Drug Facts Labeling

1. Drug Facts (title)
2. Active ingredient(s)–Note the lowercase “i” in ingredient. Companies must use USAN names only. This is followed by the dose or %, as stated in the Monograph. At the right is the purpose, again specified in the Monograph.
3. Purpose that is specified in the Monograph
4. Use or Uses, as specified in the Monograph
5. Warnings, as specified in the Monograph, along with FDA-mandated general warnings
6. Directions, as specified in the Monograph
7. Other information, which is optional
8. Inactive ingredients–Note the lowercase “i” in ingredients. Companies must use USAN names only and in alphabetical order if only making drug claims outside the Drug Facts label. If making any cosmetic claims, only the INCI names must be used in descending order of predominance, down to 1%—similar to a general cosmetic ingredient declaration.
9. Questions–This is also optional. If a phone number is listed, the FDA assumes that it is manned 24/7 by an individual unless designated times are stated.