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Proprietary Name	Cydectin® (moxidectin) 0.5% Pour-On for Beef and Dairy Cattle Cydectin® Pour-On for Cattle
NADA Number: 141-099
Sponsor	Fort Dodge Animal Health, Division of Wyeth
Sponsor Address	800 Fifth Street NW Fort Dodge, IA 50501 USA
Ingredients	Moxidectin
Species	Cattle, beef Cattle, calves, excluding veal calves Cattle, dairy, not breeding age
Routes of Administration	Topical
Dose Form	Liquid (solution)
Drug Form	Liquid (solution)
Dispensing Status	OTC
Patent Number	4916154 6514951
Exclusivity	Granted for the addition of a zero-day milk discard time and, thus, the removal of the warning statement for female dairy cattle of breeding age. Used topically as a 0.5% moxidectin solution on dairy cattle of breeding age for treatment and control of infections and infestations of certain internal and external parasites. Granted for topical use of a 0.5% moxidectin solution on dairy cattle of breeding age for treatment and control of additional life stages of certain internal and external parasites. Granted for the use of a new ingredient in dairy and beef cattle for treatment of certain internal and external parasites.
Withdrawal Time	Cattle: zero days before slaughter. A withdrawal time for pre-ruminating veal calves has not been established. Milk: zero days.
Dosage Amount, Indications & Limitations	524.1451 Moxidectin. Specifications: Each milliliter contains 5 milligrams of moxidectin (0.5 percent solution). Conditions of use: Cattle (beef and dairy) Amount: Each milliliter contains 5 milligrams of moxidectin (0.5 percent solution). Indications: For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus, adult and L4); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola(Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment. Limitations: A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal. Special considerations: The Commissioner of Food and Drugs has determined that, in order to assure that anthelmintic drugs, including animal feeds bearing or containing such drugs, which do not carry the prescription statement are labeled to provide adequate directions for their effective use, labeling of these anthelmintic drugs shall bear, in addition to other required information, a statement that a veterinarian should be consulted for assistance in the diagnosis, treatment, and control of parasitism. (b) The label and any labeling furnishing or purporting to furnish directions for use, shall bear conspicuously the following statement ``Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.'' (c) For drugs covered by approved new animal drug applications, the labeling revisions required for compliance with this section may be placed into effect without prior approval as provided for in Sec. 514.8 (d) and (e) of this chapter. For animal feeds bearing or containing anthelmintic drugs covered by approved applications, the labeling revisions required for compliance with this section may be placed into effect without the submission of supplemental applications as provided for in Sec. 514.9 of this chapter. (d) Labeling revisions required for compliance with this section shall be placed into effect by February 25, 1975, following which, any such drugs that are introduced into interstate commerce and not in compliance with this section will be subject to regulatory proceedings.
Tolerances	The tolerance for parent moxidectin (the marker residue) in edible tissues of cattle is 200 parts per billion (ppb) in liver (the target tissue) and 50 ppb in muscle. The tolerance for parent moxidectin is 40 ppb in milk.