§ 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]