Is Fluocinolone + Hydroquinone + Tretinoin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Fluocinolone + Hydroquinone + Tretinoin, including Triolite (0.1,0.5,40 mg,mg,mg, Cream, SAR 63.10).

Is Fluocinolone + Hydroquinone + Tretinoin approved by the US FDA?

Drugs@FDA lists 1 application product line for Fluocinolone + Hydroquinone + Tretinoin, including TRI-LUMA (Prescription).

Active substances

Fluocinolone + Hydroquinone + Tretinoin

SFDA 1
US FDA 1
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Triolite	0.1,0.5,40 mg,mg,mg	Cream · Topical	1 Tube	SAR 63.10	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TRI-LUMA	0.01%;4%;0.05%	cream · topical	GALDERMA LABS LP	Prescription	18 Jan 2002

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRI-LUMA CREAM	$7.83363	per GM	23 Sep 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.

Components

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.