Labeling.
21 C.F.R. § 640.84
in effectEffective: 2024-07-01In addition to the labeling requirements of §§ 610.60, 610.61, and 610.62 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026