Minoxidil

INCI: MINOXIDIL

CAS Number
38304-91-5
Function
vasodilator; hair-growth stimulant; potassium-channel opener
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes FDA-approved OTC drug for androgenetic alopecia: 2% approved for women (1991), 5% approved for men (1988). Not a cosmetic ingredient in the US โ€” classified as an OTC drug under monograph system. Adverse effects include allergic contact dermatitis.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Minoxidil is prohibited in EU cosmetics (Annex II, EC 1223/2009) and classified as an OTC drug in the US; not permissible as a cosmetic ingredient in any jurisdiction due to medicinal classification and documented allergic contact dermatitis risk.

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Concern Level: High

Regulatory Flags

prohibited-eu drug-not-cosmetic annex-ii otc-drug-us contact-dermatitis-risk eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Minoxidil safe in cosmetics?

Minoxidil is prohibited in EU cosmetics (Annex II, EC 1223/2009) and classified as an OTC drug in the US; not permissible as a cosmetic ingredient in any jurisdiction due to medicinal classification and documented allergic contact dermatitis risk. The EU classifies Minoxidil as "prohibited". Safety rating: MODERATE.

Is Minoxidil allowed in the EU?

Minoxidil EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Minoxidil do in cosmetics?

Minoxidil functions as: vasodilator; hair-growth stimulant; potassium-channel opener. It is classified as a Active Ingredient in our database. CAS number: 38304-91-5.

What is the Margin of Safety for Minoxidil?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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