NDC 0299-5950 Tri-luma
Fluocinolone Acetonide,Hydroquinone,And Tretinoin Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0299 - Galderma Laboratories, L.p.
- 0299-5950 - Tri-luma
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?
What are the uses for Tri-luma?
What are Tri-luma Active Ingredients?
- 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:
- FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M)
- FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (Active Moiety)
- HYDROQUINONE (UNII: XV74C1N1AE)
- HYDROQUINONE (UNII: XV74C1N1AE) (Active Moiety)
- TRETINOIN (UNII: 5688UTC01R)
- TRETINOIN (UNII: 5688UTC01R) (Active Moiety)
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:
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- CETYL ALCOHOL (UNII: 936JST6JCN)
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- GLYCERIN (UNII: PDC6A3C0OX)
- GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
- MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
- METHYL GLUCETH-10 (UNII: N0MWT4C7WH)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- PEG-100 STEARATE (UNII: YD01N1999R)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- WATER (UNII: 059QF0KO0R)
- SODIUM METABISULFITE (UNII: 4VON5FNS3C)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
What is the NDC to RxNorm Crosswalk for Tri-luma?
- 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?
- Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
- Corticosteroid - [EPC] (Established Pharmacologic Class)
- Depigmenting Activity - [PE] (Physiologic Effect)
- Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
- Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
- Retinoid - [EPC] (Established Pharmacologic Class)
- Retinoids - [CS]
* 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.
[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".