NDC 0299-5950 Tri-luma

Fluocinolone Acetonide,Hydroquinone,And Tretinoin Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0299-5950
Proprietary Name:
Tri-luma
Non-Proprietary Name: [1]
Fluocinolone Acetonide, Hydroquinone, And Tretinoin
Substance Name: [2]
Fluocinolone Acetonide; Hydroquinone; Tretinoin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Galderma Laboratories, L.p.
    Labeler Code:
    0299
    FDA Application Number: [6]
    NDA021112
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-18-2002
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0299-5950-02

    Package Description: 1 TUBE in 1 BLISTER PACK / 3 g in 1 TUBE

    NDC Code 0299-5950-30

    Package Description: 1 TUBE in 1 CARTON / 30 g in 1 TUBE

    Price per Unit: $7.14919 per GM

    Product Details

    What is NDC 0299-5950?

    The NDC code 0299-5950 is assigned by the FDA to the product Tri-luma which is a human prescription drug product labeled by Galderma Laboratories, L.p.. The generic name of Tri-luma is fluocinolone acetonide, hydroquinone, and tretinoin. The product's dosage form is cream and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 0299-5950-02 1 tube in 1 blister pack / 3 g in 1 tube, 0299-5950-30 1 tube in 1 carton / 30 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Tri-luma?

    This combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness. This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (e.g., sunlight, estrogen-type birth control hormones) may cause it to return.

    What are Tri-luma Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • FLUOCINOLONE ACETONIDE .1 mg/g - A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)
    • HYDROQUINONE 40 mg/g
    • TRETINOIN .5 mg/g - An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).

    Which are Tri-luma UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Tri-luma Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Tri-luma?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1191262 - fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream
    • RxCUI: 1191262 - fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream
    • RxCUI: 1191264 - Tri-Luma 0.01 % / 4 % / 0.05 % Topical Cream
    • RxCUI: 1191264 - fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]
    • RxCUI: 1191264 - Tri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream

    Which are the Pharmacologic Classes for Tri-luma?

    * Please review the disclaimer below.

    Patient Education

    Fluocinolone Topical


    Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
    [Learn More]


    Tretinoin Topical


    Tretinoin (Altreno, Atralin, Avita, Retin-A) is used to treat acne. Tretinoin is also used to reduce fine wrinkles (Refissa and Renova) and to improve spotty discoloration (Renova) and rough feeling skin (Renova) when used along with other skin care and sunlight avoidance programs. Tretinoin is in a class of medications called retinoids. It works by promoting peeling of affected skin areas and unclogging pores.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".