--- kind: "section" citation: "21 C.F.R. § 520.1198" title: "21" number: "520.1198" heading: "Ivermectin and praziquantel paste." url: "https://uscodex.org/cfr/21/520.1198" --- # §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)](/cfr/21/510.600.md?p=c) of this chapter for uses as in [paragraph (d)](#d) of this section.— - (1) **No.** 000010 for use of product described in [paragraph (a)(1)](#a-1) of this section as in paragraphs [(d)(1)(i)](#d-1-i), [(d)(2)(i)](#d-2-i) and (d)(3) of this section. - (2) **No.** 051311 for use of product described in [paragraph (a)(2)](#a-2) of this section as in paragraphs [(d)(1)(ii)](#d-1-ii), [(d)(2)(ii)](#d-2-ii), and (d)(3) of this section. - (c) **Special considerations.** See [§ 500.25](/cfr/21/500.25.md) 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. ## Notes ### Amendments [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] ### Authority Authority: 21 U.S.C. 360b. ### Source Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted. ### Amendments [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]