NDC Code(s) : 0245-0136-66, 0245-0136-17, 0245-0136-85
Packager : Upsher-Smith Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Trianextriamcinolone acetonide OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0136(NDC:46287-010)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
triamcinolone acetonide(UNII: F446C597KA)
(triamcinolone acetonide - UNII:F446C597KA) 		triamcinolone acetonide0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Light Mineral Oil(UNII: N6K5787QVP)
Water(UNII: 059QF0KO0R)
Petrolatum(UNII: 4T6H12BN9U)
Mineral Oil(UNII: T5L8T28FGP)
Ceresin(UNII: Q1LS2UJO3A)
Lanolin Alcohols(UNII: 884C3FA9HE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0136-6620 in 1 CARTON 27/05/2011
13 g in 1 TUBE Type 0: Not a Combination Product
2NDC:0245-0136-171 in 1 CARTON 27/05/2011
217 g in 1 TUBE Type 0: Not a Combination Product
3NDC:0245-0136-851 in 1 CARTON 27/05/2011
385 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089595 05/27/2011 07/31/2014

PRINCIPAL DISPLAY PANEL

NDC 0245-0136-85

Rx ONLY

Trianex™ 0.05%
(Triamcinolone Acetonide Ointment)
Proprietary Hydrous Emulsified Base

85 g (2.9 oz)

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 85 g Carton Label