21 CFR 524.1193 - Ivermectin topical solution.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Part 524 [§ 524.86 - § 524.2620]

§ 524.1193 - Ivermectin topical solution.

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

(b) Sponsors. See Nos. 000010, 016592, 055529, 058829, and 061133 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(d) 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. 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. 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. Do not use on female dairy cattle of breeding age or on calves to be processed for veal. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[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; 89 FR 42360, May 15, 2024]

authority: 21 U.S.C. 360b.

source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 524.1193