16 CFR 1500.128 - Label comment.
(a) Complete labeling or proposed labeling, which may be in draft form.
(b) Complete quantitative formula.
(c) Adequate clinical pharmacological, toxicological, physical, and chemical data applicable to the possible hazard of the substance.
(d) Any other information available that would facilitate preparation of a suitable label, such as complaints of injuries resulting from the product's use or other evidence that would furnish human-experience data.