Fixed-dose combination
Fluocinolone acetonide, Hydroquinone and Tretinoin is a fixed-dose combination of a corticosteroid, a melanin synthesis inhibitor and a retinoid. It is available as cream for topical use. MedsAcross supplies Fluocinolone acetonide, Hydroquinone and Tretinoin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TRI-LUMA Cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
Source: US FDA prescribing information
The mechanism of action of the active ingredients in TRI-LUMA Cream in the treatment of melasma is unknown.
Source: US FDA prescribing information
Apply a thin film of TRI-LUMA Cream to the effected area once daily, at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply TRI-LUMA Cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. Therapy should be discontinued when control is achieved. During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. TRI-LUMA Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected area once daily, at least 30 minutes before bedtime.
Source: US FDA prescribing information
TRI-LUMA Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.
Source: US FDA prescribing information
TRI-LUMA Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. If anaphylaxis, asthma or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue TRI-LUMA. TRI-LUMA Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy.
Source: US FDA prescribing information
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the controlled clinical trials, adverse events were monitored in the 161 subjects who used TRI-LUMA Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity.
Source: US FDA prescribing information
Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Fluocinolone acetonide, Hydroquinone and Tretinoin, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Tri-luma 0.1 mg/40 mg/0.5 mg per g creamTopical Cold chain | Fluocinolone acetonide, Hydroquinone and Tretinoin | Galderma Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 18 January 2002 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Fluocinolone acetonide, Hydroquinone and Tretinoin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fluocinolone acetonide, Hydroquinone and Tretinoin, including Tri-luma.
Yes. The US FDA first approved Fluocinolone acetonide, Hydroquinone and Tretinoin on 18 January 2002, according to Drugs@FDA.
At least one listed presentation of Fluocinolone acetonide, Hydroquinone and Tretinoin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.