NDC Code(s) : 54868-6270-0
Packager : Physicians Total Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Triamcinolone Acetonide Triamcinolone Acetonide SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6270(NDC:0093-2085)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE(UNII: F446C597KA)
(TRIAMCINOLONE - UNII:1ZK20VI6TY) 		TRIAMCINOLONE ACETONIDE55 ug
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54868-6270-01 in 1 CARTON
1120 in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078104 09/14/2011

LABELER - Physicians Total Care, Inc.(194123980)

Establishment
Name Address ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel, repack

PRINCIPAL DISPLAY PANEL

Triamcinolone Acetonide Nasal Spray 0.055 mg/spray

NDC 54868-6270-0

image of package label

TRIAMCINOLONE

ACETONIDE

Nasal Spray

0.055 mg/spray

FOR INTRANASAL USE ONLY

SHAKE WELL BEFORE USING

Attention Pharmacist: DISPENSE WITH

INFORMATION FOR THE PATIENT

Rx only

One 16.5g Spray Bottle

120 Metered Actuations