Is Crotamiton registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Crotamiton, including CROTAPHIL 10% CREAM (10 %, Cream, SAR 7.55); CROTAPHIL 10% LOTION (10 %, Lotion, SAR 11.15).

Is Crotamiton approved by the US FDA?

Drugs@FDA lists 3 application product lines for Crotamiton, including EURAX (Prescription); CROTAN (Prescription); EURAX (Discontinued).

Active substance

Crotamiton

SFDA 4
US FDA 3
US price lines 1
NHS prices 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CROTAPHIL 10% CREAM	10 %	Cream · Topical	1 Tube	SAR 7.55	Generic · OTC	PHILADELPHIA PHARMACEUTICAL	Valid
CROTAPHIL 10% LOTION	10 %	Lotion · Topical	1 Tube	SAR 11.15	Generic · OTC	PHILADELPHIA PHARMACEUTICAL	Valid
EURAX CREAM 10%	10 %	Cream · Topical	1 Tube	SAR 10.35	NCE · OTC	NOVARTIS	Withdrawn by MAH · Not Marketed
EURAX LOTION 10%	10 %	Lotion · Topical	1 Bottle	SAR 17.25	NCE · OTC	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

SCABIES

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
EURAX	10%	cream · topical	JOURNEY	Prescription	6 Jul 1949
CROTAN	10%	lotion · topical	LEGACY	Prescription	16 Dec 1981
EURAX	10%	lotion · topical	JOURNEY	Discontinued	29 Apr 1955

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CROTAN 10% LOTION	$3.1167	per GM	17 Dec 2025
NHS Drug Tariff	Crotamiton 10% cream	£3.13	30 gram	1 Oct 2026
NHS Drug Tariff	Crotamiton 10% cream	£5.91	100 gram	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.