- (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]