NDC 0299-5950

TRI-LUMA

Fluocinolone Acetonide, Hydroquinone, And Tretinoin

TRI-LUMA is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Fluocinolone Acetonide; Hydroquinone; Tretinoin.

Product ID0299-5950_00d67032-56e1-477a-9306-9e27d201bfda
NDC0299-5950
Product TypeHuman Prescription Drug
Proprietary NameTRI-LUMA
Generic NameFluocinolone Acetonide, Hydroquinone, And Tretinoin
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2002-01-18
Marketing CategoryNDA / NDA
Application NumberNDA021112
Labeler NameGalderma Laboratories, L.P.
Substance NameFLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Active Ingredient Strength0 mg/g; mg/g; mg/g
Pharm ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Retinoid [EPC], Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0299-5950-02

1 TUBE in 1 BLISTER PACK (0299-5950-02) > 3 g in 1 TUBE
Marketing Start Date2012-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0299-5950-30 [00299595030]

TRI-LUMA CREAM
Marketing CategoryNDA
Application NumberNDA021112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2007-01-18

NDC 0299-5950-02 [00299595002]

TRI-LUMA CREAM
Marketing CategoryNDA
Application NumberNDA021112
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-01

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.1 mg/g

OpenFDA Data

SPL SET ID:a35fa709-5eb5-4429-b38f-f1e0019bf0ee
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191262
  • 1191264
  • UPC Code
  • 0302995950309
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Melanin Synthesis Inhibitor [EPC]
    • Melanin Synthesis Inhibitors [MoA]
    • Depigmenting Activity [PE]
    • Retinoid [EPC]
    • Retinoids [CS]

    Trademark Results [TRI-LUMA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRI-LUMA
    TRI-LUMA
    75889914 2605369 Live/Registered
    NESTLÉ SKIN HEALTH S.A.
    2000-01-07

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