CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1193]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1193 Ivermectin topical solution.

(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams of ivermectin.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) Nos. 000010, 055529, 058829, 061133 for use as in paragraphs (e)(1), (e)(2)(i), (e)(2)(iii), and (e)(3) of this section.

(2) No. 016592, for use as in paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and (e)(3) of this section.

(c) Related tolerances. See § 556.344 of this chapter.

(d) Special considerations. See § 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 scabiei 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, O. ostertagi , 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; 69 FR 62181, Oct. 25, 2004; 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013; 81 FR 25328, Apr. 28, 2016; 83 FR 13635, Mar. 30, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 86 FR 13185, Mar. 8, 2021; 88 FR 84701, Dec. 6, 2023]