Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 524  /  Sec. 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution.

(a) Specifications. Each milliliter of ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, with or without hydroxypropyl methylcellulose.

(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

(c) Conditions of use--(1) Amount--(i) Preparation containing hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours.

(1) Amount--(i) Preparation containing hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours.

(i) Preparation containing hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours.

(ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours.

(2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, 2013] Sec. 524.981 [Reserved] Sec. 524.981a Fluocinolone cream.

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide.

(b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount--A small amount is applied to the affected area two or three times daily.

(1) Amount--A small amount is applied to the affected area two or three times daily.

(2) Indications for use. For the relief of pruritis and inflammation associated with certain superficial acute and chronic dermatoses. It is used in the treatment of allergic and acute moist dermatitis and for the relief of superficial inflammation caused by chemical burns and physical abrasions.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, 2014] Sec. 524.981b Fluocinolone solution.

(a) Specifications. The drug contains 0.01 percent fluocinolone acetonide.

(b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount--A small amount of solution is applied to the affected area two or three times daily.

(1) Amount--A small amount of solution is applied to the affected area two or three times daily.

(2) Indications for use--(i) Dogs. For the relief of pruritis and inflammation associated with otitis externa and certain superficial acute and chronic dermatoses.

(i) Dogs. For the relief of pruritis and inflammation associated with otitis externa and certain superficial acute and chronic dermatoses.

(ii) Cats. For the relief of pruritis and inflammation associated with acute otitis externa and certain superficial acute and chronic dermatoses.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014] Sec. 524.981c Fluocinolone and neomycin cream.

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide and 0.5 percent neomycin sulfate (0.35 percent neomycin base).

(b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount--A small amount is applied to the affected area two or three times daily.

(1) Amount--A small amount is applied to the affected area two or three times daily.

(2) Indications for use--(i) Dogs. For the relief of pruritis and inflammation associated with superficial acute and chronic dermatoses. It is used in the treatment of allergic and acute moist dermatitis and nonspecific dermatoses.

(i) Dogs. For the relief of pruritis and inflammation associated with superficial acute and chronic dermatoses. It is used in the treatment of allergic and acute moist dermatitis and nonspecific dermatoses.

(ii) Dogs and cats. Used in the treatment of wound infections.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014] Sec. 524.981d Fluocinolone and dimethyl sulfoxide solution.

(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 20 percent dimethyl sulfoxide.

(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount--Instill 1 to 2 milliliters into each anal sac following expression of anal sac contents.

(1) Amount--Instill 1 to 2 milliliters into each anal sac following expression of anal sac contents.

(2) Indications for use. For the relief of impaction commonly present in apparently normal anal sacs, for the reversal of inflammatory changes associated with abnormal anal sacs, and to counteract the offensive odor of anal sac secretions.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 10969, Feb. 27, 2014] Sec. 524.981e Fluocinolone and dimethyl sulfoxide otic solution.

(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.

(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount--Instill 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters.

(1) Amount--Instill 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters.

(2) Indications for use. For the relief of pruritis and inflammation associated with acute and chronic otitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 10969, Feb. 27, 2014]