Drug Facts
Active ingredient (in each spray)
Triamcinolone acetonide USP 55 mcg (glucocorticoid)
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Childrens Triamcinolone Acetonide (NDC 58602-037). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each spray)
Triamcinolone acetonide USP 55 mcg (glucocorticoid)
Allergy symptom reliever
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
Do not use
If pregnant or breast-feeding, 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.
Read insert (inside package) on how to:
| ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER | |
| adults and children 12 years of age and older |
|
| CHILDREN 2 TO UNDER 12 YEARS OF AGE | |
| |
| children 6 to under 12 years of age |
|
| children 2 to under 6 years of age |
|
| children under 2 years of age |
|
| |
benzalkonium chloride, dextrose (anhydrous), edetate disodium, hydrochloric acid (for pH adjustment), microcrystalline cellulose and carboxymethyl cellulose sodium, polysorbate 80, purified water and sodium hydroxide (for pH adjustment).
call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: AP/DRUGS/04/2016
Triamcinolone Acetonide Nasal Spray, USP
55 mcg per spray
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
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
| |
| Dosing | |
| ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER | |
| adults and children 12 years of age and older |
|
| CHILDREN 2 TO UNDER 12 YEARS OF AGE | |
| |
| children 6 to under 12 years of age |
|
| children 2 to under 6 years of age |
|
| children under 2 years of age |
|
| Other important information for use | |
| |
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
AUROHEALTH
NDC 58602-037-11
**Compare to the active ingredient of Children's
Nasacort®Allergy 24 HR
CHILDREN'S
age
2+
Triamcinolone Acetonide
Nasal Spray, USP
55 mcg per spray
Allergy Symptom Reliever
(glucocorticoid)*
NON-DROWSY
MULTI-SYMPTOM
24 HOUR RELIEF
• NASAL CONGESTION
• SNEEZING
• RUNNY NOSE
• ITCHY NOSE
SCENT-FREE
ALCOHOL-FREE
60
SPRAYS
0.37 fl. oz. (10.8 mL)
ORIGINAL PRESCRIPTION STRENGTH
*Triamcinolone acetonide is a steroid
medicine known as a glucocorticoid.
* Please review the disclaimer below.