21 CFR § 529.539 - Dexmedetomidine.

§ 529.539 Dexmedetomidine.

(a) Specifications. Each milliliter of gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride).

(b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer onto the oral mucosa between the dog's cheek and gum at a dose of 125 micrograms per square meter.

(2) Indications for use. For the treatment of noise aversion in dogs.

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

[81 FR 17608, Mar. 30, 2016]