Moderate Cosmetic Ingredient

Mirodenafil

INCI: MIRODENAFIL

CAS Number
862189-95-5
Function
Skin conditioning (as listed in CosIng/COSMILE)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Not approved as a cosmetic ingredient - As a PDE5 inhibitor, if a product containing mirodenafil makes drug claims or has pharmacological activity, the FDA would classify it as an unapproved drug. The FDA has issued warning letters to products containing undeclared PDE5 inhibitors

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Major - cardiovascular effects (hypotension, especially with nitrates), headache, flushing, visual disturbances. This is an active pharmaceutical ingredient (API) and has no established safe-use profile as a cosmetic. Its presence in cosmetic products would be a serious regulatory red flag. Pyrimidine-derivative PDE5 inhibitor developed by SK Chemicals in South Korea. Despite its CosIng listing, its pharmacological potency makes it inappropriate for cosmetic use. Any formulation containing th...

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Concern Level: Moderate

Frequently Asked Questions

Is Mirodenafil safe in cosmetics?

Major - cardiovascular effects (hypotension, especially with nitrates), headache, flushing, visual disturbances. This is an active pharmaceutical ingredient (API) and has no established safe-use profile as a cosmetic. Its presence in cosmetic products would be a serious regulatory red flag. Pyrimidine-derivative PDE5 inhibitor developed by SK Chemicals in South Korea. Despite its CosIng listing, its pharmacological potency makes it inappropriate for cosmetic use. Any formulation containing th... The EU classifies Mirodenafil as "permitted". Safety rating: MODERATE.

Is Mirodenafil allowed in the EU?

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

What does Mirodenafil do in cosmetics?

Mirodenafil functions as: Skin conditioning (as listed in CosIng/COSMILE). It is classified as a cosmetic ingredient in our database. CAS number: 862189-95-5.

What is the Margin of Safety for Mirodenafil?

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.

Compliance Tools

Check Mirodenafil compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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