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21 CFR § 524.2098 - Selamectin.

---
identifier: "/us/cfr/t21/s524.2098"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.2098 - Selamectin."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.2098"
section_name: "Selamectin."
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: "524"
part_name: "OPHTHALMIC AND TOPICAL 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 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---

# 524.2098 Selamectin.

(a) *Specifications.* Each milliliter contains 60 or 120 milligrams (mg) of selamectin.

(b) *Sponsors.* See Nos. 051072, 051311, 054771, 055529, 061133, and 086117 of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer topically 2.7 mg of selamectin per pound (6 mg per kilogram) of body weight.

(2) *Indications for use.* Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (*Ctenocephalides felis*), prevention of heartworm disease caused by *Dirofilaria immitis,* and treatment and control of ear mite (*Otodectes cynotis*) infestations in dogs and cats. Treatment and control of sarcoptic mange (*Sarcoptes scabiei*) and control of tick (*Dermacentor variabilis*) infestations in dogs. Treatment and control of intestinal hookworm (*Ancylostoma tubaeforme*) and roundworm (*Toxocara cati*) infections in cats. For dogs 6 weeks of age and older, and cats 8 weeks of age and older.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, Feb. 27, 2014; 86 FR 17064, Apr. 1, 2021; 87 FR 58963, Sept. 29, 2022; 89 FR 14410, Feb. 27, 2024; 89 FR 42360, May 15, 2024]