Fluticasone propionate

Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2022-03-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:06:48

Label at a glance#

ProductFluticasone propionate
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 mont...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid) 50 mcg (in each spray)

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

SPL UNCLASSIFIED SECTION

have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

Pregnancy 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.

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 once daily

CHILDREN UNDER 4 YEARS OF AGE

■ do not use

Other information

SPL UNCLASSIFIED SECTION

■ TAMPER EVIDENT: Do not use if plastic sleeve is torn or broken. Under the cap and nozzle, each

bottle has an aluminum seal around bottle neck. Do not use if any of these features are torn or

damaged.

■ you may start to feel relief the first day and full effect after several days of regular, once-a-day use

■ store between 4° and 30°C (39° and 86°F)

■ keep the label and enclosed materials. They contain important additional information.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments

SPL UNCLASSIFIED SECTION

Call toll-free 1-800-262-9010 weekdays (9:00 am- 5:00 pm)

What problems can Fluticasone Propionate Nasal Spray help with?

SPL UNCLASSIFIED SECTION

Fluticasone Propionate Nasal Spray helps relieve a broad range of uncomfortable symptoms like congestion, runny nose, sneezing, itchy nose and itchy eyes.

These symptoms can be triggered by allergens like pollen, mold, dust and pet dander.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev.968:00 09/17

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

AKORN

* Compare to the active ingredient in Flonase®

NDC 50383-968-16

Fluticasone Propionate Nasal Spray (Glucocorticoid), 50 mcg Per Spray

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

■ Itchy, Watery Eyes

■ Nasal Congestion

■ Runny Nose

■ Itchy Nose

■ Sneezing

NEW: FULL PRESCRIPTION STRENGTH

NON DROWSY

24 HOUR RELIEF

120 METERED SPRAYS

0.54 fl oz (15.8 mL)

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-968FLUTICASONE PROPIONATE SPRAY, METERED [AKORN]9Legacy NDC20220309_a778d891-b9e9-47d7-b474-4baca8be1dbd.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50383-96850383-968-18, 50383-968-16, 50383-968-36, 50383-968-37, 50383-968-38

Ingredients#

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

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

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208024-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1784e616aacf4f…
2026-08-18 06:07:402026-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17f41ea6bd6efb…

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
919f6e8e-a928-45d1-ae78-d0984a941d4fa778d891-b9e9-47d7-b474-4baca8be1dbd2025-09-10WarningsExact identifier
spl set id: a778d891-b9e9-47d7-b474-4baca8be1dbd

Reported adverse events (FAERS/openFDA)#

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