# 520.1198 Ivermectin and praziquantel paste.
(a) *Specifications.* 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.
(b) *Sponsors.* 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.
(c) *Special considerations.* See § 500.25 of this chapter.
(d) *Conditions of use in horses*—(1) *Amount.* (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).
(2) *Indications for use.* (i) For treatment and control of the following parasites: Tapeworms—*Anoplocephala perfoliata;* Large Strongyles (adults)—*Strongylus vulgaris* (also early forms in blood vessels), *S. edentatus* (also tissue stages), *S. equinus, Triodontophorus* spp. Including *T. brevicauda* and *T. serratus,* and *Craterostomum acuticaudatum;* Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—*Coronocyclus* spp. Including *C. coronatus, C. labiatus,* and *C. labratus; Cyathostomum* spp. Including *C. catinatum* and *C. pateratum; Cylicocyclus* spp. Including *C. insigne, C. leptostomum,* *C. nassatus,* and *C. brevicapsulatus; Cylicodontophorus* spp.; *Cylicostephanus* spp. Including *C. calicatus, C. goldi,* *C. longibursatus,* and *C. minutus,* and *Petrovinema poculatum;* Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—*Oxyuris equi;* Ascarids (adults and third- and fourth-stage larvae)—*Parascaris equorum;* Hairworms (adults)—*Trichostrongylus axei;* Large-mouth Stomach Worms (adults)—*Habronema muscae;* Bots (oral and gastric stages)—*Gasterophilus* spp. Including *G. intestinalis* and *G. nasalis;* Lungworms (adults and fourth-stage larvae)—*Dictyocaulus arnfieldi;* Intestinal Threadworms (adults)—*Strongyloides westeri;* Summer Sores caused by *Habronema* and *Draschia* spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of *Onchocerca* sp.
(ii) For treatment and control of the following parasites: Tapeworms—*Anoplocephala perfoliata;* Large Strongyles (adults)—*Strongylus vulgaris* (also early forms in blood vessels), *S. edentatus* (also tissue stages), *S. equinus, Triodontophorus* spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—*Cyathostomum* spp.; *Cylicocyclus* spp.; *Cylicostephanus* spp., *Cylicodontophorus* spp.; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—*Oxyuris equi;* Ascarids (adults and third- and fourth-stage larvae)—*Parascaris equorum;* Hairworms (adults)—*Trichostrongylus axei;* Large-mouth Stomach Worms (adults)—*Habronema muscae;* Bots (oral and gastric stages)—*Gasterophilus* spp.; Lungworms (adults and fourth-stage larvae)—*Dictyocaulus arnfieldi;* Intestinal Threadworms (adults)—*Strongyloides westeri;* Summer Sores caused by *Habronema* and *Draschia* spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, *Onchocerca* sp.
(iii) For treatment and control of the following parasites in horses over 5 months of age: Tapeworms—*Anoplocephala perfoliata;* Large Strongyles (adults)—*Strongylus vulgaris* (also early forms in blood vessels), *S. edentatus* (also tissue stages), *S. equinus, Triodontophorus* spp. Including *T. brevicauda* and *T. serratus,* and *Craterostomum acuticaudatum;* Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—*Coronocyclus* spp. Including *C. coronatus, C. labiatus,* and *C. labratus; Cyathostomum* spp. Including *C. catinatum* and *C. pateratum; Cylicocyclus* spp. including *C. insigne, C. leptostomum,* *C. nassatus,* and *C. brevicapsulatus; Cylicodontophorus* spp.; *Cylicostephanus* spp. including *C. calicatus, C. goldi,* *C. longibursatus,* and *C. minutus,* and *Petrovinema poculatum;* Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—*Oxyuris equi;* Ascarids (adults and third- and fourth-stage larvae)—*Parascaris equorum;* Hairworms (adults)—*Trichostrongylus axei;* Large-mouth Stomach Worms (adults)—*Habronema muscae;* Bots (oral and gastric stages)—*Gasterophilus* spp. including *G. intestinalis* and *G. nasalis;* Lungworms (adults and fourth-stage larvae)—*Dictyocaulus arnfieldi;* Intestinal Threadworms (adults)—*Strongyloides westeri;* Summer Sores caused by *Habronema* and *Draschia* spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of *Onchocerca* sp.
(3) *Limitations.* 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]