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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter EPart 524 → §524.1662a

Title 21: Food and Drugs

§524.1662a   Oxytetracycline and hydrocortisone spray.

(a) Specifications. Each 3-ounce unit of oxytetracycline hydrochloride and hydrocortisone spray contains 300 milligrams of oxytetracycline hydrochloride and 100 milligrams of hydrocortisone with an inert freon propellant such that a 1-second spray treatment will deliver approximately 2.5 milligrams of oxytetracycline hydrochloride and 0.8 milligram of hydrocortisone.

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

(c) Conditions of use in dogs and cats—(1) Amount. A small quantity should be sprayed on the affected surface by holding the container about 6 inches from the area to be treated and pressing the nozzle for 1 or 2 seconds. Only sufficient spray to coat the skin thinly is necessary. The application of small amounts at frequent intervals will give best results. Before treating animals with long or matted hair, it may be necessary to clip the affected area or spread the hairs to allow the medication to contact the skin surface. Relief may be noted following the first or second treatment; however, treatment should not be discontinued too soon after the initial favorable response has been obtained.

(2) Indications for use. For the relief of discomfort and continued treatment of many allergic, infectious, and traumatic skin conditions; for the prevention of bacterial infections in superficial wounds, cuts, and abrasions, treatment of allergic dermatoses, including urticaria, eczemas, insect bites, and cutaneous drug reactions, infections associated with minor burns and wounds, and nonspecific pruritus.

(3) Limitations. Keep away from eyes or other mucous membranes; avoid inhaling; use with adequate ventilation; in case of deep or puncture wounds or serious burns, consult a veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014]

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