(a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in dogs and cats for the topical treatment of infections of the conjunctiva caused by susceptible bacteria.
(1) The drug is used in dogs and cats for the topical treatment of infections of the conjunctiva caused by susceptible bacteria.
(2) Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [41 FR 14189, Apr. 2, 1976, as amended at 52 FR 7832, Mar. 13, 1987] Sec. 524.1044b Gentamicin and betamethasone otic solution.
(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base and betamethasone valerate equivalent to 1 mg betamethasone alcohol.
(b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amounts and indications for use--(i) For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs, instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.
(1) Amounts and indications for use--(i) For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs, instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.
(i) For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs, instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.
(ii) For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin in dogs and cats, apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 13542, Mar. 16, 2006] Sec. 524.1044c Gentamicin ophthalmic ointment.
(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.
(b) Sponsors. See Nos. 000061 and 043264 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Apply approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.
(1) Amount. Apply approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.
(2) Indications for use. For treatment of conjunctivitis caused by susceptible bacteria.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 47363, Aug. 5, 2004, as amended at 77 FR 64717, Oct. 23, 2012] Sec. 524.1044d Gentamicin and betamethasone ointment.
(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount--(i) Otitis externa. Instill 3 to 8 drops into the ear canal twice daily for 7 days.
(1) Amount--(i) Otitis externa. Instill 3 to 8 drops into the ear canal twice daily for 7 days.
(i) Otitis externa. Instill 3 to 8 drops into the ear canal twice daily for 7 days.
(ii) Infected superficial lesions. Apply to cover the treatment area twice daily for 7 to 14 days.
(2) Indications for use. For the treatment of acute and chronic otitis externa and infected superficial lesions caused by bacteria sensitive to gentamicin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014] Sec. 524.1044e Gentamicin spray.
(a) Specification. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Amount. Hold the sprayer upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pump once. Treat once daily for up to 3 days.
(1) Amount. Hold the sprayer upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pump once. Treat once daily for up to 3 days.
(2) Indications for use. For the treatment of pinkeye in cattle (infectious bovine keratoconjunctivitis) caused by Moraxella bovis.
(3) Limitations. Conditions other than bacterial infections of the bovine eye and infectious keratoconjunctivitis caused by Moraxella bovis may produce similar signs. If conditions persists or increases, discontinue use and consult a veterinarian. [48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014] Sec. 524.1044f Gentamicin and betamethasone spray.
(a) Specifications. Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram (mg) gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone.
(b) Sponsors. See Nos. 000061, 054925, 058005, 058829, and 065531 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer two spray actuations two to four times daily for 7 days.
(1) Amount. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer two spray actuations two to four times daily for 7 days.
(2) Indications for use. For the treatment of infected superficial lesions caused by bacteria susceptible to gentamicin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 13542, Mar. 16, 2006, as amended at 72 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012] Sec. 524.1044g Gentamicin, betamethasone, and clotrimazole ointment.
(a) 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.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for uses as in paragraph (c) of this section.
(1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.
(2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-g bottles.
(3) No. 000859 for use of 10-, 20-, 40-, or 215-g bottles.
(4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
(c) Conditions of use in dogs--(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.
(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.
(i) 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.
(ii) 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.
(ii) 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.
(2) 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.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014] Sec. 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension.
(a) Specifications. Each gram contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once or twice daily for 7 days.
(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once or twice daily for 7 days.
(2) Indications for use. For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; 79 FR 10969, Feb. 27, 2014] Sec. 524.1044i Gentamicin and betamethasone ophthalmic solution.
(a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Instill one or two drops of solution in the conjunctival sac three or four times a day.
(1) Amount. Instill one or two drops of solution in the conjunctival sac three or four times a day.
(2) Indications for use. For treatment of external eye infections and inflammation.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]