, contact Norbrook at 1-866-591-5777. 121670I02

EPRIZERO POUR ON Insert Dimensions: 148 x 210 mm Text - ≥ 7.2 pt Eprizero INTRODUCTION Not for use in calves to be processed veal. Contains 5 mg eprinomectin/mL Parasiticide ANADA 200-563, Approved by FDA Gastrointestinal Roundworms control of the following parasites. weight, Eprizero Pour-On is indicated for the effective treatment and body weight, to achieve a dose level of 500 mcg eprinomectin/kg dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) mites, and horn flies in beef dairy cattle of all ages, including lactating lungworms, grubs, sucking and biting lice, chorioptic sarcoptic mange of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), Eprizero (eprinomectin) Pour-On is indicated for the treatment and control INDICATIONS and they do not readily cross the blood-brain barrier. have a low affinity for other mammalian ligand-gated chloride channels do not have glutamate-gated chloride channels, the macrocyclic lactones safety for compounds of this class is attributable to the fact that mammals the neurotransmitter gamma-aminobutyric acid (GABA). The margin of interact with other ligand-gated chloride channels, such as those gated by paralysis and death of the parasite. Compounds this class may also ions with hyperpolarization of the nerve or muscle cell, resulting in leads to an increase in the permeability of cell membrane chloride ion channels which occur in invertebrate nerve and muscle cells. This class bind selectively and with high affinity to glutamate-gated chloride endectocides which have a unique mode of action. Compounds the Eprinomectin is a member of the macrocyclic lactone class MODE OF ACTION including lactating dairy cattle . a convenient product for parasite control in beef and dairy cattle, margin of safety, zero slaughter withdrawal and milk discard, make it avermectin. Its broad-spectrum efficacy in a weatherproof formulation, in one application. Eprizero Pour-On contains eprinomectin, a unique Trichuris spp. (adults only) Strongyloides papillosus (adults only) Bunostomum phlebotomum (adults and L4) Oesophagostomum radiatum (adults and L4) Nematodirus helvetianus (adults and L4) Cooperia surnabada (adults and L4) Cooperia punctata (adults and L4) Cooperia oncophora (adults and L4) Trichostrongylus longispicularis (adults only) Trichostrongylus colubriformis (adults and L4) Trichostrongylus axei (adults and L4) (including inhibited L4) Ostertagia ostertagi Haemonchus placei (adults and L4) (eprinomectin) POUR-ON for Beef and Dairy Cattle ® Pour-On delivers effective internal and external parasite control Eprizero INTRODUCTION Not for use in calves to be processed veal. Contains 5 mg eprinomectin/mL Parasiticide ANADA 200-563, Approved by FDA Gastrointestinal Roundworms control of the following parasites. weight, Eprizero Pour-On is indicated for the effective treatment and body weight, to achieve a dose level of 500 mcg eprinomectin/kg dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) mites, and horn flies in beef dairy cattle of all ages, including lactating lungworms, grubs, sucking and biting lice, chorioptic sarcoptic mange of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), Eprizero (eprinomectin) Pour-On is indicated for the treatment and control INDICATIONS and they do not readily cross the blood-brain barrier. have a low affinity for other mammalian ligand-gated chloride channels do not have glutamate-gated chloride channels, the macrocyclic lactones safety for compounds of this class is attributable to the fact that mammals the neurotransmitter gamma-aminobutyric acid (GABA). The margin of interact with other ligand-gated chloride channels, such as those gated by paralysis and death of the parasite. Compounds this class may also ions with hyperpolarization of the nerve or muscle cell, resulting in leads to an increase in the permeability of cell membrane chloride ion channels which occur in invertebrate nerve and muscle cells. This class bind selectively and with high affinity to glutamate-gated chloride endectocides which have a unique mode of action. Compounds the Eprinomectin is a member of the macrocyclic lactone class MODE OF ACTION including lactating dairy cattle . a convenient product for parasite control in beef and dairy cattle, margin of safety, zero slaughter withdrawal and milk discard, make it avermectin. Its broad-spectrum efficacy in a weatherproof formulation, in one application. Eprizero Pour-On contains eprinomectin, a unique Trichuris spp. (adults only) Strongyloides papillosus (adults only) Bunostomum phlebotomum (adults and L4) Oesophagostomum radiatum (adults and L4) Nematodirus helvetianus (adults and L4) Cooperia surnabada (adults and L4) Cooperia punctata (adults and L4) Cooperia oncophora (adults and L4) Trichostrongylus longispicularis (adults only) Trichostrongylus colubriformis (adults and L4) Trichostrongylus axei (adults and L4) (including inhibited L4) Ostertagia ostertagi Haemonchus placei (adults and L4) (eprinomectin) POUR-ON for Beef and Dairy Cattle ® Pour-On delivers effective internal and external parasite control (adults and L4) ® to del i dose automatically adjusts to the co r indicated by the calibration lines. By releasing pressure, squee z the appropriate level. Hold container upright and gently adjuster top in either direction to position the dose indicator cap to the container. S markings, use the next higher increment. will treat 1 The dispensing cap is graduated in 5 mL increments. Ea c dispensing cap) Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with ADMINISTRATION narrow strip extending from the withers to tailhead. The product should be applied topically along the backline in a dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. The product is formulated only for external application to beef and DOSAGE control methods to provide extended control. should be used as part of an integrated control program utilizing other provides 7 days of persistent activity against horn flies, the product Horn flies: For optimal control of horn flies, as Eprizero Pour-On however, chronic skin lesions were still present on some animals. recovered from skin scrapings taken 8 weeks after treatment; Eprizero Pour-On against chorioptic mange mites, mites were not Chorioptic Mange: In clinical studies evaluating the efficacy of effective timing of applications for the control external parasites. introduction. Consult your veterinarian or an entomologist for the most herd. Cattle introduced to the herd later should be treated prior For best results Eprizero Pour-On should be applied to all cattle in the Management Considerations for Treatment of External Parasites efficacy of Eprizero Pour-On. Varying weather conditions, including rainfall, do not affect the Use Conditions treatment and Haematobia irritans for 7 days after treatment. from re-infection with Dictyocaulus viviparus for 21 days after been proved to effectively control infections and protect cattle Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle has Persistent Activity Horn Flies Mange Mites Lice Cattle Grubs (all parasitic stages) Lungworms animal and apply as directed. additional amount required to pr o more that 550 lbs (250 k system between dosing. If the animal being treated weighs Haematobia irritans Sarcoptes scabiei Chorioptes bovis Solenopotes capillatus Haematopinus eurysternus Linognathus vituli Damalinia bovis Hypoderma bovis Hypoderma lineatum Dictyocaulus viviparus (adults and L4) ver the dose. e it to del i (adults and L4) 1 0 lbs body weight. ver a slight excess of the required dose as The ® elect the co r g), refill the dispensing cap to “closed-o f to del i dose automatically adjusts to the co r indicated by the calibration lines. By releasing pressure, squee z the appropriate level. Hold container upright and gently adjuster top in either direction to position the dose indicator cap to the container. S markings, use the next higher increment. will treat 1 The dispensing cap is graduated in 5 mL increments. Ea c dispensing cap) Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with ADMINISTRATION narrow strip extending from the withers to tailhead. The product should be applied topically along the backline in a dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. The product is formulated only for external application to beef and DOSAGE control methods to provide extended control. should be used as part of an integrated control program utilizing other provides 7 days of persistent activity against horn flies, the product Horn flies: For optimal control of horn flies, as Eprizero Pour-On however, chronic skin lesions were still present on some animals. recovered from skin scrapings taken 8 weeks after treatment; Eprizero Pour-On against chorioptic mange mites, mites were not Chorioptic Mange: In clinical studies evaluating the efficacy of effective timing of applications for the control external parasites. introduction. Consult your veterinarian or an entomologist for the most herd. Cattle introduced to the herd later should be treated prior For best results Eprizero Pour-On should be applied to all cattle in the Management Considerations for Treatment of External Parasites efficacy of Eprizero Pour-On. Varying weather conditions, including rainfall, do not affect the Use Conditions treatment and Haematobia irritans for 7 days after treatment. from re-infection with Dictyocaulus viviparus for 21 days after been proved to effectively control infections and protect cattle Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle has Persistent Activity Horn Flies Mange Mites Lice Cattle Grubs (all parasitic stages) Lungworms animal and apply as directed. additional amount required to pr o more that 550 lbs (250 k system between dosing. If the animal being treated weighs Haematobia irritans Sarcoptes scabiei Chorioptes bovis Solenopotes capillatus Haematopinus eurysternus Linognathus vituli Damalinia bovis Hypoderma bovis Hypoderma lineatum Dictyocaulus viviparus (adults and L4) When body weight is between vide the total dose for that f-shut” position will close the ver the dose. e it to del i rect dose rate by rotating the rect level. 1 0 lbs body weight. A t ta c ver a slight excess of the required dose as h the dispensing T The ilt the container elect the co r g), refill the dispensing cap to “closed-o f h 5 mL When body weight is between Dimensions: 148 x 210 mm vide the total dose for that f-shut” position will close the rect dose rate by rotating the rect level. EPRIZERO POUR ON A t ta c Text - ≥ 7.2 pt h the dispensing T ilt the container Insert h 5 mL Dimensions: 148 x 210 mm EPRIZERO POUR ON contact Norbrook at 1-866-591-5777. safety information. To report adverse effects, obtain an SDS or for assistance, with water. The safety data sheet (SDS) contains more detailed occupational soap and water. If accidental eye exposure occurs, flush eyes immediately should be avoided. If accidental skin contact occurs, wash immediately with As with any topical medication intended for treatment of animals, skin contact cows or bulls. recommended dose had no adverse effect on breeding performance of showed clinical signs of mydriasis. Application 3 times the study, one of 6 cattle treated once at 10 times the recommended dose intervals had no adverse effects on 8 week old calves. In the tolerance application of up to 5 times the recommended dose 3 at 7 day recommended dose had no adverse effects on neonatal calves, and eprinomectin in cattle. In toxicity studies, application of 3 times the Tolerance and toxicity studies have demonstrated the margin of safety for ANIMAL SAFETY 330 lb ( 1 exceed When the interval between use of applicator gun is expected to Container (84.5 fl oz/2.5 liter pa c 990 lb (450 k 880 lb (4 0 770 lb (350 k 660 lb (3 0 550 lb (250 k 440 lb (2 0 and tubing ba c and cap from the product containe r compatibility problems resulting in lo c equ i gun manufacture r equipment to the outlet from vent cap. F The dra w Container (6 7 dose, and care of the applicator gun following use. vent cap pr o the shipping cap from ba c problems resulting in lo c recommended. Other applicato r The applicator gun from Simcro applicator gun following use. directions for priming the gun, adjusting dose, and care of applicator gun. to the spigot on F drum ensuring a tight fit. Connect the long 3m feed tube at one end lea k Text - ≥ 7.2 pt age. valent, is recommended. Other applicato r not use in calves to be processed for veal. period has not been established for pre-ruminating calves. Do consumption at any time following treatment. A withdrawal Eprizero (eprinomectin) Pour-On may be used for human is required, therefore, meat and milk from cattle treated with pre-slaughter drug withdrawal period nor a milk discard time When used according to label directions, neither a RESIDUE WARNINGS 1 2 hou r 1 Insert S 220 lb ( 1 -o f 1 Keep this and all drugs out of the reach children. crew 0 0 lb (5 f device and applicator gun from Simcro vided. W 6 fl oz/20 liter container with dra w k into the container and replace shipping cap. eight Dose s, disconnect the gun, draw o f Then follow the applicator gun manufacture r F eedlot pa c 0 50 ’ s directions for priming the gun, adjusting 0 0 0 0 A 0 k k k k k t k eedlot pa c ta c NOT FOR USE IN HUMANS. g) g) g) g) g) g) g) g) g) h the hose from automatic dosing king, inco r k cap and dip tube onto the 20 liter 330 lb ( 1 contact Norbrook at 1-866-591-5777. safety information. To report adverse effects, obtain an SDS or for assistance, with water. The safety data sheet (SDS) contains more detailed occupational soap and water. If accidental eye exposure occurs, flush eyes immediately should be avoided. If accidental skin contact occurs, wash immediately with As with any topical medication intended for treatment of animals, skin contact cows or bulls. recommended dose had no adverse effect on breeding performance of showed clinical signs of mydriasis. Application 3 times the study, one of 6 cattle treated once at 10 times the recommended dose intervals had no adverse effects on 8 week old calves. In the tolerance application of up to 5 times the recommended dose 3 at 7 day recommended dose had no adverse effects on neonatal calves, and eprinomectin in cattle. In toxicity studies, application of 3 times the Tolerance and toxicity studies have demonstrated the margin of safety for ANIMAL SAFETY 990 lb (450 k 880 lb (4 0 770 lb (350 k 660 lb (3 0 550 lb (250 k 440 lb (2 0 exceed When the interval between use of applicator gun is expected to Container (84.5 fl oz/2.5 liter pa c and tubing ba c and cap from the product containe r compatibility problems resulting in lo c equ i gun manufacture r equipment to the outlet from vent cap. F The dra w Container (6 7 dose, and care of the applicator gun following use. vent cap pr o the shipping cap from ba c problems resulting in lo c recommended. Other applicato r The applicator gun from Simcro applicator gun following use. directions for priming the gun, adjusting dose, and care of applicator gun. to the spigot on F drum ensuring a tight fit. Connect the long 3m feed tube at one end lea k WARNING kpa c k cap and the other end to T s may exhibit compatibility age. k; valent, is recommended. Other applicato r e not use in calves to be processed for veal. period has not been established for pre-ruminating calves. Do consumption at any time following treatment. A withdrawal Eprizero (eprinomectin) Pour-On may be used for human is required, therefore, meat and milk from cattle treated with pre-slaughter drug withdrawal period nor a milk discard time When used according to label directions, neither a RESIDUE WARNINGS c 1 k container and replace with the , empty the product from gun rect dosage or lea k h, or equ i 69 fl oz/5 liter pa c 1 2 hou r 1 S 220 lb ( 1 -o f 1 king, inco r Keep this and all drugs out of the reach children. crew 0 0 lb (5 f device and applicator gun from Simcro vided. W 6 fl oz/20 liter container with dra w k into the container and replace shipping cap. eight Dose s, disconnect the gun, draw o f Then follow the applicator gun manufacture r ollow the applicator F valent, is f tubing and dip tube eedlot pa c 0 50 s may exhibit ’ s directions for priming the gun, adjusting 0 0 0 0 A 0 50 mL 45 mL 40 mL 35 mL 30 mL 25 mL 20 mL 1 1 -o f k k k k k rect dosage or t 0 mL 5 mL k eedlot pa c ta c NOT FOR USE IN HUMANS. g) g) g) g) g) g) g) g) g) f device) h the hose from automatic dosing king, inco r T k) e age. c k cap and dip tube onto the 20 liter h, or WARNING kpa c k cap and the other end to R T s may exhibit compatibility k; ’ s e em o c 1 k container and replace with the , empty the product from gun rect dosage or lea k h, or equ i 69 fl oz/5 liter pa c ve king, inco r ollow the applicator 121670I02 valent, is fly season may be re-treated with Eprizero ® Eprizero When to Treat Cattle with Grubs with products containing compounds of this class. Severe adverse reactions have been reported in other species treated Eprizero Pour-On is not recommended for use in species other than cattle. Do not apply to areas of the backline covered with mud or manure. injection. This product is for topical application only. Do not administer orally or by PRECAUTIONS Newry, BT35 6PU, Co. Down, Northern Ireland. Norbrook Laboratories Limited Manufactured by: Made in the UK. Restricted Drug (California) - Use Only as Directed. for use with appropriate automatic dosing equipment. 2.5 L/84.5 fl oz or 5 L/169 container 20 L/676 intended 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in HOW SUPPLIED short period of time, however, such exposure should be minimized. to 86° F/30° C. Storage at temperatures up 104°F/40°C is permitted for a Store container in the carton to protect from light and at temperatures up STORAGE CONDITIONS No adverse reactions were observed during clinical trials. ADVERSE REACTIONS adverse impact on populations of dung-dependent insects. according to label directions, the product is not expected have an duration of such effects are species and life-cycle specific. When used use dung as a source of food and for reproduction. The magnitude can inhibit the reproduction and growth of pest beneficial insects that avermectins, eprinomectin is excreted in the dung of treated animals and containers in an approved landfill or by incineration. As with other application or by the improper disposal of drug containers. Dispose least 6 hours after treatment. Do not contaminate water by direct organisms. Do not permit cattle to enter lakes, streams or ponds for at ivermectin/eprinomectin may adversely affect fish and certain aquatic readily and tightly binds to the soil becomes inactive over time. Free Studies indicate that when eprinomectin comes in contact with soil, it ENVIRONMENTAL SAFETY advice on a planned parasite control program, consult your veterinarian. without danger of grub-related reactions. For further information and grub development. Cattle treated with Eprizero paralysis. Cattle should be treated either before or after these stages of killing H. bovis when it is in the vertebral canal may cause staggering or Hypoderma lineatum when it is in the esophageal tissues may cause bloat; vital areas may cause undesirable host-parasite reactions. Killing of (warble fly) season. While this is not peculiar to eprinomectin, destruction cattle should be treated as soon possible after the end of heel fly proper timing of treatment is important. For the most effective results, f tubing and dip tube s may exhibit

Eprizero is a registered trademark of Norbrook Laboratories Limited. Hypoderma larvae (cattle grubs) at the period when these grubs are in 50 mL 45 mL 40 mL 35 mL 30 mL 25 mL 20 mL 1 1 -o f rect dosage or 0 mL 5 mL f device)

T Pour-On is effective against all stages of cattle grubs. However, k) e age. c h, or R ’ s em o ve 121670I02 fly season may be re-treated with Eprizero ® Eprizero When to Treat Cattle with Grubs with products containing compounds of this class. Severe adverse reactions have been reported in other species treated Eprizero Pour-On is not recommended for use in species other than cattle. Do not apply to areas of the backline covered with mud or manure. injection. This product is for topical application only. Do not administer orally or by PRECAUTIONS Newry, BT35 6PU, Co. Down, Northern Ireland. Norbrook Laboratories Limited Manufactured by: Made in the UK. Restricted Drug (California) - Use Only as Directed. for use with appropriate automatic dosing equipment. 2.5 L/84.5 fl oz or 5 L/169 container 20 L/676 intended 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in HOW SUPPLIED short period of time, however, such exposure should be minimized. to 86° F/30° C. Storage at temperatures up 104°F/40°C is permitted for a Store container in the carton to protect from light and at temperatures up STORAGE CONDITIONS No adverse reactions were observed during clinical trials. ADVERSE REACTIONS adverse impact on populations of dung-dependent insects. according to label directions, the product is not expected have an duration of such effects are species and life-cycle specific. When used use dung as a source of food and for reproduction. The magnitude can inhibit the reproduction and growth of pest beneficial insects that avermectins, eprinomectin is excreted in the dung of treated animals and containers in an approved landfill or by incineration. As with other application or by the improper disposal of drug containers. Dispose least 6 hours after treatment. Do not contaminate water by direct organisms. Do not permit cattle to enter lakes, streams or ponds for at ivermectin/eprinomectin may adversely affect fish and certain aquatic readily and tightly binds to the soil becomes inactive over time. Free Studies indicate that when eprinomectin comes in contact with soil, it ENVIRONMENTAL SAFETY advice on a planned parasite control program, consult your veterinarian. without danger of grub-related reactions. For further information and grub development. Cattle treated with Eprizero paralysis. Cattle should be treated either before or after these stages of killing H. bovis when it is in the vertebral canal may cause staggering or Hypoderma lineatum when it is in the esophageal tissues may cause bloat; vital areas may cause undesirable host-parasite reactions. Killing of (warble fly) season. While this is not peculiar to eprinomectin, destruction cattle should be treated as soon possible after the end of heel fly proper timing of treatment is important. For the most effective results,

Eprizero is a registered trademark of Norbrook Laboratories Limited. Hypoderma larvae (cattle grubs) at the period when these grubs are in

Pour-On is effective against all stages of cattle grubs. However,

Pour-On during the winter

Pour-On at the end of

Pour-On during the winter

Pour-On at the end of www.norbrook.com Norbrook logos and Eprizero are registered trademarks of Norbrook Laboratories Limited. Eprinex and Ivomec are registered trademarks of Merial. Cydectin is a registered trademark of Boehringer Ingelheim. Dectomax is a registered trademark of Zoetis. 1 Nodtvedt A, et al. Increase in milk yield following eprinomectin treatment at calving in pastured dairy cattle. Vet Parasitol. 2002;105:191-206. 2 McPherson WB, et. al. The impact of eprinomectin treatment on dairy cattle reproductive performance. Proceedings, 44th Annual Meeting American Association of Veterinary Pathologists. 1999; 41. 3 Paul A, Hutchens D, Hart D, Maciel AE, Robertson C, Gross SJ. Comparison of Eprinomectin with other macrocyclic lactones in cattle. Proceedings, 45th Annual Meeting of the American Association of Veterinary Parasitologists, Salt Lake City, Utah. 2000. 4 Cruthers L, Sloan R. Comparative efficacy of commercial pour-on parasiticides applied to wet cattle. Proceedings, 44th Annual Meeting of the American Association of Veterinary Pathologists, 1999, 29. 0518-563-I02A Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According To Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules And Regulations

Revision Date: 03/08/2016 Date of issue: 03/08/2016 Version: 1.0

SECTION 1: IDENTIFICATION 1.1. Product Identifier Product Form: Mixture Product Name: Eprizero Pour On for Beef and Dairy Cattle Product Code: ANADA 200-563 1.2. Intended Use of the Product Use of the substance/mixture: Eprizero Pour On is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. 1.3. Name, Address, and Telephone of the Responsible Party

Supplier Manufacturer Norbrook, Inc. Norbrook Laboratories Ltd, 9401 Indian Creek Parkway – Ste. 680 Station Works, Newry, Co.Down, Overland Park, KS 66210 N.Ireland, BT35 6JP. Phone: 913 599 5777 Telephone No. +44 (0)28 3026 4435 Fax: 913 599 5766 Fax No. +44 (0)28 3026 1721 E-Mail: [email protected] 1.4. Emergency Telephone Number

Emergency Number : 913 599 5777

SECTION 2: HAZARDS IDENTIFICATION 2.1. Classification of the Substance or Mixture GHS-US classification Repr. 2 H361 Lact. H362 Aquatic Acute 3 H402 Aquatic Chronic 3 H412 Full text of hazard classes and H-statements : see section 16 2.2. Label Elements GHS-US Labeling Hazard Pictograms (GHS-US) :

GHS08

Signal Word (GHS-US) : Warning Hazard Statements (GHS-US) : H361 - Suspected of damaging fertility or the unborn child. H362 - May cause harm to breast-fed children. H402 - Harmful to aquatic life. H412 - Harmful to aquatic life with long lasting effects. Precautionary Statements (GHS-US) : P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P260 - Do not breathe vapors, mist, or spray. P263 - Avoid contact during pregnancy/while nursing. P264 - Wash hands, forearms, and other exposed areas thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P280 - Wear protective gloves, protective clothing, and eye protection. P308+P313 - If exposed or concerned: Get medical advice/attention. P405 - Store locked up. P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations.

2.3. Other Hazards Exposure may aggravate those with pre-existing eye, skin, or respiratory conditions.

2.4. Unknown Acute Toxicity (GHS-US) No data available

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Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet

According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.1. Substance Not applicable 3.2. Mixture Name Product Identifier % GHS-US classification 1,2-Propylene glycol (CAS No) 57-55-6 Proprietary Not classified Eprinomectin (CAS No) 123997-26-2 Proprietary Acute Tox. 3 (Oral), H301 Lact., H362 Repr. 2, H361 STOT RE 2, H373 Aquatic Acute 1, H400 Aquatic Chronic 1, H410 2,6-Di-tert-butyl-p-cresol (CAS No) 128-37-0 Proprietary Aquatic Acute 1, H400 Aquatic Chronic 1, H410 The specific chemical identity and/or exact percentage of composition have been withheld as a trade secret [29 CFR 1910.1200]. Full text of H-phrases: see section 16 SECTION 4: FIRST AID MEASURES 4.1. Description of First Aid Measures First-aid Measures General: Never give anything by mouth to an unconscious person. If you feel unwell, seek medical advice (show the label if possible). First-aid Measures After Inhalation: Remove to fresh air and keep at rest in a position comfortable for breathing. Obtain medical attention if breathing difficulty persists. First-aid Measures After Skin Contact: Remove contaminated clothing. Gently wash with plenty of soap and water followed by rinsing with water for at least 15 minutes. Call a POISON CENTER or doctor/physician if you feel unwell. Wash contaminated clothing before reuse. First-aid Measures After Eye Contact: Rinse cautiously with water for at least 15 minutes. Remove contact lenses, if present and easy to do so. Continue rinsing. Obtain medical attention if irritation persists. First-aid Measures After Ingestion: Do NOT induce vomiting. Rinse mouth. Immediately call a POISON CENTER or doctor/physician. 4.2. Most important symptoms and effects, both acute and delayed Symptoms/Injuries: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. Please refer to the package insert for more detailed information. Symptoms/Injuries After Inhalation: May cause drowsiness or dizziness. Symptoms/Injuries After Skin Contact: May cause skin irritation. Symptoms/Injuries After Eye Contact: May cause eye irritation. Symptoms/Injuries After Ingestion: Ingestion is likely to be harmful or have adverse effects. Chronic Symptoms: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. 4.3. Indication of Any Immediate Medical Attention and Special Treatment Needed If you feel unwell, seek medical advice (show the label where possible).

SECTION 5: FIRE-FIGHTING MEASURES 5.1. Extinguishing Media Suitable Extinguishing Media: Use extinguishing media appropriate for surrounding fire. Unsuitable Extinguishing Media: None known. 5.2. Special Hazards Arising From the Substance or Mixture Fire Hazard: Not flammable. Explosion Hazard: Product is not explosive. Reactivity: Hazardous reactions will not occur under normal conditions. 5.3. Advice for Firefighters Precautionary Measures Fire: Exercise caution when fighting any chemical fire. Under fire conditions, hazardous fumes will be present. Firefighting Instructions: Use water spray or fog for cooling exposed containers. Prevent fire-fighting water from entering environment. Protection During Firefighting: Do not enter fire area without proper protective equipment, including respiratory protection.

03/08/2016 EN (English US) 2/6

Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet

According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

SECTION 6: ACCIDENTAL RELEASE MEASURES 6.1. Personal Precautions, Protective Equipment and Emergency Procedures General Measures: Use only as directed. Avoid all contact with skin, eyes, or clothing. Avoid breathing vapor, mist, or spray. 6.1.1. For Non-emergency Personnel Protective Equipment: Use appropriate personal protection equipment (PPE). Emergency Procedures: Evacuate unnecessary personnel. 6.1.2. For Emergency Responders Protective Equipment: Equip cleanup crew with proper protection. Emergency Procedures: Upon arrival at the scene, a first responder is expected to recognize the presence of dangerous goods, protect oneself and the public, secure the area, and call for the assistance of trained personnel as soon as conditions permit. 6.2. Environmental Precautions Avoid release to the environment. 6.3. Methods and Material for Containment and Cleaning Up For Containment: Contain any spills with dikes or absorbents to prevent migration and entry into sewers or streams. Methods for Cleaning Up: Clean up spills immediately and dispose of waste safely. Absorb and/or contain spill with inert material, then place in suitable container. Use only non-sparking tools. Do not take up in combustible material such as: saw dust or cellulosic material. 6.4. Reference to Other Sections See Heading 8. Exposure controls and personal protection. For further information refer to section 13.

SECTION 7: HANDLING AND STORAGE 7.1. Precautions for Safe Handling Precautions for Safe Handling: Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Hygiene Measures: Handle in accordance with good industrial hygiene and safety procedures. Wash hands and other exposed areas with mild soap and water before eating, drinking, or smoking and again when leaving work. 7.2. Conditions for Safe Storage, Including Any Incompatibilities Technical Measures: Comply with applicable regulations. Storage Conditions: Store in a dry, cool and well-ventilated place. Store locked up. Keep container closed when not in use. Keep/Store away from direct sunlight, extremely high or low temperatures and incompatible materials. Incompatible Products: Strong acids, strong bases, strong oxidizers. Storage Temperature: 30 °C Max 7.3. Specific End Use(s) Eprizero Pour On is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control Parameters For substances listed in section 3 that are not listed here, there are no established exposure limits from the manufacturer, supplier, importer, or the appropriate advisory agency including: ACGIH (TLV), AIHA (WEEL), NIOSH (REL), or OSHA (PEL).

2,6-Di-tert-butyl-p-cresol (128-37-0) USA ACGIH ACGIH TWA (mg/m³) 2 mg/m³ (inhalable fraction and vapor) USA ACGIH ACGIH chemical category Not Classifiable as a Human Carcinogen USA NIOSH NIOSH REL (TWA) (mg/m³) 10 mg/m³

1,2-Propylene glycol (57-55-6) USA AIHA WEEL TWA (mg/m³) 10 mg/m³

8.2. Exposure Controls Appropriate Engineering Controls : Ensure adequate ventilation, especially in confined areas. Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure. Ensure all national/local regulations are observed. Personal Protective Equipment : Avoid all unnecessary exposure. Gloves. Protective clothing. Protective goggles. Insufficient ventilation: wear respiratory protection.

03/08/2016 EN (English US) 3/6

Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet

According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

Materials for Protective Clothing : Chemically resistant materials and fabrics. Hand Protection : Wear chemically resistant protective gloves. Eye Protection : Chemical safety goggles. Skin and Body Protection : Wear suitable protective clothing. Wash contaminated clothing before reuse. Respiratory Protection : In case of inadequate ventilation, oxygen deficient atmosphere, or where exposure levels are not known wear approved respiratory protection. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on Basic Physical and Chemical Properties Physical State : Liquid

Appearance : Clear solution

Odor : No data available

Odor Threshold : No data available

pH : No data available

Evaporation Rate : No data available

Melting Point : No data available

Freezing Point : No data available

Boiling Point : No data available

Flash Point : No data available

Auto-ignition Temperature : No data available

Decomposition Temperature : No data available

Flammability (solid, gas) : No data available

Vapor Pressure : No data available

Relative Vapor Density at 20 °C : No data available

Relative Density : No data available

Solubility : No data available

Partition Coefficient: N-Octanol/Water : No data available

Viscosity : No data available

9.2. Other Information No additional information available SECTION 10: STABILITY AND REACTIVITY 10.1. Reactivity: Hazardous reactions will not occur under normal conditions.

10.2. Chemical Stability: Stable at standard temperature and pressure.

10.3. Possibility of Hazardous Reactions: Hazardous polymerization will not occur.

10.4. Conditions to Avoid: Direct sunlight, extremely high or low temperatures, and incompatible materials.

10.5. Incompatible Materials: Strong acids, strong bases, strong oxidizers.

10.6. Hazardous Decomposition Products: Thermal decomposition generates: Carbon oxides (CO, CO2). Nitrogen oxides.

SECTION 11: TOXICOLOGICAL INFORMATION 11.1. Information On Toxicological Effects Acute Toxicity: Not classified

Eprinomectin (123997-26-2) LD50 Oral Rat 55 mg/kg

2,6-Di-tert-butyl-p-cresol (128-37-0) LD50 Oral Rat > 2930 mg/kg (Species: Sprague-Dawley) LD50 Dermal Rat > 2000 mg/kg

1,2-Propylene glycol (57-55-6) LD50 Oral Rat 20 g/kg LD50 Dermal Rabbit 20800 mg/kg

Skin Corrosion/Irritation: Not classified

Serious Eye Damage/Irritation: Not classified

Respiratory or Skin Sensitization: Not classified Germ Cell Mutagenicity: Not classified Carcinogenicity: Not classified

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Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet

According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

2,6-Di-tert-butyl-p-cresol (128-37-0) IARC group 3

Reproductive Toxicity: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. Specific Target Organ Toxicity (Single Exposure): Not classified

Specific Target Organ Toxicity (Repeated Exposure): Not classified

Aspiration Hazard: Not classified Symptoms/Injuries After Inhalation: May cause drowsiness or dizziness. Symptoms/Injuries After Skin Contact: May cause skin irritation. Symptoms/Injuries After Eye Contact: May cause eye irritation. Symptoms/Injuries After Ingestion: Ingestion is likely to be harmful or have adverse effects. Chronic Symptoms: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. SECTION 12: ECOLOGICAL INFORMATION 12.1. Toxicity Ecology - General : Harmful to aquatic life. Harmful to aquatic life with long lasting effects.

2,6-Di-tert-butyl-p-cresol (128-37-0) EC50 Other Aquatic Organisms 2 0.43 mg/l (Exposure time: 72 h - Species: Desmodesmus subspicatus)

1,2-Propylene glycol (57-55-6) LC50 Fish 1 51600 mg/l (Exposure time: 96 h - Species: Oncorhynchus mykiss [static]) EC50 Daphnia 1 10000 mg/l (Exposure time: 24 h - Species: Daphnia magna) LC 50 Fish 2 41 - 47 ml/l (Exposure time: 96 h - Species: Oncorhynchus mykiss [static]) EC50 Daphnia 2 1000 mg/l (Exposure time: 48 h - Species: Daphnia magna [Static])

12.2. Persistence and Degradability No additional information available

12.3. Bioaccumulative Potential 2,6-Di-tert-butyl-p-cresol (128-37-0) BCF fish 1 230 - 2500 Log Pow 4.17

1,2-Propylene glycol (57-55-6) BCF fish 1 < 1 Log Pow -0.92

12.4. Mobility in Soil No additional information available

12.5. Other Adverse Effects Other Information : Avoid release to the environment.

SECTION 13: DISPOSAL CONSIDERATIONS 13.1. Waste treatment methods Sewage Disposal Recommendations: This material is hazardous to the aquatic environment. Keep out of sewers and waterways. Waste Disposal Recommendations: Dispose of waste material in accordance with all local, regional, national, and international regulations. Additional Information: Contaminated sharps should be handled with care and discarded immediately or as soon as possible in containers that are closable, puncture-resistant, leak proof on sides and bottoms, and appropriately labeled. Contact your local health department for referral to a syringe disposal program. In hospital and workplace settings, contaminated sharps are to be handled in accordance with EC Directive 2010/32/EU. SECTION 14: TRANSPORT INFORMATION 14.1. In Accordance with DOT Not regulated for transport 14.2. In Accordance with IMDG Not regulated for transport 14.3. In Accordance with IATA Not regulated for transport

SECTION 15: REGULATORY INFORMATION 15.1 US Federal Regulations Eprizero Pour On for Beef and Dairy Cattle SARA Section 311/312 Hazard Classes Delayed (chronic) health hazard

2,6-Di-tert-butyl-p-cresol (128-37-0) Listed on the United States TSCA (Toxic Substances Control Act) inventory

1,2-Propylene glycol (57-55-6) Listed on the United States TSCA (Toxic Substances Control Act) inventory

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Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet

According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

EPA TSCA Regulatory Flag Y2 - Y2 - indicates an exempt polymer that is a polyester and is made only from reactants included in a specified list of low concern reactants that comprises one of the eligibility criteria for the exemption rule

15.2 US State Regulations 2,6-Di-tert-butyl-p-cresol (128-37-0) U.S. - Massachusetts - Right To Know List U.S. - New Jersey - Right to Know Hazardous Substance List U.S. - Pennsylvania - RTK (Right to Know) List

1,2-Propylene glycol (57-55-6) U.S. - New Jersey - Right to Know Hazardous Substance List U.S. - Pennsylvania - RTK (Right to Know) List

SECTION 16: OTHER INFORMATION, INCLUDING DATE OF PREPARATION OR LAST REVISION

Revision Date : 03/08/2016 Other Information : This document has been prepared in accordance with the SDS requirements of the OSHA Hazard Communication Standard 29 CFR 1910.1200.

GHS Full Text Phrases: ------Acute Tox. 3 (Oral) Acute toxicity (oral) Category 3 ------Aquatic Acute 1 Hazardous to the aquatic environment - Acute Hazard Category 1 ------Aquatic Acute 3 Hazardous to the aquatic environment - Acute Hazard Category 3 ------Aquatic Chronic 1 Hazardous to the aquatic environment - Chronic Hazard Category 1 ------Aquatic Chronic 3 Hazardous to the aquatic environment - Chronic Hazard Category 3 ------Lact. Reproductive toxicity (Lact.) ------Repr. 2 Reproductive toxicity Category 2 ------STOT RE 2 Specific target organ toxicity (repeated exposure) Category 2 ------H301 Toxic if swallowed ------H361 Suspected of damaging fertility or the unborn child ------H362 May cause harm to breast-fed children ------H373 May cause damage to organs through prolonged or repeated exposure ------H400 Very toxic to aquatic life ------H402 Harmful to aquatic life ------H410 Very toxic to aquatic life with long lasting effects ------H412 Harmful to aquatic life with long lasting effects

This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product.

SDS US (GHS HazCom)

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