21 C.F.R. § 524.660b   Dimethyl sulfoxide gel.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 524.660b   Dimethyl sulfoxide gel.

(a) Specifications. Dimethyl sulfoxide gel, veterinary contains 90 percent dimethyl sulfoxide in an aqueous gel.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Indications for use. For use on horses and dogs as a topical application to reduce acute swelling due to trauma.

(2) Amount—(i) Horses. Administer 2 or 3 times daily in an amount not to exceed 100 grams per day. Total duration of therapy should not exceed 30 days.

(ii) Dogs. Administer 3 or 4 times daily in an amount not to exceed 20 grams per day. Total duration of therapy should not exceed 14 days.

(3) Limitations. Do not use in horses and dogs intended for breeding purposes or in horses slaughtered for food. Restricted to topical use on horses and dogs only. Due to rapid penetrating ability of dimethyl sulfoxide, rubber gloves should be worn when applying the drug. No other medications should be present on the skin prior to application of the drug. 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 48 FR 56205, Dec. 20, 1983; 61 FR 5507, Feb. 13, 1996]

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