[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: 21CFR524.1193]

[Page 304-305]
 
                        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.  524.1193  Ivermectin pour-on.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams of ivermectin.
    (b) Sponsors. See Nos. 050604, 051259, 051311, 058829, 059130, and 
066916 in Sec.  510.600(c) of this chapter for use as in paragraph (e) 
of this section.
    (c) Related tolerances. See Sec.  556.344 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use. (1) Amount. One mL per 22 pounds of body 
weight.
    (2) Indications for use in cattle. It is used topically for the 
treatment and control of: Gastrointestinal roundworms (adults and 
fourth-stage

[[Page 305]]

larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus 
placei, Trichostrongylus axei, T. colubriformis, Cooperia spp., 
Oesophagostomum radiatum; (adults) O. venulosum, Strongyloides 
papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) 
Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, 
H. lineatum; mites Chorioptes bovis, Sarcoptes scabei var. bovis; lice 
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, 
Solenoptes capillatus; horn flies Haematobia irritans. It is also used 
to control infections of gastrointestinal roundworms O. ostertagi, O. 
radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 
days after treatment.
    (3) Limitations. Do not treat cattle within 48 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age.

[55 FR 50551, Dec. 7, 1990, as amended at 62 FR 38908, July 21, 1997; 62 
FR 63271, Nov. 28, 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, Mar. 
5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR 3817, Jan. 27, 2003; 68 FR 
4713, Jan. 30, 2003]