[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1451]

[Page 305]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 524.1451   Moxidectin.

    (a) Specifications. Each milliliter contains 5 milligrams of 
moxidectin (0.5 percent solution).
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.426 of this chapter.
    (d) 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), Trichostrongylus axei (adult and L4), T. 
colubriformis (adult), Cooperia oncophora (adult), C. punctata (adult), 
Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult), 
Nematodirus helvetianus (adult)); 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, 
Damalinia bovis); and horn flies (Haematobia irritans). To control 
infections and to protect from reinfection with O. ostertagi for 28 days 
after treatment and with 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. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000]