NDC Code(s) : 45802-443-01
Packager : Perrigo New York Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Triamcinolone Acetonide GlucocorticoidTriamcinolone acetonide SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-443
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE(UNII: F446C597KA)
(TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) 		TRIAMCINOLONE ACETONIDE55 ug
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-443-011 in 1 CARTON 17/08/2016
1120 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078104 08/17/2016

PRINCIPAL DISPLAY PANEL

Compare to Nasacort® Allergy 24 HR active ingredient

Multi-Symptom

Nasal Allergy Spray

Triamcinolone Acetonide (Glucocorticoid) 55 mcg per spray

Nasal Allergy Symptom Reliever

24 Hour Relief of:

Nasal Congestion

Sneezing

Runny Nose

Itchy Nose

0.57 FL OZ (16.9 mL)

Original Prescription Strength

120 SPRAYS

Perrigo Triamcinolone Acetonide (Glucocorticoid) image