§ 520.1198 Ivermectin and praziquantel paste.

Specifications.(a) Each milligram (mg) of paste contains:

(1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel.

(2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel.

Sponsors.(b) See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.—

(1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section.

(2) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section.

Special considerations.(c) See § 500.25 of this chapter.

Conditions of use in horsesAmount.(d) —(1) (i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight.

(ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight.

(iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel (1.14 mg/lb).

Indications for use.Anoplocephala perfoliata;Strongylus vulgarisS. edentatusS. equinus, TriodontophorusT. brevicaudaT. serratus,Craterostomum acuticaudatum;CoronocyclusC. coronatus, C. labiatus,C. labratus; CyathostomumC. catinatumC. pateratum; CylicocyclusC. insigne, C. leptostomum,C. nassatus,C. brevicapsulatus; CylicodontophorusCylicostephanusC. calicatus, C. goldi,C. longibursatus,C. minutus,Petrovinema poculatum;Oxyuris equi;Parascaris equorum;Trichostrongylus axei;Habronema muscae;GasterophilusG. intestinalisG. nasalis;Dictyocaulus arnfieldi;Strongyloides westeri;HabronemaDraschiaOnchocerca(2) (i) For treatment and control of the following parasites: Tapeworms— Large Strongyles (adults)— (also early forms in blood vessels), (also tissue stages), spp. Including and and Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— spp. Including and spp. Including and spp. Including and spp.; spp. Including and and Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Ascarids (adults and third- and fourth-stage larvae)— Hairworms (adults)— Large-mouth Stomach Worms (adults)— Bots (oral and gastric stages)— spp. Including and Lungworms (adults and fourth-stage larvae)— Intestinal Threadworms (adults)— Summer Sores caused by and spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of sp.

Anoplocephala perfoliata;Strongylus vulgarisS. edentatusS. equinus, TriodontophorusCyathostomumCylicocyclusCylicostephanusCylicodontophorusOxyuris equi;Parascaris equorum;Trichostrongylus axei;Habronema muscae;GasterophilusDictyocaulus arnfieldi;Strongyloides westeri;HabronemaDraschiaOnchocerca(ii) For treatment and control of the following parasites: Tapeworms— Large Strongyles (adults)— (also early forms in blood vessels), (also tissue stages), spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— spp.; spp.; spp., spp.; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Ascarids (adults and third- and fourth-stage larvae)— Hairworms (adults)— Large-mouth Stomach Worms (adults)— Bots (oral and gastric stages)— spp.; Lungworms (adults and fourth-stage larvae)— Intestinal Threadworms (adults)— Summer Sores caused by and spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, sp.

Anoplocephala perfoliata;Strongylus vulgarisS. edentatusS. equinus, TriodontophorusT. brevicaudaT. serratus,Craterostomum acuticaudatum;CoronocyclusC. coronatus, C. labiatus,C. labratus; CyathostomumC. catinatumC. pateratum; CylicocyclusC. insigne, C. leptostomum,C. nassatus,C. brevicapsulatus; CylicodontophorusCylicostephanusC. calicatus, C. goldi,C. longibursatus,C. minutus,Petrovinema poculatum;Oxyuris equi;Parascaris equorum;Trichostrongylus axei;Habronema muscae;GasterophilusG. intestinalisG. nasalis;Dictyocaulus arnfieldi;Strongyloides westeri;HabronemaDraschiaOnchocerca(iii) For treatment and control of the following parasites in horses over 5 months of age: Tapeworms— Large Strongyles (adults)— (also early forms in blood vessels), (also tissue stages), spp. Including and and Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— spp. Including and spp. Including and spp. including and spp.; spp. including and and Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Ascarids (adults and third- and fourth-stage larvae)— Hairworms (adults)— Large-mouth Stomach Worms (adults)— Bots (oral and gastric stages)— spp. including and Lungworms (adults and fourth-stage larvae)— Intestinal Threadworms (adults)— Summer Sores caused by and spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of sp.

Limitations.(3) For oral use only. Do not use in horses intended for human consumption.

[68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014; 84 FR 39183, Aug. 9, 2019; 89 FR 42357, May 15, 2024]