CHILDRENS TRIAMCINOLONE ACETONIDE

CHILDRENS TRIAMCINOLONE ACETONIDE is an FDA-registered drug product whose active ingredient is TRIAMCINOLONE ACETONIDE. It is labelled by Aurohealth LLC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 58602-037, application ANDA220110, label effective 20260813. It is one of 91 FDA drug label records sharing the active ingredient TRIAMCINOLONE ACETONIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TRIAMCINOLONE ACETONIDE are most often described in connection with: temporarily relieves, symptoms hay, upper respiratory, allergies nasal, congestion runny, nose sneezing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Children's Triamcinolone 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 fig-1 fig-2 figure fig-4 Figure F Figure G

Other information do not use if sealed package is torn or opened keep package and insert. They contain important information. store between 20° to 25°C (68° to 77°F)

FDA lists 91 drug label records with TRIAMCINOLONE ACETONIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is CHILDRENS TRIAMCINOLONE ACETONIDE used for?
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

Who makes CHILDRENS TRIAMCINOLONE ACETONIDE?
Aurohealth LLC is the labeler of record for CHILDRENS TRIAMCINOLONE ACETONIDE. 91 FDA label records share the active ingredient TRIAMCINOLONE ACETONIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does CHILDRENS TRIAMCINOLONE ACETONIDE come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is CHILDRENS TRIAMCINOLONE ACETONIDE prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TRIAMCINOLONE ACETONIDE?
Yes. 91 FDA drug label records list TRIAMCINOLONE ACETONIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has CHILDRENS TRIAMCINOLONE ACETONIDE been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.