Trianex Ointment

Name: Trianex Ointment

Trianex Ointment Description

Topical corticosteroids, such as Trianex® 0.05% (Triamcinolone Acetonide Ointment, USP), constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Each gram of Trianex® 0.05% (Triamcinolone Acetonide Ointment, USP) contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, and Lanolin Alcohols NF. The white ointment is for topical use only.

Triamcinolone Acetonide has the molecular formula of C24H31FO6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-. It has a molecular weight of 434.50 and the following structural formula:

Contraindications

Trianex® 0.05% (Triamcinolone Acetonide Ointment, USP) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae and Miliaria.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

PRINCIPAL DISPLAY PANEL - 430 g Jar


NDC 67857-806-19

Trianex® 0.05%

(Triamcinolone Acetonide Ointment, USP)

Proprietary Hydrous Emulsified Base

Rx Only

430 g


TRIANEX 0.05% 
triamcinolone acetonide ointment ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67857-806
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
triamcinolone acetonide (Triamcinolone Acetonide) triamcinolone acetonide 0.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Light Mineral Oil  
Water  
Petrolatum  
Mineral Oil  
Ceresin  
Lanolin Alcohols  
Packaging
# Item Code Package Description
1 NDC:67857-806-19 430 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089595 02/18/2015
Labeler - Promius Pharma, LLC (020408265)
Registrant - Promius Pharma, LLC (020408265)
Establishment
Name Address ID/FEI Operations
Sicor Societa' Italiana Corticosteroidi s.r.l 429369713 api manufacture(67857-806)
Establishment
Name Address ID/FEI Operations
CMP Pharma, Inc. 005224175 manufacture(67857-806)
Revised: 05/2011   Promius Pharma, LLC
(web3)