---
kind: "section"
citation: "21 C.F.R. § 640.84"
title: "21"
number: "640.84"
heading: "Labeling."
url: "https://uscodex.org/cfr/21/640.84"
---

# §640.84. Labeling.


In addition to the labeling requirements of §§ [610.60](/cfr/21/610.60.md), [610.61](/cfr/21/610.61.md), and [610.62](/cfr/21/610.62.md) of this chapter, the container and package labels shall contain the following information:

- (a) The osmotic equivalent in terms of plasma, and the sodium concentration in terms of a value or a range in milliequivalents per liter;
- (b) **The cautionary statement placed in a prominent position on the label, “Do Not Use if Turbid.** Do Not Begin Administration More Than 4 Hours After the Container Has Been Entered.”;
- (c) The need for additional fluids when 20 percent or 25 percent albumin is administered to a patient with marked dehydration;
- (d) **The protein concentration, expressed as a 4 percent, 5 percent, 20 percent, or 25 percent solution.**

## Notes

### Amendments

[42 FR 27582, May 31, 1977, as amended at 49 FR 2244, Jan. 19, 1984; 64 FR 26286, May 14, 1999]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[42 FR 27582, May 31, 1977, as amended at 49 FR 2244, Jan. 19, 1984; 64 FR 26286, May 14, 1999]