FDA Label & Artwork Regulations

Corporate trade dress means the way a company packages, wraps, and labels a drug or biologic product including the use of color schemes, sizes, designs, shapes, and placements of words or graphics on a container label and/or carton labeling

No stylized fonts, use sans serif fonts only.

Do not use logos, bars, stripes, watermark graphics, lines and symbols if possible. They can be distracting.

Avoid or minimize the use of corporate trade dress that could make it difficult for end users to distinguish between different medications or different strengths of the same medication.

Do not superimpose text over images or logos

Do not place logo immediately before or after the proprietary name.

No intervening written, printed, or graphic matter between the proprietary name, established name, and product strength.

Information on the PDP such as Rx-only statement, net quantity statement, manufacturer name and logs should not compete in size and prominence with the essential information.

Place manufacture name and logo on side or back panel.

Manufacturer full address should not be included on the large volume parental container or presented in the prescribing information.

Ensure that the product strength stands out. Include the use of boxing, a prominent typeface of type weight, and color differentiation.

Use a consistent unit of measure across all elements of the labeling
Strength should match the units of measure described in the DOSAGE AND ADMINISTRATION section of the prescribing information

Use the same units of measure when labeling multiple products containing the same active ingredient (e.g., use mg for milligram)
For small volume parenteral products, the product strength should be expressed as total quantity per total volume followed by the concentration per milliliter (mL)
o strength per total volume should be the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per milliliter enclosed by parentheses

For containers holding a volume of less than 1 mL, the strength per fraction of a milliliter should be the only expression of strength. For example: 12.5 mg/0.625 mL
Dry powder products should express the strength in terms of the total amount of drug per vial as follows: XX mg/vial
o Instructions for reconstituting the product and the resultant concentration should be included on the vial, if space permits

The dose or expression of strength should appear in metric units of measure such as mL, mg, and mcg, rather than apothecary or household measurements (e.g., tsp for teaspoon)

The net quantity statement should appear on the PDP but should be separate from and less prominent than the statement of strength

Statement of strength should be presented in whole numbers, and not with a decimal point that is followed by a terminal zero (e.g., 4 mg, not 4.0 mg).

Conversely, decimal numbers smaller than one should 472 always be preceded by a zero (e.g., 0.4 mg, not .4 mg).

Statements or blocks of content should be separated by sufficient white space to avoid crowding or clutter.

Information such as the product strength equivalency statement, “each tablet contains” statement, and manufacturer name and logo is best placed on the side or back panel to maximize the prominence of the important information on PDP.

Text on the container label and carton labeling should be generally oriented in the same direction surrounded by adequate white space.

Choose a font that is easy to read, not lightweight or condensed.

FDA recommends the use of at least a 12-point font whenever label size permits.

Place less important information on a side or back panel of the container label and carton labeling, rather than on the PDP, or placing it, as appropriate, in the prescribing information.

Lines or blocks of text should be separated by sufficient white space to avoid crowding or clutter.

Apart from required information about a product’s manufacturer, distributor or packer, information about business partnerships should not appear on the label or labeling.

Certain abbreviations, acronyms, and symbols are dangerous and should not be used. For example, the abbreviation μg for microgram should not be used because it has been mistaken as mg, meaning milligram. The abbreviation mcg is an appropriate abbreviation for microgram. The abbreviation IU for international unit also should not be used because it has been confused for the intravenous route of administration.

Use color to bring attention to the product name, strength, and important warning (s)
Color contrast between the text and the container label background color should be chosen to afford adequate legibility of the text.

Color should not be the only means to distinguish different container label and carton labeling of multiple products across a company’s entire product line or within a line of related products.

Ensure that the product strength stands out using of boxing, a prominent typeface or type weight, and color differentiation
Avoid look-alike container labels and carton labeling that use the same or similar colors in the labels of multiple products across a company’s entire product line or within a line of related products.

Color differentiation is an effective tool that can
Differentiate products within a manufacturer’s product line.
Differentiate strengths within a manufacturer’s product line.
Highlight certain aspects of the label, such as important warning statements.

Color differentiation is most effective when the color used has no association with a particular feature.
Color coding schemes developed to decrease error may actually increase error when the color is relied upon as a shortcut to proper identification (i.e., not reading the label).

Use 10 Point font, no italics or ornate typefaces.

Use upper and lower-case lettering, not all caps.

Use bold type or a box to call attention to essential information.

Do NOT highlight or underline.

Line length no longer than 40 letters long.

Should be considered a stand-alone document presented in an understandable and legible format, easily understandable to consumers.

Trade Labeling (i.e., labeling on or within the package) – minimum 6-point type.
FDA-approved patient labeling that is not for distribution to patients – minimum 6-point type.
FDA-approved patient labeling (except a Medication Guide) that is for distribution to patients minimum 6-point type.

Medication Guide that is for distribution to patients – minimum 10-point type.

Other Labeling (e.g., labeling accompanying promotional materials) – minimum 8-point type.

FDA-approved patient labeling that is not for distribution to patients – minimum 8-point type.

Any FDA-approved patient labeling (except a Medication Guide) that is for distribution to patients – minimum 8-point type.

Medication Guide that is for distribution to patients – minimum 10-point type.

There is no requirement for a specific font type for labeling, but the font type should be clear and legible.

Narrow font types (e.g., Arial Narrow) are not recommended because they are difficult to read.

Some subsections are required. The use of additional subsection headings is encouraged to help organize the content.

Subheadings under a subsection may be used to help organize information, but they should not be assigned a numerical identifier.

Any section, subsection, or specific information that is clearly inapplicable must be omitted from labeling. Cross-referencing is encouraged, and in some cases required.

The preferred presentation of cross-references in Highlights is the numerical identifier in parentheses following the summarized labeling information.