Regulatory Status
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Safety Data
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Expert Verdict
Prohibited in EU cosmetics. In the US, use as an active ingredient classifies the product as an OTC drug rather than a cosmetic, requiring drug labeling and compliance with GMP drug manufacturing standards.
Frequently Asked Questions
Is Pramoxine HCl safe in cosmetics?
Prohibited in EU cosmetics. In the US, use as an active ingredient classifies the product as an OTC drug rather than a cosmetic, requiring drug labeling and compliance with GMP drug manufacturing standards. The EU classifies Pramoxine HCl as "prohibited". Safety rating: MODERATE.
Is Pramoxine HCl allowed in the EU?
Pramoxine HCl EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Pramoxine HCl do in cosmetics?
Pramoxine HCl functions as: Topical anesthetic / anti-itch agent (skin conditioning). It is classified as a cosmetic ingredient in our database. CAS number: 637-58-1.
What is the Margin of Safety for Pramoxine HCl?
adequate 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
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Related Ingredients
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