Is Pramoxine HCl safe in cosmetics?
Pramoxine HCl has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: restricted.
Moderate
Cosmetic Ingredient
Pramoxine HCl
Also known as: 4-(3-(p-Butoxyphenoxy)propyl)morpholine hydrochloride, p-Butoxyphenyl gamma-morpholinopropyl ether hydrochloride, EINECS 211-293-1, gamma-Morpholinopropyl 4-n-butoxyphenyl ether hydrochloride, NSC 25573 (+2 more)
INCI: PRAMOXINE HCL
Pramoxine HCl (CAS 637-58-1) is a cosmetic cosmetic ingredient functioning as Topical anesthetic / anti-itch agent (skin conditioning). EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 637-58-1 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Pramoxine HCl is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335).
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
Topical anesthetic / anti-itch agent (skin conditioning)
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
4-[3-(4-butoxyphenoxy)propyl]morpholine;hydrochloride
InChIKey
SYCBXBCPLUFJID-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
restricted
US Notes
OTC monograph drug (active ingredient); restricted to 0.5–1% in OTC anti-itch/skin protectant products. Not classified as a cosmetic ingredient by FDA — product use classifies it as a drug requiring drug labeling and GMP drug manufacturing.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Pramoxine HCl.
Calculate MoS for your specific formulation with the MoS Calculator.
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| KR | prohibited | - | - |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Expert Verdict
Expert safety assessment and concern-level summary for Pramoxine HCl.
Known Synonyms
4-(3-(p-Butoxyphenoxy)propyl)morpholine hydrochloride
p-Butoxyphenyl gamma-morpholinopropyl ether hydrochloride
EINECS 211-293-1
gamma-Morpholinopropyl 4-n-butoxyphenyl ether hydrochloride
NSC 25573
Prax Lotion
UNII-88AYB867L5
Chemical Function
Antioxidant
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
PRAMOXINE HYDROCHLORIDE
ChEMBL ID
CHEMBL1201171
Max Phase
4
Frequently Asked Questions
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.
Is Pramoxine HCl used outside cosmetics?
Pramoxine HCl also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Pramoxine HCl have different safety status in cosmetics vs industrial chemicals?
Pramoxine HCl is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335).
Compliance Tools
Check Pramoxine HCl compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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