482 - Nasal Spray Triamcinolone Acetonide

482 - Nasal Spray Triamcinolone Acetonide
SPL v2
SPL
SPL Set ID 1fd76a49-61ee-4d4d-8abc-e666b2d3c5b0
Route
NASAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triamcinolone Acetonide (55 ug)
Inactive Ingredients
Benzalkonium Chloride Carboxymethylcellulose Sodium Dextrose Monohydrate Edetate Disodium Anhydrous Hydrochloric Acid Microcrystalline Cellulose Polysorbate 80 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-07-30

Description

Triamcinolone acetonide 55 mcg (glucocorticoid)

Purpose

Allergy symptom reliever


Medication Information

Purpose

Allergy symptom reliever

Description

Triamcinolone acetonide 55 mcg (glucocorticoid)

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose
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 per day

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 for 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 the 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
Do Not Use
  • in children under 2 years of age
  • if you have ever had an allergic reaction to any of the ingredients
Other Information
  • TAMPER EVIDENT: DO NOT USE IF SEALS ON CARTON ARE BROKEN OR MISSING
  • keep package and insert. They contain important information.
  • store between 20°C to 25°C (68°F to 77°F)
Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Triamcinolone acetonide 55 mcg (glucocorticoid)

Inactive Ingredients

benzalkonium chloride solution (50% W/V), carboxymethylcellulose sodium, dextrose monohydrate,

edetate disodium dihydrate, hydrochloric acid, microcrystalline cellulose, polysorbate 80, purified

water & sodium hydroxide

Principal Display Panel

Triamcinolone acetonide Carton
Triamcinolone acetonide Insert

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 into contact with someone who has, chickenpox, measles or tuberculosis
  • you have or develop symptoms of an infection such as a persistent fever
  • you have any change in vision
  • you have severe or frequent nosebleeds
If Pregnant Or Breastfeeding,

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 (1-800-222-1222) right away.

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

Structured Label Content

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose
Purpose

Allergy symptom reliever

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 per day

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 for 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 the 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
Do Not Use (Do not use)
  • in children under 2 years of age
  • if you have ever had an allergic reaction to any of the ingredients
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF SEALS ON CARTON ARE BROKEN OR MISSING
  • keep package and insert. They contain important information.
  • store between 20°C to 25°C (68°F to 77°F)
Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Triamcinolone acetonide 55 mcg (glucocorticoid)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution (50% W/V), carboxymethylcellulose sodium, dextrose monohydrate,

edetate disodium dihydrate, hydrochloric acid, microcrystalline cellulose, polysorbate 80, purified

water & sodium hydroxide

Principal Display Panel

Triamcinolone acetonide Carton
Triamcinolone acetonide Insert

When Using This Product (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 (Stop use and ask a doctor if)
  • you have, or come into contact with someone who has, chickenpox, measles or tuberculosis
  • you have or develop symptoms of an infection such as a persistent fever
  • you have any change in vision
  • you have severe or frequent nosebleeds
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)