[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1451]

[Page 307-308]
 
                        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) Special considerations. See Sec.  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

[[Page 308]]

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]