(a)
(1) Specifications.
The drug is a liquid for direct application or an aerosol preparation formulated so that each gram delivered to the wound site contains 0.12 milligram of crystalline trypsin, 87.0 milligrams of Peru balsam, and 788.0 milligrams of castor oil.
(2) Sponsor.
See No. 051079 in § 510.600(c) of this chapter.
(b)
(1) Specifications.
The drug is a liquid for direct application or an aerosol preparation formulated so that each gram delivered to the wound site contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams of castor oil.
(2) Sponsor.
See No. 017135 in § 510.600(c) of this chapter.
(c) Conditions of use.
The drug is used as an aid in the treatment of external wounds and assists healing by facilitating the removal of necrotic tissue, exudate and organic debris.
Code of Federal Regulations
[40 FR 13873, Mar. 27, 1975, as amended at 41 FR 56307, Dec. 28, 1976; 50 FR 9800, Mar. 12, 1985; 54 FR 25565, June 16, 1989; 56 FR 37474, Aug. 7, 1991; 66 FR 46369, Sept. 5, 2001; 72 FR 36595, July 5, 2007]