The Department will offer informal comment on any proposed label and accompanying literature involving a hazardous substance if it is furnished with:
- (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.