[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1193]

[Page 306]
 
                        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 sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 050604 for use as in paragraphs (e)(1), (e)(2)(i), 
(e)(2)(iii), and (e)(3) of this section.
    (2) Nos. 051259, 051311, 058829, 059130, and 066916 for use as in 
paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and (e)(3) 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 in cattle--(1) Amount. One mL per 22 pounds 
(0.5 milligram per kilogram) of body weight applied topically to the 
back of the animal.
    (2) Indications for use--(i) It is used for the treatment and 
control of: Gastrointestinal roundworms (adults and fourth-stage larvae) 
Ostertagia ostertagi (including inhibited stage), Haemonchus placei, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. surnabada, Oesophagostomum radiatum; (adults) Strongyloides 
papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) 
Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, 
H. lineatum; mites Sarcoptes scabei var. bovis; lice Linognathus vituli, 
Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; and 
horn flies Haematobia irritans.
    (ii) It controls infections and prevents reinfection with O. 
ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C. 
oncophora for 14 days after treatment.
    (iii) It controls infections and prevents reinfection with O. 
radiatum and D. viviparus for 28 days after treatment, C. punctata and 
T. axei for 21 days after treatment, H. placei, C. oncophora, and C. 
surnabada for 14 days after treatment, and D. bovis for 56 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. A withdrawal period has not been 
established for this product on preruminating calves. Do not use on 
calves to be processed for veal.

[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; 69 FR 501, Jan. 6, 2004]

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