§ 520.1453 Moxidectin and praziquantel gel.

Specifications.(a) Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.

Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.

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

Conditions of use in horses and poniesAmount.(d) —(1) Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight.

Indications for use.Strongylus vulgarisS.edentatusTriodontophorus brevicaudaT.serratusCyathostomumC. catinatumC. pateratumCylicocyclusC. insigne, C. leptostomum, C. nassatusC. radiatusCylicostephanusC. calicatus, C. goldi, C. longibursatus,C. minutusCoronocyclusC. coronatus, C. labiatus,C. labratusGyalocephalus capitatusPetrovinema poculatusParascaris equorumOxyuris equiTrichostrongylus axeiHabronema muscaeGasterophilus intestinalisG.nasalisAnoplocephala perfoliata(2) For the treatment and control of large strongyles: (adults and L4/L5 arterial stages), (adult and tissue stages), (adults), and (adults); small strongyles (adults): ( spp., including and ; spp., including , and ; spp., including and ; spp., including and ; ; and ; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: (adults and L4 larval stages); pinworms: (adults and L4 larval stages); hairworms: (adults); large-mouth stomach worms: (adults); horse stomach bots: (2nd and 3rd instars) and (3rd instars); and tapeworms: (adults). One dose also suppresses strongyle egg production for 84 days.

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

[68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014]