drug facts

drug facts
SPL v5
SPL
SPL Set ID a0cde3d7-4934-ed19-78c0-01f21275cba0
Route
nasal
Published
Effective Date 2023-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
triamcinolone acetonide (55 ug)
Inactive Ingredients
benzalkonium chloride dextrose monohydrate edetate disodium hydrochloric acid sodium hydroxide water microcrystalline cellulose polysorbate 80 carboxymethylcellulose sodium, unspecified

Identifiers & Packaging

Marketing Status
anda active Since 2024-01-26

Purpose

Allergy symptom reliever

Description

Triamcinolone acetonide 55 mcg (glucocorticoid)                                  


Medication Information

Warnings

For external use only

Uses

Temporarily relieves these symptoms of hey fever or other 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
    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
Other Information

  • TAMPER EVIDENT: DO NOT USE IF SEALS ON CARTON ARE BROKEN OR MISSING
  • Store between 20ºC to 25ºC (68ºF to 77ºF)
Inactive Ingredients

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

Description

Triamcinolone acetonide 55 mcg (glucocorticoid)                                  

Principal Display Panel

Triamcinolone Acetonide Nasal Spray, USP

55 mcg per spray

allergy symptom reliever (glucocorticoid)

120 MD per spray

NDC 60505-6275-7

Do Not Use

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

Triamcinolone acetonide 55 mcg (glucocorticoid)

                                 

Questions Or Comments?

Call toll-free 1-800-706-5575

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.

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

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves these symptoms of hey fever or other 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
    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
Other Information (Other information)

  • TAMPER EVIDENT: DO NOT USE IF SEALS ON CARTON ARE BROKEN OR MISSING
  • Store between 20ºC to 25ºC (68ºF to 77ºF)
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Triamcinolone Acetonide Nasal Spray, USP

55 mcg per spray

allergy symptom reliever (glucocorticoid)

120 MD per spray

NDC 60505-6275-7

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
Active Ingredient (Active ingredient)

Triamcinolone acetonide 55 mcg (glucocorticoid)

                                 

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-706-5575

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 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 (If pregnant or breast-feeding)

ask a health professional before use.

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

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 right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)