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21 C.F.R. § 524.1451   Moxidectin.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 524.1451   Moxidectin.

(a) Specifications. Each milliliter contains 5 milligrams of moxidectin (0.5 percent solution).

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.426 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use–(1) Amount. 0.5 milligrams moxidectin per kilogram (2.2 pounds) of body weight.

(2) Indications for use. Beef and dairy cattle: 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.

(3) Limitations. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, 2001]

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