Prescription medicine
Fluocinolone and hydroquinone and tretinoin Brand names: Tri-Luma
Fluocinolone and hydroquinone and tretinoin (Tri-Luma) is a prescription medicine with an FDA approval on record since 2002. No generic is listed; pharmacies paid $7.83 per gram (Tri-luma cream) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the fluocinolone and hydroquinone and tretinoin FDA label on DailyMed (effective October 24, 2024, Galderma Laboratories, L.P.); the NDA 21112 record on Drugs@FDA; every fluocinolone and hydroquinone and tretinoin label on DailyMed.
Highlights of the record
FDA label of October 24, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTRI-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.
Forms and strengths
- 0.1 mg/g / 40 mg/g / 0.5 mg/g
Cream.
On the market
- Earliest approval on file
- January 18, 2002 Tri-Luma, Galderma Labs Lp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $7.83 per gram Tri-luma cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 544 through July 30, 2026
What is fluocinolone and hydroquinone and tretinoin used for?
From the label: indications and usageTRI-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. […]
FDA pharmacologic class: Corticosteroid, Melanin Synthesis Inhibitor and Retinoid.
Source: FDA drug label (TRI-LUMA), Galderma Laboratories, L.P., effective October 24, 2024 (SPL set a35fa709-5eb5-4429-b38f-f1e0019bf0ee), via openFDA; the full label on DailyMed
What does the patient leaflet for fluocinolone and hydroquinone and tretinoin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRI-LUMA Cream?TRI-LUMA Cream may cause birth defects or death of the baby if used during pregnancy. The risk of birth defects or death of the baby may be greater if TRI-LUMA Cream is used during the first trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using TRI-LUMA Cream, tell your doctor right away.
From the patient leaflet: What should I avoid while using TRI-LUMA Cream?You should avoid sunlight, sunlamps, tanning beds, and ultraviolet light during treatment with TRI-LUMA Cream. Use a sunscreen with SPF (sun protection factor) of 30 or more. If you have to be in the sunlight, wear a wide-brimmed hat or other protective clothing to cover the treated areas. Melasma can get worse with even a small amount of sunlight. You should continue to avoid sunlight, use sunscreen, and wear protective clothing after treatment with TRI-LUMA Cream. Females should avoid the use of hormonal forms of birth control. Hormonal birth control methods can cause your melasma to become worse. Talk to your doctor about other birth control options. Heat and cold weather may irritate skin treated with TRI-LUMA. Talk with your doctor about ways to manage skin irritation.
From the patient leaflet: How should I store TRI-LUMA Cream?Store TRI-LUMA Cream in a refrigerator, between 36°F to 46°F (2°C to 8 °C). Keep TRI-LUMA Cream tube tightly closed. Do not freeze TRI-LUMA Cream.
Source: FDA drug label (TRI-LUMA), Galderma Laboratories, L.P., effective October 24, 2024 (SPL set a35fa709-5eb5-4429-b38f-f1e0019bf0ee), via openFDA; the full label on DailyMed
Is there a generic for fluocinolone and hydroquinone and tretinoin (Tri-Luma)?
No generic fluocinolone and hydroquinone and tretinoin is approved (Drugs@FDA, October 8, 2026).
- 2002 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluocinolone and hydroquinone and tretinoin (Tri-Luma)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.83 per gram (Tri-luma cream), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tri-luma cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tri-luma cream | Brand | $7.83 per gram | n/a | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the fluocinolone and hydroquinone and tretinoin label say about other medicines?
The fluocinolone and hydroquinone and tretinoin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cosyntropin | warnings and precautions | The ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression. |
Check fluocinolone and hydroquinone and tretinoin against other medicines
Source: FDA drug label (TRI-LUMA), Galderma Laboratories, L.P., effective October 24, 2024 (SPL set a35fa709-5eb5-4429-b38f-f1e0019bf0ee), via openFDA; the full label on DailyMed
What do FAERS reports show for fluocinolone and hydroquinone and tretinoin?
The FDA Adverse Event Reporting System holds 544 reports that list fluocinolone and hydroquinone and tretinoin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluocinolone and hydroquinone and tretinoin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other