21 CFR § 524.2099 - Selamectin and sarolaner.

---
identifier: "/us/cfr/t21/s524.2099"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.2099 - Selamectin and sarolaner."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.2099"
section_name: "Selamectin and sarolaner."
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"
---


# 524.2099 Selamectin and sarolaner.

(a) *Specifications.* Each milliliter (mL) of solution contains 60 milligrams (mg) selamectin and 10 mg sarolaner. The drug is provided in single dose tubes containing 0.25, 0.5, or 1 mL of solution.

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

(c) *Conditions of use in cats*—(1) *Amount.* Administer 2.7 mg selamectin per pound (/lb) (6 mg per kilogram (/kg)) of body weight and 0.45 mg/lb sarolaner (1 mg/kg) by emptying the contents of the tube on the back of the animal at the base of the neck in front of the shoulder blades.

(2) *Indications for use.* For the prevention of heartworm disease caused by *Dirofilaria immitis,* the treatment and control of roundworm (*Toxocara cati*) and intestinal hookworm (*Ancylostoma tubaeforme*) infections, and the treatment and control of ear mite (*Otodectes cynotis*) infestations. Kills adult fleas (*Ctenocephalides felis*) and is indicated for the treatment and prevention of flea infestations, the prevention of *Dipylidium caninum* (tapeworm) infections as a direct result of killing *Ctenocephalides felis* vector fleas on the treated cat, and the treatment and control of tick infestations with *Amblyomma americanum* (lone star tick), *Amblyomma maculatum* (Gulf Coast tick), *Dermacentor variabilis* (American dog tick), and *Ixodes scapularis* (black-legged tick) for 1 month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.

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

[84 FR 12494, Apr. 2, 2019, as amended at 89 FR 14410, Feb. 27, 2024; 90 FR 6801, Jan. 21, 2025]