StacksVerified U.S. regulatory reference

21 CFR §524.2620

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications.
    1. (1)Each gram of liquid or aerosol contains 0.12 milligram of crystalline trypsin, 87.0 milligrams of Peru balsam, and 788.0 milligrams of castor oil.
    2. (2)Each gram of liquid or aerosol contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams of castor oil.
  2. (b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) in this section:
    1. (1)No. 069043 for use of product described in paragraph (a)(1).
    2. (2)No. 017135 for use of product described in paragraph (a)(2).
  3. (c)Conditions of use—(1) Amount. Apply directly to the wound site.
    1. (2)Indications for use. As an aid in the treatment of external wounds and assists healing by facilitating the removal of necrotic tissue, exudate, and organic debris.