---
kind: "section"
citation: "21 C.F.R. § 201.24"
title: "21"
number: "201.24"
heading: "Labeling for systemic antibacterial drug products."
url: "https://uscodex.org/cfr/21/201.24"
---

# §201.24. Labeling for systemic antibacterial drug products.


The labeling of all systemic drug products intended for human use indicated to treat a bacterial infection, except a mycobacterial infection, must bear the following statements:

- (a) At the beginning of the label, under the product name, the labeling must state:
- (b) In the “Indications and Usage” section, the labeling must state:
- (c) In the “Precautions” section, under the “General” subsection, the labeling must state:
- (d) In the “Precautions” section, under the “Information for Patients” subsection, the labeling must state:

## Notes

### Amendments

[68 FR 6081, Feb. 6, 2003]

### Authority

Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

### Source

Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

### Amendments

[68 FR 6081, Feb. 6, 2003]