Section 522.2450 - Tigilanol(a)Specifications. Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate.(b)Sponsor. See No. 086132 in § 510.600(c) of this chapter.(c)Conditions of use in dogs - (1)Amount. Administer as an intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor volume.(2)Indications for use. For the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock in dogs.(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.86 FR 17064, Apr. 1, 2021