FDA.reportPublic FDA data

Signature Care Nasal Allergy Spray Drug Facts

Manufacturer
Sixarp, LLC
Effective date
2025-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:38

Label at a glance#

ProductSignature Care Nasal Allergy
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 CH...

Storage and handling

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

Label contents#

Full prescribing information#

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

OTC - ASK DOCTOR 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 - WHEN USING 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 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 breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 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 notdouble 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

STORAGE AND HANDLING SECTION

  • do not use if printed bottle wrap is torn or opened
  • keep package and insert. They contain important information.
  • store between 20 °-25 °C (68 °-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), microcrystalline cellulose, polysorbate 80, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Consumer information

SPL UNCLASSIFIED SECTION

Triamcinolone Acetonide Nasal Spray 55 mcg per spray

IMPORTANT INFORMATION

  • Read both sides of this insertfor 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.

  1. Remove cap and safety clip (Figure A).
  2. Shake bottle.
  3. 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.
Figure A
Figure A

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).
Figure B
Figure B

DO NOTspray toward nasal septum (the wall between the 2 nostrils) (as shown in Figure D).

Figures C & D
Figures C & D
  1. 6. While sniffing gently, spray into nostril.

IMPORTANT: For complete dosing instructions, See “Directions for use” on next side.

  1. 7. Repeat steps “4” through “6” for the other nostril.
  2. 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 notdouble 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.
Figure E
Figure E

CLEANING INSTRUCTIONS

  1. Gently pull spray nozzle away from bottle (as shown in Figure F).
  2. Rinse SPRAY NOZZLE ONLYunder 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.
Figure F
Figure F

Figure GFigure G

Triamcinolone Acetonide Nasal Spraypump is now ready to use.

Where can I get more information? 1-800-719-9260

Store between 20°-25°C (68°-77°F)

Made in Israel

Distributed By

Perrigo®

Allegan, MI 49010

SIDE 2

: 44300 00 J4

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Nasacort ®Allergy 24HR active ingredient

Quality Guaranteed

ORIGINAL PRESCRIPTION STRENGTH

MULTI-SYMPTOM

Nasal Allergy Spray

Triamcinolone Acetonide Nasal Spray, 55mcg per spray

Allergy Symptom Reliever (Glucocorticoid)*

Non-Drowsy

24 HR Relief of:

Nasal Congestion

Sneezing

Runny Nose

Itchy Nose

*Triamcinolone acetonide is a steroid medicine known as a glucocorticoid.

24 HOUR

0.37 FL OZ (10.8mL)

60 SPRAYS

Alcohol-free

Scent-free

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-20359368-203-01, 59368-203-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
TRIAMCINOLONE ACETONIDEF446C597KAACTIB

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
3d32cd4f-9552-a5d9-e063-6294a90ad8c02e0c02ae-0b64-0dda-e063-6394a90ab33c2025-08-25WarningsExact identifier
spl id: 3d32cd4f-9552-a5d9-e063-6294a90ad8c0
spl set id: 2e0c02ae-0b64-0dda-e063-6394a90ab33c

Reported adverse events (FAERS/openFDA)#

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