Food and Drug Administration, HHS § 520.1450b

(3) 11.5 mg milbemycin oxime, 230 mg spp.), and worms of the large intestine lufenuron, and 114 mg praziquantel; or (Oesophagostomum radiatum). (4) 23 mg milbemycin oxime, 460 mg (3) Limitations. Conditions of constant lufenuron, and 228 mg praziquantel. worm exposure may require retreat- (b) Sponsor. See No. 058198 in ment in 2 to 4 weeks. Consult your vet- § 510.600(c) of this chapter. erinarian before administering to se- (c) [Reserved] verely debilitated and for as- (d) Conditions of use—(1) —(i) sistance in the diagnosis, treatment, Amount. 0.5 mg milbemycin oxime, 10 and control of parasitism. Do not treat mg lufenuron, and 5 mg of praziquantel within 14 days of slaughter. per kilogram of body weight, once a month. [46 FR 50949, Oct. 16, 1981. Redesignated at 49 (ii) Indications for use. For the pre- FR 47831, Dec. 7, 1984, and amended at 51 FR vention of heartworm disease caused 9005, Mar. 17, 1986] by Dirofilaria immitis; for the prevention and control of flea populations § 520.1450b Morantel tartrate car- (Ctenocephalides felis); and for the treat- tridge. ment and control of adult roundworm (a) Specifications. The drug product (, ), consists of a stainless-steel cylinder adult (Ancylostoma having both ends closed with poly- caninum), adult whipworm (Trichuris ethylene diffusing discs and containing vulpis), and adult tapeworm (Taenia a morantel tartrate paste. The paste pisiformis, Echinococcus multilocularis, contains 22.7 grams of morantel tar- and E. granulosus) infections in dogs trate equivalent to 13.5 grams of and puppies 2 pounds of body weight or morantel base. greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 000069 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.425 of (2) [Reserved] this chapter. (d) Conditions of use—(1) Amount. [77 FR 4225, Jan. 27, 2012] Grazing cattle: Administer 1 cartridge § 520.1450 Morantel tartrate oral dos- to each at the start of the graz- age forms. ing season. (2) Indications for use. For control of § 520.1450a Morantel tartrate bolus. the adult stage of the following gastro- (a) Specifications. Each bolus contains intestinal infections in 2.2 grams morantel tartrate equivalent weaned calves and yearling cattle to 1.3 grams of morantel base. weighing a minimum of 200 pounds: (b) Sponsor. See No. 000069 in Ostertagia spp., axei, § 510.600(c) of this chapter. Cooperia spp., and Oesophagostomum (c) Related tolerances. See § 556.425 of radiatum. this chapter. (3) Limitations. Administer orally (d) Conditions of use—(1) Amount. One with the dosing gun to all cattle that bolus per 500 pounds of body weight (4.4 will be grazing the same pasture. Effec- milligrams per pound of body weight) tiveness of the drug product is depend- as a single oral dose. Boluses may be ent upon continuous control of the gas- divided in half for more accurate dos- trointestinal parasites for approxi- ing as follows: up to 325 pounds, 1⁄2 bolus; 326 to 600 pounds, 1 bolus; 601 to mately 90 days following administra- tion. Therefore, treated cattle should 900 pounds, 11⁄2 boluses; and 901 to 1,200 pounds, 2 boluses. not be moved to pastures grazed in the (2) Indications for use. For removal same grazing season/calendar year by and control of mature gastrointestinal untreated cattle. Do not administer to nematode infections of cattle including cattle within 106 days of slaughter. stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the (Cooperia spp., Trichostrongylus spp., Nematodirus

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Consult your veterinarian before ad- (b) Sponsor. See No. 000856 in ministering to severely debilitated ani- § 510.600(c) of this chapter. mals and for assistance in the diag- (c) [Reserved] nosis, treatment, and control of para- (d) Conditions of use—(1) Amount. 3 sitism. micrograms per kilogram (1.36 [49 FR 47831, Dec. 7, 1984, as amended at 51 micrograms per pound) of body weight. FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, (2) Indications for use. To prevent in- 1986] fection by the canine heartworm Dirofilaria immitis and the subsequent § 520.1450c Morantel tartrate sus- development of canine heartworm dis- tained-release trilaminate cylinder/ ease. sheet. (3) Limitations. Use once-a-month in (a) Specifications. The drug product dogs at 8 weeks of age or older. Federal consists of a trilaminated, perforated, law restricts this drug to use by or on plastic sheet formed into a cylinder the order of a licensed veterinarian. having plastic plugs in its ends. The [62 FR 37713, July 15, 1997] core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 § 520.1452 Moxidectin gel. grams of morantel base. (b) Sponsor. See 000069 in § 510.600(c) of (a) Specifications. Each milliliter of this chapter. gel contains 20 milligrams (2 percent) (c) Related tolerances. See § 556.425 of moxidectin. this chapter. (b) Sponsor. See No. 000856 in (d) Conditions of use—(1) Amount. § 510.600(c) of this chapter. Grazing cattle: Administer 1 cartridge (c) Special considerations. See § 500.25 to each animal at the start of the graz- of this chapter. ing season. (d) Conditions of use in horses and (2) Indications for use. For control of ponies—(1) Amount. 0.4 milligram the adult stage of the following gastro- moxidectin per kilogram (2.2 pounds) of intestinal nematode infections in body weight. weaned calves and yearling cattle (2) Indications for use. For the treat- weighing a minimum of 200 pounds: ment and control of large strongyles: Ostertagia spp., Trichostrongylus axei, Strongylus vulgaris (adults and L4/L5 ar- Cooperia spp., and Oesophagostomum terial stages), S. edentatus (adult and radiatum. tissue stages), Triodontophorus (3) Limitations. Administer orally brevicauda (adults), and T. serratus with the dosing gun to all cattle that (adults); small strongyles (adults): will be grazing the same pasture. Effec- Cyathostomum spp., including C. tiveness of the drug product is depend- catinatum and C. pateratum; ent upon continuous control of the gas- Cylicocyclus. spp., including C. insigne, trointestinal parasites for approxi- C. leptostomum, C. nassatus, and C. mately 90 days following administra- radiatus; Cyliocostephanus spp., includ- tion. Therefore, treated cattle should ing C. calicatus, C. goldi, C. not be moved to pastures grazed in the longibursatus, and C. minutus; same grazing season/calendar year by Coronocyclus spp., including C. untreated cattle. Do not administer to coronatus, C. labiatus, and C. labratus; cattle within 102 days of slaughter. Gyalocephalus capitatus; and Consult your veterinarian before ad- Petrovinema poculatus; small ministering to severely debilitated ani- strongyles: undifferentiated lumenal mals and for assistance in the diag- larvae; encysted cyathostomes (late L3 nosis, treatment, and control of para- and L4 mucosal cyathostome larvae); sitism. ascarids: (adults and L4 larval stages); pinworms: Oxyuris [56 FR 13396, Apr. 2, 1991] equi (adults and L4 larval stages); hairworms: Trichostrongylus axei § 520.1451 Moxidectin tablets. (adults); large-mouth stomach worms: (a) Specifications. Each tablet con- Habronema muscae (adults); and horse tains 30, 68, or 136 micrograms of stomach bots: Gasterophilus intestinalis moxidectin. (2nd and 3rd instars) and G. nasalis (3rd

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