This specification covers the requirements for labels used for small-volume parenteral drug containers, in particular, the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers. The label shall contain the proprietary name of the drug (optional), established or generic name of the drug (required), amount of drug per unit, and, for liquids, the total volume of the contents-all of which shall be printed in conformity with the type size (as large as possible), orientation (parallel to the long axis of the container), and legibility (provide contrast between the type used for proprietary and established names of the drug and amount of drug per unit, and avoid the use of pastel shades for label background) requirements. Legibility test shall be performed to assess the conformance of the label with the requirements specified.

1.1 This specification covers the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers having a volume of 100 mL or less.

1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.