21 CFR Ch. I (4–1–11 Edition) § 524.86

§ 524.86 21 CFR Ch. I (4–1–11 Edition)

SOURCE: 40 FR 13873, Mar. 27, 1975, unless § 524.155 Bacitracin zinc-polymyxin B otherwise noted. sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate § 524.86 Amitraz liquid. ophthalmic ointment. (a) Specifications. Amitraz liquid con- (a) Sponsor. To firms identified in tains 19.9 percent amitraz in an organic § 510.600(c) of this chapter as follows: solvent. (1) To 000061; each gram of ointment (b) Sponsor. See No. 000009 in contains 400 units of bacitracin zinc, § 510.600(c) of this chapter. 10,000 units of polymyxin B sulfate, 5 (c) Conditions of use—(1) Indications milligrams of neomycin sulfate (equiv- for use. For dogs for the treatment of alent to 3.5 milligrams of neomycin generalized demodicosis (Demodex base), and 10 milligrams of hydro- canis). cortisone. (2) Amount. One 10.6 milliliter bottle (2) To 025463; each gram of ointment per 2 gallons of warm water (250 parts contains 400 units of bacitracin zinc, per million) for each treatment, for a 10,000 units of polymyxin B sulfate, 5 total of 3 to 6 treatments, 14 days milligrams of neomycin sulfate (equiv- apart. alent to 3.5 milligrams of neomycin (3) Limitations. Continue treatment base), and 10 milligrams of hydro- until no viable mites are found in skin cortisone acetate. scrapings at 2 successive treatments, (b) Conditions of use. Dogs and cats— or until 6 treatments have been ap- (1) Amount. Apply a thin film over the plied. Do not use for treatment of lo- cornea three or four times daily. calized demodicosis or scabies. Federal (2) Indications for use. For treating law restricts this drug to use by or on acute or chronic conjunctivitis caused the order of a licensed veterinarian. by susceptible organisms. [47 FR 18589, Apr. 30, 1982] (3) Limitations. All topical ophthalmic preparations containing corticosteroids § 524.154 Bacitracin or bacitracin zinc- with or without an antimicrobial agent neomycin sulfate-polymyxin B sul- are contraindicated in the initial treat- fate ophthalmic ointment. ment of corneal ulcers. They should (a) Sponsor. To firms identified in not be used until the infection is under § 510.600(c) of this chapter as follows: control and corneal regeneration is (1) To 000009; each gram contains 500 well underway. Federal law restricts units of bacitracin, 3.5 milligrams of this drug to use by or on the order of a neomycin, and 10,000 units of poly- licensed veterinarian. myxin B. [57 FR 37333, Aug. 18, 1992, as amended at 61 (2) To 000061 and 025463; each gram FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, contains 400 units of bacitracin zinc, 3.5 1997] milligrams of neomycin, and 10,000 units of polymyxin B sulfate. § 524.390 Chloramphenicol ophthalmic (b) Conditions of use. Dogs and Cats— and topical dosage forms. (1) Amount. Apply a thin film over the cornea 3 or 4 times daily. § 524.390a Chloramphenicol oph- (2) Indications for use. Treatment of thalmic ointment. superficial bacterial infections of the (a) Specifications. Each gram contains eyelid and conjunctiva of dogs and cats 10 milligrams chloramphenicol in a when due to susceptible organisms. petrolatum base. (3) Limitations. Laboratory tests (b) Sponsor. See Nos. 000856 and 025463 should be conducted including in vitro in § 510.600(c) of this chapter for use as culturing and susceptibility tests on in paragraph (c)(1)(i) of this section. samples collected prior to treatment. See No. 017030 for use as in paragraph Federal law restricts this drug to use (c)(1)(ii) of this section. by or on the order of a licensed veteri- (c) Conditions of use. Dogs and cats— narian. (1) Amount. Apply as follows: [57 FR 37333, Aug. 18, 1992, as amended at 61 (i) Every 3 hours around the clock for FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 48 hours after which night instillations 1997] may be omitted.

326

VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00336 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 Food and Drug Administration, HHS § 524.402

(ii) Four to six times daily to af- products must not be used in meat-, fected eye for the first 72 hours depend- egg-, or milk-producing animals. The ing upon the severity of the condition. length of time that residues persist in A small amount of ointment should be milk or tissues has not been deter- placed in the lower conjunctival sac. mined. Federal law restricts this drug (2) Indications for use. Treatment of to use by or on the order of a licensed bacterial conjunctivitis caused by veterinarian. pathogens susceptible to chloramphenicol. [57 FR 37333, Aug. 18, 1992] (3) Limitations. Continue treatment § 524.390d Chloramphenicol-prednis- for 48 hours (2 days) after eye appears olone ophthalmic ointment. normal. Therapy for cats should not exceed 7 days. Prolonged use in cats (a) Specifications. Each gram contains may produce blood dyscrasias. If im- 10 milligrams of chloramphenicol and provement is not noted in a few days a 2.5 milligrams of prednisolone acetate. change of therapy should be consid- (b) Sponsor. See No. 017030 in ered. When infection may be cause of § 510.600(c) of this chapter. disease, especially in purulent or ca- (c) Conditions of use. Dogs and cats— tarrhal conjunctivitis, attempts should (1) Amount. Apply 4 to 6 times daily to be made to determine through suscep- the affected eye for the first 72 hours tibility testing, which antibiotics will depending upon the severity of the con- be effective prior to applying oph- dition. Continue treatment for 48 hours thalmic preparations. This chlor- after the eye appears normal. amphenicol product must not be used (2) Indications for use. Treatment of in animals producing meat, eggs, or bacterial conjunctivitis and ocular in- milk. The length of time that residues flammation caused by organisms sus- persist in milk or tissues has not been ceptible to chloramphenicol. determined. Federal law restricts this (3) Limitations. Therapy for cats drug to use by or on the order of a li- should not exceed 7 days, prolonged use censed veterinarian. in cats may produce blood dyscrasia. As with other antibiotics, prolonged [57 FR 37333, Aug. 18, 1992] use may result in overgrowth of nonsusceptible organisms. If superinfec- § 524.390b Chloramphenicol ophthalmic solution. tion occurs or if clinical improvement is not noted within a reasonable period, (a) Specifications. Each milliliter con- discontinue use and institute appro- tains 5 milligrams of chloramphenicol. priate therapy. All topical ophthalmic (b) Sponsor. See No. 017030 in preparations containing § 510.600(c) of this chapter. corticosteroids, with or without an (c) Conditions of use. Dogs and Cats— antimicrobial agent, are contra- (1) Amount. Apply one or two drops, 4 to indicated in the initial treatment of 6 times a day for the first 72 hours, de- corneal ulcers. They should not be used pending upon the severity of the condi- until the infection is under control and tion. Intervals between applications corneal regeneration is well underway. may be increased after the first 2 days. Chloramphenicol products must not be (2) Indications for use. Treatment of used in meat-, egg-, or milk-producing bacterial conjunctivitis caused by or- animals. The length of time that resi- ganisms susceptible to chloramphen- dues persist in milk or tissues has not icol. Therapy should be continued for been determined. Federal law restricts 48 hours after the eye appears normal. this drug to use by or on the order of a (3) Therapy for cats Limitations. licensed veterinarian. should not exceed 7 days. As with other antibiotics, prolonged use may result [57 FR 37334, Aug. 18, 1992] in overgrowth of nonsusceptible organisms. If superinfection occurs, or if § 524.402 Chlorhexidine. clinical improvement is not noted (a) Specifications. Each gram of oint- within a reasonable period, discontinue ment contains 10 milligrams use, and institute appropriate therapy. chlorhexidine acetate. Prolonged use in cats may produce (b) Sponsors. See Nos. 000856 and blood dyscrasias. Chloramphenicol 058829 in § 510.600(c) of this chapter.

327

VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00337 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150