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Medicine

Tri-luma 0.1 mg/40 mg/0.5 mg per g cream

Fluocinolone acetonide, Hydroquinone and Tretinoin · Topical · Galderma Laboratories
Available on requestPrescription onlyUS FDA Cold chain

Tri-luma 0.1 mg/40 mg/0.5 mg per g cream is a prescription medicine containing Fluocinolone acetonide, Hydroquinone and Tretinoin for topical use, marketed by Galderma Laboratories, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.

Key facts

Active ingredient (INN)
Fluocinolone acetonide, Hydroquinone and Tretinoin
Brand
Tri-luma
Strength
0.1 mg/40 mg/0.5 mg per g
Dosage form
Cream
Route
Topical
Packs
1 tube
Marketing authorisation holder
Galderma Laboratories
Manufacturer
Galderma Laboratories
Origin register
US FDA, United States
Storage
Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.32Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 January 2002
Identifiers
RxCUI 1191262, 1191264DailyMed set ID a35fa709-5eb5-4429-b38f-f1e0019bf0eeNDC 0299-5950Application NDA021112

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
1 tube in 1 carton / 30 g in 1 tube0299-5950-30Galderma Laboratories18 January 2007

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 18 January 2002Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Clinical summary

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

Read about Fluocinolone acetonide, Hydroquinone and Tretinoin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Tri-luma 0.1 mg/40 mg/0.5 mg per g cream for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.