21 CFR § 520.1453 - Moxidectin and praziquantel gel.

---
identifier: "/us/cfr/t21/s520.1453"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1453 - Moxidectin and praziquantel gel."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1453"
section_name: "Moxidectin and praziquantel gel."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1453 Moxidectin and praziquantel gel.

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

(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.* 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.

(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*; *Cylicostephanus* 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); horse stomach bots: *Gasterophilus intestinalis* (2nd and 3rd instars) and *G.* *nasalis* (3rd instars); and tapeworms: *Anoplocephala perfoliata* (adults). One dose also suppresses strongyle egg production for 84 days.

(3) *Limitations.* 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]