The monograph

The words the monograph gives you

On this page11

The statement of identity The indication The general warnings The coal tar warning The two referral warnings The directions Which is a lot of mandated text And it has to be legible The brand story goes somewhere else Get the panel laid out before buying bottles References

The sentences are written for you, which is both a constraint and a gift.

The statement of identity

"[Dandruff] (insert product form)" or "antidandruff (insert product form)", with the equivalent constructions for seborrheic dermatitis and psoriasis. The product form is yours; the frame is not.

The indication

"(For relief of or Controls) the symptoms of" the condition. Controls, not cures, and symptoms, not the condition itself. That distinction is the whole monograph in two words.

The general warnings

"For external use only" and "Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water". Both on every product under this monograph.

The coal tar warning

"Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours." Specific to the active rather than the condition.

The two referral warnings

"If condition worsens or does not improve after regular use of this product as directed, consult a doctor" and "Do not use for prolonged periods without consulting a doctor".

The directions

For a wash-off product, "For best results use at least twice a week or as directed by a doctor". For a leave-on, "Apply to affected areas one to four times daily or as directed by a doctor".

Which is a lot of mandated text

Count it. Identity, indication, four or five warnings and a direction, in a specified order, inside a Drug Facts panel with its own type sizes. That is the label area problem in one paragraph.

And it has to be legible

No smaller than 6-point for the content, headings larger, and the title larger than anything in the panel. There is no option to set it in 4-point to make it fit.

The brand story goes somewhere else

Which is the real design consequence. On a 4 oz bottle with a Drug Facts panel, the panel wins and the marketing moves to a carton, a wrap or the back of a longer label.

Get the panel laid out before buying bottles

The order here matters: typeset the required text first, measure it, and then choose the container. Doing it the other way is how a label arrives that cannot be printed.

References

21 CFR 358.750, labeling. The statement of identity is "[Dandruff] (insert product form)" or "antidandruff (insert product form)", with the equivalent forms for seborrheic dermatitis and psoriasis. The indication is "(For relief of or Controls) the symptoms of" the condition. The general warnings are "For external use only" and "Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water". Coal tar carries "Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours". Both "If condition worsens or does not improve after regular use of this product as directed, consult a doctor" and "Do not use for prolonged periods without consulting a doctor" appear. Directions for a wash-off product are "For best results use at least twice a week or as directed by a doctor"; for a leave-on, "Apply to affected areas one to four times daily or as directed by a doctor". law.cornell.edu

21 CFR 201.66(d), the Drug Facts format. The title "Drug Facts" "shall appear in a type size larger than the largest type size used in the Drug Facts labeling". Headings are set at "the larger of either 8-point or greater type, or 2-point sizes greater than the point size of the text", and all other content is "no smaller than 6-point type". Paragraph (d)(10) relaxes the format where the Drug Facts labeling would occupy more than 60 percent of the available label space: a continuation title at no smaller than 7-point, headings at the larger of 7-point or one point over the text, reduced leading provided ascenders and descenders do not touch, bullets that need not be vertically aligned, and the enclosing box omitted where color contrast distinguishes the labeling. law.cornell.edu

Written from 21 CFR part 358 subpart H, 21 CFR 201.66 and the catalog as it stood on 18 October 2026. Whether a particular product is a cosmetic or a drug turns on its intended use, which is established by what you say about it; no page here can make that determination for you. Cosmetic labeling, facility registration and product listing are covered in the grooming property and not repeated.