Triamcinolone acetonide — v5

Triamcinolone acetonide

7 Views

Version

v5

Effective date

September 22, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
7e36fea9-1c98-560a-104a-c83528f30b5b
Set ID
a0cde3d7-4934-ed19-78c0-01f21275cba0
Application numbers
ANDA214615
Product NDCs
60505-6275
Package NDCs
60505-6275-7
Original packager NDCs

Names & Manufacturers

Brand names
Triamcinolone acetonide
Generic names
TRIAMCINOLONE ACETONIDE
Manufacturer names
Apotex Corp.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
TRIAMCINOLONE ACETONIDE
Routes
NASAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Corticosteroid [EPC]
Pharmacologic class (CS)
Mechanism of action
Corticosteroid Hormone Receptor Agonists [MoA]

Other identifiers

NUI
N0000175450, N0000175576
RxCUI
1797913
UNII
F446C597KA
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each spray) Triamcinolone acetonide 55 mcg (glucocorticoid)
Ask Doctor (1)

Sequence 1

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
Do Not Use (1)

Sequence 1

Do not use In children under 2 years of age If you have ever had an allergic reaction to any of the ingredients
Dosage And Administration (1)

Sequence 1

Directions Read insert (inside package) on how to: get a new bottle ready (primed) before first use prime bottle again if not used for more than 2 weeks use the spray clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older once daily, spray 2 times into each nostril while sniffing gently once your allergy symptoms improve, reduce to 1 spray in each nostril CHILDREN 2 TO UNDER 12 YEARS OF AGE the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray longer than two months a year. children 6 to under 12 years of age an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day. children 2 to under 6 years of age an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age do not use do not use more than directed if you forget a dose, do not double the next dose do not spray into eyes or mouth if allergy symptoms do not improve after one week, stop using and talk to a doctor do not use for the common cold shake well before each use
Dosage And Administration Table (1)

Sequence 1

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
adults and children 12 years of age and olderonce daily, spray 2 times into each nostril while sniffing gently
once your allergy symptoms improve, reduce to 1 spray in each nostril
CHILDREN 2 TO UNDER 12 YEARS OF AGE
the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray longer than two months a year.
children 6 to under 12 years of agean adult should supervise use
once daily, spray 1 time into each nostril while sniffing gently
if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.
children 2 to under 6 years of agean adult should supervise use
once daily, spray 1 time into each nostril while sniffing gently
children under 2 years of agedo not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients benzalkonium chloride solution (50% W/V) dextrose monohydrate, edetate disodium dihydrate, hydrochloric acid, microcrystalline cellulose, polysorbate 80 purified water & sodium hydroxide
Indications And Usage (1)

Sequence 1

Uses Temporarily relieves these symptoms of hey fever or other respiratory allergies: nasal congestion runny nose sneezing itchy nose
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel Triamcinolone Acetonide Nasal Spray, USP 55 mcg per spray allergy symptom reliever (glucocorticoid) 120 MD per spray NDC 60505-6275-7
Purpose (1)

Sequence 1

Purpose Allergy symptom reliever
Questions (1)

Sequence 1

Questions or comments? Call toll-free 1-800-706-5575
Spl Product Data Elements (1)

Sequence 1

Triamcinolone acetonide Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide BENZALKONIUM CHLORIDE DEXTROSE MONOHYDRATE EDETATE DISODIUM HYDROCHLORIC ACID SODIUM HYDROXIDE WATER MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED 120MD-bottle-label 120MD-CTN-label
Spl Unclassified Section (1)

Sequence 1

Other information TAMPER EVIDENT: DO NOT USE IF SEALS ON CARTON ARE BROKEN OR MISSING Store between 20ºC to 25ºC (68ºF to 77ºF)
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['ANDA214615'],
 'brand_name': ['Triamcinolone acetonide'],
 'generic_name': ['TRIAMCINOLONE ACETONIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Apotex Corp.'],
 'nui': ['N0000175576', 'N0000175450'],
 'package_ndc': ['60505-6275-7'],
 'pharm_class_epc': ['Corticosteroid [EPC]'],
 'pharm_class_moa': ['Corticosteroid Hormone Receptor Agonists [MoA]'],
 'product_ndc': ['60505-6275'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['NASAL'],
 'rxcui': ['1797913'],
 'spl_id': ['7e36fea9-1c98-560a-104a-c83528f30b5b'],
 'spl_set_id': ['a0cde3d7-4934-ed19-78c0-01f21275cba0'],
 'substance_name': ['TRIAMCINOLONE ACETONIDE'],
 'unii': ['F446C597KA']}