StacksVerified U.S. regulatory reference

21 CFR §524.1446

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.
  2. (b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
  3. (c)Conditions of use—(1) Amount. One tube administered topically into each external ear canal.
    1. (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.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.