[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR524.1446] [Page 305] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents Sec. 524.1446 Milbemycin oxime solution. (a) Specifications. Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. One tube administered topically into each external ear canal. (2) Indications for use. For the treatment of ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [65 FR 13905, Mar. 15, 2000, as amended at 66 FR 13849, Mar. 8, 2001]