On this page
Triamcinolone acetonide
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Corticosteroid Hormone Receptor Agonists [MoA] | MoA | All 215 members |
| Corticosteroid [EPC] | EPC | All 215 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 214615-001 | TRIAMCINOLONE ACETONIDE | SPRAY, METERED | TRIAMCINOLONE ACETONIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | January 19, 2023 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260813). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Purpose
openFDA Drug LabelingPurpose Allergy symptom reliever
Dosage and Administration
openFDA Drug LabelingTriamcinolone Acetonide Nasal Spray, USP 55 mcg per spray IMPORTANT INFORMATION Read both sides of this insert for complete instructions on how to get a bottle ready (primed), how to use the spray bottle and how to clean the spray nozzle. Keep this insert as it contains important information. STEPS TO GET A NEW BOTTLE READY FOR USE (PRIMED) 1. Before first use, a new bottle must be primed. a. Remove cap and safety clip (Figure A). b. Shake bottle. c. Press and release spray nozzle until a fine mist is produced (as shown in Figure B). This may take several times. Take care not to spray in face. PRIME BOTTLE AGAIN IF NOT USED FOR MORE THAN 2 WEEKS Repeat steps for priming a bottle (see above). USE INSTRUCTIONS 1. Blow nose gently to clear nostrils. 2. Remove cap and safety clip, then shake bottle. 3. Hold bottle with thumb under bottle and spray nozzle between fingers (as shown in Figure B). 4. Press against the outside of your nose with your finger to close off one nostril (as shown in Figure C) . 5. Place the tip of the spray nozzle into the other nostril. The spray nozzle should not reach far into the nose. Aim nozzle toward back of nose (as shown in Figure C) . DO NOT spray toward nasal septum (the wall between the 2 nostrils) (as shown in Figure D) . 6. While sniffing gently, spray into nostril. IMPORTANT: For complete dosing instructions, See “Directions for use” on next side. 7. Repeat steps “4” through “6” for the other nostril. 8. After using the nasal spray, wipe nozzle with a tissue, replace safety clip, and replace cap by pressing it down over the spray nozzle. NOTE: Avoid blowing nose for 15 minutes after use. If nozzle does not spray properly, see cleaning instructions on next side. (continued on side 2) SIDE 1 DIRECTIONS FOR USE BEFORE first use, you must get a new bottle ready (primed). If bottle is not used for more than 2 weeks, prime bottle again. Dosing 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 Other important information for 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 you get the spray in your eyes, rinse well with water. If allergy symptoms do not improve after one week, stop using and talk to a doctor. Do not share this bottle with anyone else as this may spread germs. IF PUMP DOES NOT SPRAY PROPERLY, THE NOZZLE MAY BE BLOCKED 1. Never try to unblock nozzle with a pin or any other object (as shown in Figure E) . 2. Clean the nozzle as shown below. CLEANING INSTRUCTIONS 1. Gently pull spray nozzle away from bottle (as shown in Figure F) . 2. Rinse SPRAY NOZZLE ONLY under warm water (as shown in Figure G) . 3. Shake or tap to remove excess water. 4. Re-attach spray nozzle to bottle. 5. Press and release spray nozzle until a fine spray is produced, taking care not to spray in face. Triamcinolone Acetonide Nasal Spray, USP pump is now ready to use. Where can I get more information? 1-855-274-4122 Store between 20° to 25°C (68° to 77°F) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016 Issued: 05/2025 SIDE 2 Figure A fig …
Warnings
openFDA Drug LabelingWarnings 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 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.
Do Not Use
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingWhen 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
openFDA Drug LabelingDirections 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 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
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each spray) Triamcinolone acetonide USP 55 mcg (glucocorticoid)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TRIAMCINOLONE ACETONIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69168-482-01 | 69168-482 | Allegiant Health | 1 BOTTLE in 1 CARTON (69168-482-01) / 120 SPRAY, METERED in 1 BOTTLE | July 30, 2025 |
| 60505-6275-7 | 60505-6275 | Apotex Corp. | 1 BOTTLE, SPRAY in 1 CARTON (60505-6275-7) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | January 26, 2024 |
| 58602-035-07 | 58602-035 | Aurohealth LLC | 1 BOTTLE, SPRAY in 1 CARTON (58602-035-07) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | August 11, 2026 |
| 58602-035-08 | 58602-035 | Aurohealth LLC | 2 BOTTLE, SPRAY in 1 CARTON (58602-035-08) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | August 11, 2026 |
| 58602-035-09 | 58602-035 | Aurohealth LLC | 3 BOTTLE, SPRAY in 1 CARTON (58602-035-09) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | August 11, 2026 |
| 58602-035-10 | 58602-035 | Aurohealth LLC | 1 BOTTLE, SPRAY in 1 CARTON (58602-035-10) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | August 11, 2026 |
| 12516-1508-0 | 12516-1508 | Bespak HC Limited | 189 BOTTLE, SPRAY in 1 CARTON (12516-1508-0) / 16.5 g in 1 BOTTLE, SPRAY | October 11, 2013 |
| 12516-1509-0 | 12516-1509 | Bespak HC Limited | 189 BOTTLE, SPRAY in 1 CARTON (12516-1509-0) / 10.5 g in 1 BOTTLE, SPRAY | October 11, 2013 |
| 12516-1510-0 | 12516-1510 | Bespak HC Limited | 189 BOTTLE, SPRAY in 1 CARTON (12516-1510-0) / 6.5 g in 1 BOTTLE, SPRAY | September 7, 2017 |
| 70000-0742-1 | 70000-0742 | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 1 BOTTLE, SPRAY in 1 CARTON (70000-0742-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | November 26, 2025 |
| 67438-045-00 | 67438-045 | Padagis Israel Pharmaceuticals Ltd | 120 SPRAY, METERED in 1 BOTTLE (67438-045-00) | June 19, 2015 |
| 67438-045-01 | 67438-045 | Padagis Israel Pharmaceuticals Ltd | 60 SPRAY, METERED in 1 BOTTLE (67438-045-01) | October 12, 2016 |
| 67438-045-02 | 67438-045 | Padagis Israel Pharmaceuticals Ltd | 72 SPRAY, METERED in 1 BOTTLE (67438-045-02) | February 28, 2021 |
| 67438-045-03 | 67438-045 | Padagis Israel Pharmaceuticals Ltd | 144 SPRAY, METERED in 1 BOTTLE (67438-045-03) | February 28, 2021 |
| 69168-482 | 69168-482 | Allegiant Health | — | July 30, 2025 |
| 60505-6275 | 60505-6275 | Apotex Corp. | — | January 26, 2024 |
| 58602-035 | 58602-035 | Aurohealth LLC | — | August 11, 2026 |
| 12516-1508 | 12516-1508 | Bespak HC Limited | — | October 11, 2013 |
| 12516-1509 | 12516-1509 | Bespak HC Limited | — | October 11, 2013 |
| 12516-1510 | 12516-1510 | Bespak HC Limited | — | September 7, 2017 |
| 70000-0742 | 70000-0742 | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | — | November 26, 2025 |
| 67438-045 | 67438-045 | Padagis Israel Pharmaceuticals Ltd | — | June 19, 2015 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.