Anti-Dandruff Shampoo Manufacturing: Cosmetic vs Medicinal Actives and What You Can Claim

An anti-dandruff shampoo can be manufactured as a cosmetic or as a medicinal product, and the route depends on the active ingredient, the claims and the market where it is sold. Some anti-dandruff actives are regulated as drugs in certain countries, so brands should choose the regulatory route first and the formula second.

Flaking and an itchy-feeling scalp are among the most common reasons people switch shampoo, which makes anti-dandruff a tempting category for new brands. It is also the haircare category where regulation differs most from one country to the next. This guide explains the general landscape so that you can have a sharper conversation with your haircare manufacturer in India and with a regulatory adviser in each market you plan to sell in. It is general information, not legal advice.

Why anti-dandruff is a borderline category

Dandruff is commonly linked to an imbalance on the scalp involving yeasts that live there naturally, along with sebum and skin-cell turnover. A product that claims to treat a condition or act on micro-organisms in the body can fall within the definition of a medicine in many countries. A product that cleanses the scalp and removes visible flakes generally sits within the definition of a cosmetic.

So two products with similar formulas can be regulated differently depending on what the label says. The active ingredient and its concentration matter too, because some actives are permitted in cosmetics only within limits, and some are not permitted in cosmetics at all in certain markets.

How actives are treated: a general view

The table below summarises broad patterns only. Rules change, and the precise status of each ingredient, its maximum level and permitted product types should be confirmed for every destination.

Active	General position
Ketoconazole	An antifungal generally regulated as a medicine in many markets, including India, so it is not a cosmetic route active.
Zinc pyrithione	Widely used historically in anti-dandruff shampoos. It is no longer permitted in cosmetic products in the European Union. In the United States, anti-dandruff shampoos are regulated as over-the-counter drug products and must follow the relevant rules. Its status elsewhere varies.
Selenium sulphide, coal tar	Typically associated with medicinal or over-the-counter drug routes in several markets.
Piroctone olamine, climbazole	Used in cosmetic anti-dandruff shampoos in some markets, subject to concentration limits and product-type restrictions.
Salicylic acid	Used in scalp-care products for its exfoliating action; permitted levels and claims differ by market and product type.
Botanicals (tea tree, neem, rosemary and similar)	Generally cosmetic ingredients, but the claims made about them still determine how the product is classified.

For consumer-level background on two of these actives, see our article on ketoconazole and zinc pyrithione shampoo.

What a cosmetic anti-dandruff shampoo can claim

Cosmetic claims describe cleansing, appearance and feel. They should be truthful, supported by evidence appropriate to the claim and consistent with local rules. Typical cosmetic-style wording includes:

• "Helps remove visible flakes with regular use"
• "Cleanses the scalp and leaves it feeling fresh"
• "Reduces the appearance of dandruff"
• "Soothes the feeling of a dry, tight scalp"
• "Gentle enough for frequent washing"

Wording to avoid on a cosmetic

Language that implies treatment, cure or action against a disease or micro-organism moves a product towards the medicinal side. Avoid phrases such as "cures dandruff", "treats seborrhoeic dermatitis", "kills fungus", "antifungal" or "stops hair fall caused by dandruff" on a cosmetic. Avoid "clinically proven" and "dermatologist recommended" unless you genuinely hold the specific evidence the phrase implies and your market permits it.

Building a cosmetic scalp-care shampoo

Many brands choose a cosmetic scalp-care position rather than a medicinal one, because it is simpler to register, label and sell across marketplaces. A well-made cosmetic scalp shampoo usually combines:

1. An effective but balanced surfactant system that removes oil and loose flakes without leaving the scalp feeling stripped.
2. A cosmetic anti-flake ingredient permitted in your markets, at a level within the applicable limits.
3. Soothing and refreshing agents such as menthol, panthenol, aloe or botanical extracts.
4. Light conditioning so the lengths are not left dry by a scalp-focused cleanse.
5. A considered fragrance; many scalp shampoos use fresh, herbal or mint notes.

You can see cosmetic starting points in our shampoo collection, and companion leave-on products in hair serums and tonics.

A regulatory check, market by market

Before you lock the formula, work through these questions for each country you will sell in:

• Is each active permitted in cosmetics, and at what maximum concentration and in which product types?
• Do any of your intended claims make the product a drug or medicine under local rules?
• Are there mandatory warnings, such as avoiding contact with eyes?
• Does the product need registration, notification or a local responsible person before sale?
• Will marketplaces you sell on ask for supporting documents or restrict certain claims?

If you plan to export, our guide to exporting haircare from India covers labelling and documentation at a general level.

Substantiation and testing

Even cosmetic claims need support. Depending on the claim, that might be ingredient literature, in-use consumer perception studies or instrumental assessment arranged with a testing partner. Keep the claim no stronger than the evidence. Formulas can be supplied as dermatologically tested, and test reports are available on request; details are on our testing and quality page.

Building a scalp-care routine around the shampoo

A single shampoo can launch a scalp-care line, but customers often look for a routine. Consider pairing the shampoo with a lightweight conditioner that keeps conditioning agents on the lengths rather than the scalp, a leave-on scalp tonic with a cooling feel, and an occasional exfoliating scalp treatment. Keep every product in the routine on the same side of the cosmetic line, with consistent claims across the set, so that one bold claim on a tonic does not undermine the classification of the whole range.

How we approach anti-dandruff projects

• We discuss your target markets and intended claims at the brief stage, before sampling.
• Cosmetic scalp-care formulas are available from the library from 500 units per product, with custom fragrance and packaging.
• Custom formulation is available where your brief needs a specific active profile within cosmetic limits.
• Products are made in a GMP-compliant, ISO certified facility.
• Samples are supplied before any order so you can assess lather, rinse and scalp feel.

Where a product needs to be registered as a medicine or over-the-counter drug in your market, that route carries separate licensing and approval requirements, and you should take specialist regulatory advice before committing.

Frequently asked questions

Can a cosmetic shampoo claim to treat dandruff?

In many markets, claims to treat or cure dandruff, or to act against fungus, push a product into the medicinal category. Cosmetic shampoos usually describe removing visible flakes, cleansing and refreshing the scalp. Check the rules in each market.

Is zinc pyrithione allowed in cosmetic shampoo?

It is no longer permitted in cosmetic products in the European Union, and in the United States anti-dandruff shampoos are regulated as over-the-counter drugs. Its status differs elsewhere, so confirm for every destination.

Which anti-dandruff actives can be used in cosmetics?

Depending on the market, ingredients such as piroctone olamine, climbazole and salicylic acid are used in cosmetic scalp products within concentration limits. Botanicals are also common. Permitted levels and claims vary by country.

Do you provide samples of scalp-care shampoos?

Yes. Samples are supplied before any order, so you can judge lather, rinse, scalp feel and fragrance before choosing a formula.

Planning a scalp-care range? Start with our private label haircare manufacturing page.