Mafenide HCl

INCI: MAFENIDE HCL

CAS Number
138-37-4
Function
Antimicrobial agent (sulfonamide-type)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA-approved as a prescription drug (topical burn treatment). Use in cosmetics would likely trigger drug classification under the FD&C Act if antimicrobial claims are made

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

Can cause metabolic acidosis by inhibiting carbonic anhydrase; known to cause pain/burning at application site; potential for hypersensitivity reactions (sulfonamide allergy); not a typical cosmetic ingredient. Molecular formula C₇H₁₁ClN₂O₂S; the hydrochloride salt of mafenide (4-aminomethylbenzenesulfonamide); bacteriostatic against Gram-positive and Gram-negative organisms including Pseudomonas aeruginosa

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Concern Level: Moderate

Frequently Asked Questions

Is Mafenide HCl safe in cosmetics?

Can cause metabolic acidosis by inhibiting carbonic anhydrase; known to cause pain/burning at application site; potential for hypersensitivity reactions (sulfonamide allergy); not a typical cosmetic ingredient. Molecular formula C₇H₁₁ClN₂O₂S; the hydrochloride salt of mafenide (4-aminomethylbenzenesulfonamide); bacteriostatic against Gram-positive and Gram-negative organisms including Pseudomonas aeruginosa The EU classifies Mafenide HCl as "permitted". Safety rating: MODERATE.

Is Mafenide HCl allowed in the EU?

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

What does Mafenide HCl do in cosmetics?

Mafenide HCl functions as: Antimicrobial agent (sulfonamide-type). It is classified as a cosmetic ingredient in our database. CAS number: 138-37-4.

What is the Margin of Safety for Mafenide HCl?

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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