21 C.F.R. § 524.660a   Dimethyl sulfoxide solution.


Title 21 - Food and Drugs


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

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§ 524.660a   Dimethyl sulfoxide solution.

(a) Specifications. Dimethyl sulfoxide contains 90 percent of dimethyl sulfoxide and 10 percent of water.

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

(c) Conditions of use. (1) It is used or intended for use as a topical application to reduce acute swelling due to trauma:

(i) In horses administered 2 or 3 times daily in an amount not to exceed 100 milliliters per day. Total duration of therapy should not exceed 30 days.

(ii) In dogs administered 3 or 4 times daily in an amount not to exceed 20 milliliters per day. Total duration of therapy should not exceed 14 days.

(2) Not for use in horses and dogs intended for breeding purposes nor in horses slaughtered for food. Other topical medications should only be used when the dimethyl sulfoxide treated area is thoroughly dry. Do not administer by any other route.

(3) For use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]

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