Specifications. Each gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.
Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.
No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.
No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-g bottles.
No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.
No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
Conditions of use in dogs—(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.
From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.
From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.
From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.
Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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