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All Containers›Shop by use case›Hair care›The monograph›The actives and the concentrationsShop all hair care →
The monograph

The actives and the concentrations

By Dwight Davis, Founder

On this page11
The monograph names them and gives the ranges to the tenth of a percent.

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, or micronized at 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 and salicylic acid 1.8 to 3 percent. A shorter list, which is worth noticing before writing a psoriasis claim.

Note the wash-off and leave-on split

Pyrithione zinc has two ranges depending on whether the product is rinsed out. A leave-in conditioner and a shampoo with the same active are different products under the monograph.

Which maps onto two of our leaves

Shampoo is wash-off and leave-in is leave-on. The same active at the same concentration can be inside the monograph in one and outside it in the other.

And the dandruff and seborrheic ranges differ

Pyrithione zinc wash-off is 0.3 to 2 percent for dandruff and 0.95 to 2 percent for seborrheic dermatitis. A product at 0.5 percent can claim one and not the other.

The concentration is a formulation decision with a label effect

Being inside a range is what lets you use the monograph. Being outside it, even above it, takes the product out of the monograph route entirely.

Coal tar appears in all three lists

Which makes it the broadest active here, and it carries an extra warning about sun sensitivity that the others do not.

This is not a formulation service

The ranges are from the regulation and the chemistry is not ours. What this property can tell you is that the ranges exist, where they are, and that they decide your route.

What it means for packaging

An active at a monograph concentration means a Drug Facts panel, which means label area, which means the bottle. That is the chain this property follows.

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
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.