CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.2620]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.2620 Liquid crystalline trypsin, Peru balsam, castor oil.

(a) Specifications. (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) 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.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) in this section:

(1) No. 069043 for use of product described in paragraph (a)(1).

(2) No. 017135 for use of product described in paragraph (a)(2).

(c) Conditions of use - (1) Amount. Apply directly to the wound site.

(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.

[79 FR 10973, Feb. 27, 2014, as amended at 88 FR 14901, Mar. 10, 2023]