TRIAMCINOLONE ACETONIDE- triamcinolone acetonide spray, metered 
Apotex Corp.

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Drug Facts

Active ingredient (in each spray)

Triamcinolone acetonide 55 mcg (glucocorticoid)

                                 

Purpose

Allergy symptom reliever

Uses

Temporarily relieves these symptoms of hey fever or other respiratory allergies:

Warnings

For external use only

Do not use

  • In children under 2 years of age
  • If you have ever had an allergic reaction to any of the ingredients

Ask a doctor before use if you

  • have had recent nose ulcers or nose surgery
  • have had a nose injury that has not healed
  • are using a steroid medicine for asthma, allergies or skin rash
  • have an eye infection
  • have or had glaucoma or cataracts

When using this product

  • the growth rate of some children may be slower
  • some symptoms may get better on the first day of treatment. It may take up to one week of daily use to feel the most symptom relief.
  • do not share this bottle with anyone else as this may spread germs
  • remember to tell your doctor about all the medicines you take, including this one

Stop use and ask a doctor if

  • you have, or come in contact with someone who has, chickenpox, measles or tuberculosis
  • you have or develop symptoms of an infection such as persist fever
  • you have any change in vision
  • you have severe or frequent nosebleeds

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Read insert (inside package) on how to:

Other information

Inactive ingredients

benzalkonium chloride solution (50% W/V) dextrose monohydrate, edetate disodium dihydrate, hydrochloric acid, microcrystalline cellulose, polysorbate 80 purified water & sodium hydroxide  

Questions or comments?

Call toll-free1-800-706-5575

Principal Display Panel

Triamcinolone Acetonide Nasal Spray, USP

55 mcg per spray

allergy symptom reliever(glucocorticoid)

120 MD per spray

NDC 60505-6275-7

120MD-bottle-label

120MD-CTN-label

TRIAMCINOLONE ACETONIDE 
triamcinolone acetonide spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-6275
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (Triamcinolone Acetonide - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE55 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-6275-71 in 1 CARTON01/26/2024
1120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21461501/26/2024
Labeler - Apotex Corp. (845263701)

Revised: 4/2024
Document Id: 3c8b26cd-155e-4817-efc8-ecb8528a5eb7
Set id: a0cde3d7-4934-ed19-78c0-01f21275cba0
Version: 4
Effective Time: 20240408
 
Apotex Corp.