Tri-luma Cream
NDC 0299-5950

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0299-5950?
  4. Tri-luma Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Tri-luma (fluocinolone acetonide, hydroquinone, and tretinoin) is a NDA-approved product labeled by Galderma Laboratories, L.p.. This combination medication is used to treat melasma on the face. It is supplied as a cream for topical administration. This product entry covers the primary NDC 0299-5950 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Galderma Laboratories, L.p.
Labeler Code:
0299
Product Label ID:
a35fa709-5eb5-4429-b38f-f1e0019bf0ee
FDA Application Number: [6]
NDA021112
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-18-2002
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0299-5950?

The NDC code 0299-5950 is assigned by the FDA to the product Tri-luma. It is commonly known by its generic name, fluocinolone acetonide, hydroquinone, and tretinoin. This pharmaceutical product is labeled by Galderma Laboratories, L.p. and is currently categorized as listed product. The medication is a cream administered via topical route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0299-5950-02, 0299-5950-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 - Derivatives of hydroquinone (1,4-dihydrobenzene) made by reduction of BENZOQUINONES.
  • 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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 of this product?

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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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".