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Annex II Entry 405 20/10/2010

Pramocaine (INN)

Pramocaine (INN) is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 405

Chemical identity and properties

PubChem 2D chemical structure for CAS 140-65-8
CAS 140-65-8PubChem CID 4886

Pramoxine

Pramocaine is a member of the class of morpholines that is morpholine substituted at the nitrogen atom by a 3-(4-butoxyphenoxy)propyl group. It has a role as a local anaesthetic. It is an aromatic ether and a member of morpholines. — ChEBI

IUPAC name
4-[3-(4-butoxyphenoxy)propyl]morpholine
Molecular formula
C17H27NO3
Molecular weight
293.4 g/mol
Exact mass
293.19909372 Da
XLogP3
3.1
Topological polar surface area
30.9 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
4
Covalent units
1
Defined stereocentres
0

Also known as

PramocaineProxazocainpramocainumPramocaina4-(3-(p-Butoxyphenoxy)propyl)morpholinep-Butoxyphenyl gamma-morpholinopropyl ethergamma-Morpholinopropyl 4-n-butoxyphenyl ether4-(3-(4-butoxyphenoxy)propyl)morpholine
16 more reported names
CHEBI:8357068X84E056RefChem:55901C05AD07D04AB07205-425-7TronopthaneMorpholine, 4-(3-(p-butoxyphenoxy)propyl)-Pramocaine (INN)PRAMOCAINE [INN]Morpholine, 4-[3-(4-butoxyphenoxy)propyl]-Pramocaine [INN:BAN]Pramocainum [INN-Latin]Pramocaina [INN-Spanish]EINECS 205-425-7BRN 0239059
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External database identifiers

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Pramocaine (INN)

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Identified ingredients

Key data

CAS
140-65-8
EC
205-425-7
Annex
II
Entry number
405

Inventory links for Pramocaine (INN)

Inventory Restriction reference
Ref 58385

PRAMOXINE HCL

CAS: 637-58-1
EC: 211-293-1

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

Annex II 409
Nearby record in the same annex

Pyrogallol

CAS: 87-66-1
EC: 201-762-9
Annex II 400
Nearby record in the same annex

1,2-Epoxybutane

CAS: 106-88-7
EC: 203-438-2
Annex II 399
Nearby record in the same annex

Lidocaine (INN)

CAS: 137-58-6
EC: 205-302-8

What Annex II means for Pramocaine (INN)

Pramocaine (INN) is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.

Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.

This record is linked to 1 CosIng inventory ingredient for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Verify this substance is absent from all raw materials and finished formulations.
  • Request absence confirmation or CoA from raw material suppliers.
  • Document the screening result in the Product Information File (PIF).

Frequently asked questions

Yes. Pramocaine (INN) is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.

CAS 140-65-8 is the unique numerical identifier assigned to Pramocaine (INN) by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex II record Pramocaine (INN)

This page summarizes one Annex II record for Pramocaine (INN) from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex II conditions for Pramocaine (INN), but confirm any final regulatory decision against the current official annex wording and source files.

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