Food and Drug Administration, HHS § 524.155

524.1484f Neomycin, prednisolone, and tetra- (3) Limitations. Federal law restricts caine otic suspension. this drug to use by or on the order of a 524.1484g Neomycin, thiabendazole, and licensed veterinarian. dexamethasone solution. 524.1484h Neomycin, penicillin, polymyxin [47 FR 18589, Apr. 30, 1982, as amended at 79 B, and hydrocortisone suspension. FR 10967, Feb. 27, 2014] 524.1484i Neomycin and hydrocortisone oint- ment. § 524.154 Bacitracin, neomycin, and 524.1484j Neomycin and prednisolone oph- polymyxin B ophthalmic ointment. thalmic ointment. 524.1484k Prednisolone and neomycin sus- (a) Specifications. Each gram of oint- pension. ment contains: 524.1580 Nitrofurazone topical dosage forms. (1) 500 units of bacitracin, 3.5 milli- 524.1580a Nitrofurazone ointment. grams of neomycin, and 10,000 units of 524.1580b Nitrofurazone soluble powder. polymyxin B sulfate; or 524.1580c Nitrofurazone and butacaine oint- (2) 400 units of bacitracin zinc, 3.5 ment. 524.1600 ophthalmic and topical milligrams of neomycin, and 10,000 dosage forms. units of polymyxin B sulfate. 524.1600a Nystatin, neomycin, thiostrepton, (b) Sponsors. See sponsor numbers in and triamcinolone ointment. § 510.600(c) of this chapter as follows: 524.1600b Nystatin, neomycin, thiostrepton, (1) No. 054771 for use of product de- and triamcinolone ophthalmic ointment scribed in paragraph (a)(1) as in para- 524.1610 Orbifloxacin, mometasone furoate monohydrate, and suspen- graph (c) of this section. sion. (2) Nos. 000061 and 043264 for use of 524.1662 Oxytetracycline ophthalmic and product described in paragraph (a)(2) as topical dosage forms. in paragraph (c) of this section. 524.1662a Oxytetracycline and hydro- (c) Conditions of use in dogs and cats.— cortisone spray. (1) Amount. Apply a thin film over the 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. cornea 3 or 4 times daily. 524.1742 N-(Mercaptomethyl) phthalimide S- (2) Indications for use. Treatment of (O,O-dimethyl phosphorodithioate) emul- superficial bacterial infections of the sifiable liquid. eyelid and conjunctiva of dogs and cats 524.1982 Proparacaine ophthalmic solution. when due to susceptible organisms. 524.2098 Selamectin. (3) Limitations. Federal law restricts 524.2101 disulfide suspension. this drug to use by or on the order of a 524.2350 cream. 524.2482 Triamcinolone spray. licensed veterinarian. 524.2483 Triamcinolone cream. [57 FR 37333, Aug. 18, 1992, as amended at 61 524.2620 Liquid crystalline trypsin, Peru FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, balsam, castor oil. 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, AUTHORITY: 21 U.S.C. 360b. Feb. 27, 2014] SOURCE: 40 FR 13873, Mar. 27, 1975, unless § 524.155 Bacitracin, neomycin, poly- otherwise noted. myxin B, and hydrocortisone oph- thalmic ointment. § 524.86 Amitraz. (a) Specifications. Each gram of oint- (a) Specifications. Amitraz liquid con- tains 19.9 percent amitraz in an organic ment contains 400 units of bacitracin solvent. zinc, 5 milligrams (mg) of neomycin (b) Sponsor. See No. 054771 in sulfate (equivalent to 3.5 mg of neomy- § 510.600(c) of this chapter. cin sulfate), 10,000 units of polymyxin B (c) Conditions of use—(1) Indications sulfate, and10 mg of hydrocortisone. for use. For dogs for the treatment of (b) Sponsors. See Nos. 000061 and generalized demodicosis (Demodex 043264 in § 510.600(c) of this chapter. canis). (c) Conditions of use in dogs and cats.— (2) Amount. One 10.6 milliliter bottle (1) Amount. Apply a thin film over the per 2 gallons of warm water (250 parts cornea three or four times daily. per million) for each treatment, for a (2) Indications for use. For treating total of 3 to 6 treatments, 14 days acute or chronic conjunctivitis caused apart. by susceptible organisms.

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(3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [57 FR 37333, Aug. 18, 1992, as amended at 61 [40 FR 48128, July 18, 1980, as amended at 79 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, FR 10967, Feb. 27, 2014] 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] § 524.463 Copper naphthenate. (a) Amount. The drug is a 37.5 percent § 524.390 Chloramphenicol ophthalmic ointment. solution of copper naphthenate. (b) Sponsors. See Nos. 017135, 054771, (a) Specifications. Each gram contains and 058829 in § 510.600(c) of this chapter. 10 milligrams chloramphenicol. (c) Conditions of use in horses—(1) (b) Sponsors. See Nos. 043264 and Amount. Apply daily to affected hooves 054771 in § 510.600(c) of this chapter. until fully healed. (c) Conditions of use in dogs and cats— (2) Indications for use. As an aid in (1) Amount. Apply every 3 hours around treating horses and ponies for thrush the clock for 48 hours, after which caused by organisms susceptible to night instillations may be omitted. copper naphthenate. (2) Indications for use. For treatment (3) Limitations. Use on horses and of bacterial conjunctivitis caused by ponies only. Avoid contact around pathogens susceptible to chloramphen- eyes. Do not contaminate feed. Do not icol. use in horses intended for human con- (3) Limitations. Federal law restricts sumption. this drug to use by or on the order of a licensed veterinarian. Federal law pro- [47 FR 4250, Jan. 29, 1982, as amended at 68 hibits the use of this drug in food-pro- FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, ducing animals. 2006; 79 FR 10967, Feb. 27, 2014] [77 FR 4897, Feb. 1, 2012, as amended at 77 FR § 524.575 Cyclosporine ophthalmic 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] ointment. (a) Specifications. Each gram of oint- § 524.402 Chlorhexidine. ment contains 2 milligrams of (a) Specifications. Each gram of oint- cyclosporine. ment contains 10 milligrams (b) Sponsor. See No. 000061 in chlorhexidine acetate. § 510.600(c) of this chapter. (b) Sponsors. See Nos. 054771 and (c) Conditions of use—(1) Amount. 058829 in § 510.600(c) of this chapter. Apply a 1⁄4-inch strip of ointment di- (c) Conditions of use in dogs, cats, and rectly on the cornea or into the con- horses—(1) Indications for use. For use junctival sac of the affected eye(s) as a topical antiseptic ointment for every 12 hours. surface wounds. (2) Indications for use. For manage- (2) Limitations. Do not use in horses ment of chronic keratoconjunctivitis intended for human consumption. sicca (KCS) and chronic superficial [72 FR 265, Jan. 4, 2007, as amended at 79 FR keratitis (CSK) in dogs. 10967, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.450 . licensed veterinarian. (a) Specifications. Each gram of cream [60 FR 48651, Sept. 20, 1995, as amended at 62 contains 10 milligrams of clotrimazole. FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, (b) Sponsors. See No. 000859 in 2014] § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. § 524.590 . Apply 1⁄4-inch ribbon of cream per (a) Specifications. Each gram of cream square inch of lesion once daily for 2 to contains 10 milligrams diclofenac so- 4 weeks. dium. (2) Indications of use. For the treat- (b) Sponsor. See No. 000010 in ment of fungal infections of dogs and § 510.600(c) of this chapter. cats caused by Microsporum canis and (c) Conditions of use in horses—(1) Trichophyton mentagrophytes. Amount. Apply a 5-inch (5″) ribbon of

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