---
kind: "section"
citation: "16 C.F.R. § 1500.128"
title: "16"
number: "1500.128"
heading: "Label comment."
url: "https://uscodex.org/cfr/16/1500.128"
---

# §1500.128. Label comment.


The Commission will offer informal comment on any proposed label and accompanying literature involving a hazardous substance if 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.

## Notes

### Authority

Authority: 15 U.S.C. 1261-1278.

### Source

Source: 38 FR 27012, Sept. 27, 1973, unless otherwise noted.