Triamcinolone acetonide

Manufacturer
RUGBY LABORATORIES, INC.
Effective date
2025-09-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:34:29

Label at a glance#

ProductTriamcinolone acetonide
Active ingredientTRIAMCINOLONE ACETONIDE
Label structure10 sections

Indications and uses

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

Dosage and administration

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. C...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Triamcinolone acetonide 55 mcg (glucocorticoid)

                                 

Purpose

OTC - PURPOSE SECTION

Allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 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

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: DO NOT USE IF SEALS ON CARTON ARE BROKEN OR MISSING
  • keep package and insert, They contain important information.
  • Store between 20ºC to 25ºC (68ºF to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free1-800-706-5575

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triamcinolone Acetonide Nasal Spray, USP

55 mcg per spray

allergy symptom reliever(glucocorticoid)

120 MD per spray

NDC 00536-1441-69

120MD-bottle-label120MD-bottle-label

120MD-CTN-label120MD-CTN-label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-14410536-1441-69

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c70f1b46-d4ee-0a98-107a-0ee0c0d08f830c180caf-1298-e66c-023c-3f648eb924512026-05-26WarningsExact identifier
spl set id: 0c180caf-1298-e66c-023c-3f648eb92451

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.