Getting started

Cosmetic or drug

On this page11

The line Which is why a shampoo can be either Scalp treatment is the leaf that lives here And there is a monograph waiting on the other side Which is a better position than it sounds Outside the monograph is a different world Hair loss is the commonest way out of it A cosmetic has its own obligations The packaging consequence is the point of this property So the claim decides the bottle References

The formula does not decide this. The claim does.

The line

A cosmetic cleans, beautifies or changes appearance. A drug treats or prevents a condition or affects the structure or function of the body. Intended use is what places a product, and intended use is established by what you say about it.

Which is why a shampoo can be either

The same surfactant base is a cosmetic when it cleans hair and a drug when it controls dandruff. Nothing in the bottle changed; the claim on the bottle did.

Scalp treatment is the leaf that lives here

It is one of the eleven in this group and it is the one most likely to carry a claim that crosses. "Soothes the scalp" and "controls the symptoms of seborrheic dermatitis" are different kinds of sentence.

And there is a monograph waiting on the other side

21 CFR part 358 subpart H covers dandruff, seborrheic dermatitis and psoriasis. A product inside the monograph can be marketed without a premarket approval, on the monograph's terms.

Which is a better position than it sounds

The monograph names the permitted actives and their concentrations and gives the label wording. It is a route to market with the answers written down, which is rare.

Outside the monograph is a different world

A different active, a higher concentration, or a claim the monograph does not cover, and you are outside it. That is a new drug question rather than a labeling question.

Hair loss is the commonest way out of it

A claim about growing hair is not in this monograph, and this property says nothing about where it does belong. That is a question to take to somebody who does regulatory work for a living.

A cosmetic has its own obligations

Ingredient declaration, facility registration and product listing among them. Those are covered in the grooming property and this one does not repeat them.

The packaging consequence is the point of this property

A drug carries a Drug Facts panel with type sizes set in the regulation, and there is a clause about what happens when that panel needs more than 60 percent of your label area.

So the claim decides the bottle

Not immediately and not obviously, but it does. A product whose label has to carry a Drug Facts panel needs a different container from one whose label carries a story.

References

21 CFR 358.710, active ingredients of the dandruff, seborrheic dermatitis and psoriasis monograph. For dandruff: coal tar 0.5 to 5 percent; pyrithione zinc 0.3 to 2 percent in a wash-off formulation and 0.1 to 0.25 percent leave-on; salicylic acid 1.8 to 3 percent; selenium sulfide 1 percent and micronized selenium sulfide 0.6 percent; sulfur 2 to 5 percent. For seborrheic dermatitis: coal tar 0.5 to 5 percent; pyrithione zinc 0.95 to 2 percent wash-off and 0.1 to 0.25 percent leave-on; salicylic acid 1.8 to 3 percent; selenium sulfide 1 percent. For psoriasis: coal tar 0.5 to 5 percent; salicylic acid 1.8 to 3 percent. 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.