FDA.reportPublic FDA data

Fluticasone Propionate Nasal

Manufacturer
Praxis, LLC
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:10

Label at a glance#

ProductFluticasone Propionate Nasal
Active ingredientFLUTICASONE PROPIONATE
Label structure9 sections

Indications and uses

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

Dosage and administration

read the Quick Start Guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1 – use 2 sprays in each nostril once daily Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms After 6 months of daily use – as...

Storage and handling

you may start to feel relief the first day and full effect after several days of regular, once-a-day use store between 4 o and 30 o C (39 o and 86 o F) keep this package and enclosed materials. They contain important additional information.

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid) 50 mcg

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
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Only for use in the nose. Do not spray into your eyes or mouth.

Do not use

OTC - DO NOT USE SECTION

  • in children under 4 years of age
  • to treat asthma
  • if you have an injury or surgery to your nose that is not fully healed
  • if you have ever had an allergic reaction to this product or any of the ingredients

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • medicine for HIV infection (such as ritonavir)
  • a steroid medicine for asthma, allergies or skin rash
  • ketoconazole pills (medicine for fungal infection)

When using this product

OTC - WHEN USING SECTION

  • the growth rate of some children may be slower
  • stinging or sneezing may occur for a few seconds right after use
  • 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, chicken pox, measles or tuberculosis
  • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
  • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.
  • you get an allergic reaction to this product. Seek medical help right away.
  • you get new changes to your vision that develop after starting this product
  • 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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • read the Quick Start Guide for how to:
  • prime the bottle
  • use the spray
  • clean the spray nozzle
  • shake gently before each use
  • use this product only once a day
  • do not use more than directed

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

  • Week 1 – use 2 sprays in each nostril once daily
  • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms
  • After 6 months of daily use – ask your doctor if you can keep using

CHILDREN 4 TO 11 YEARS OF AGE

  • The growth rate of some children may be slower while using this product.

    Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.

  • an adult should supervise use
  • use 1 spray in each nostril daily

CHILDREN UNDER 4 YEARS OF AGE

  • do not use

Other information

STORAGE AND HANDLING SECTION

  • you may start to feel relief the first day and full effect after several days of regular, once-a-day use
  • store between 4 oand 30 oC (39 oand 86 oF)
  • keep this package and enclosed materials. They contain important additional information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-342FLUTICASONE PROPIONATE NASAL (FLUTICASONE PROPIONATE) SPRAY, METERED [PRAXIS, LLC]1Unmatched20250330_315979ab-1b06-ebad-e063-6294a90ac19a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-34259368-342-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
FLUTICASONE PROPIONATEO2GMZ0LF5WACTIB

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
315979a8-b0fe-68a3-e063-6394a90a13f1315979ab-1b06-ebad-e063-6294a90ac19a2023-01-01WarningsExact identifier
spl id: 315979a8-b0fe-68a3-e063-6394a90a13f1
spl set id: 315979ab-1b06-ebad-e063-6294a90ac19a

Reported adverse events (FAERS/openFDA)#

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