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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1452]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1452 Moxidectin gel.

(a) Specifications. Each milliliter of gel contains 20 milligrams (2 percent) moxidectin.

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

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

(d) Conditions of use in horses and ponies - (1) Amount. 0.4 milligram moxidectin per kilogram (2.2 pounds) of body weight.

(2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): Cyathostomum spp., including C. catinatum and C. pateratum ; Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus , and C. radiatus; Cyliocostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus ; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus ; Gyalocephalus capitatus ; and Petrovinema poculatus ; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses strongyle egg production for 84 days.

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

[62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014]

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