CFR

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522.778—Doxycycline hyclate.

(a) Specifications. Doxycycline hyclate solution contains 8.5 percent doxycycline activity. A syringe of N -methyl-2-pyrrolidone and poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5 milliliter of solution.

(b) Sponsor. See 000009 in § 510.600(c) of this chapter.

(d) Conditions of use— (1) Dogs— Apply subgingivally to periodontal pocket(s) of affected teeth.

(ii) Indications for use. For treatment and control of periodontal disease.

(iii) Limitations. Do not use in dogs less than 1-year old. Use of tetracyclines during tooth development has been associated with permanent discoloration of teeth. Do not use in pregnant bitches. Use in breeding dogs has not been evaluated. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[63 FR 8349, Feb. 19, 1998, as amended at 65 FR 45878, July 26, 2000]

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