---
kind: "section"
citation: "21 C.F.R. § 520.1189"
title: "21"
number: "520.1189"
heading: "Itraconazole."
url: "https://uscodex.org/cfr/21/520.1189"
---

# §520.1189. Itraconazole.

- (a) **Specifications.** Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole.
- (b) **Sponsor.** See No. 051311 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles.
  - (2) **Indications for use.** For the treatment of dermatophytosis caused by Microsporum canis in cats.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]