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
FLONASE
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2022-07-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:57:10
Label at a glance#
ProductFLONASE ALLERGY RELIEF
Active ingredientFLUTICASONE PROPIONATE
Label structure9 sections
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 – ask ...
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° and 30°C (39° and 86°F) keep this label and enclosed materials. They contain important additional information.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each spray)
Fluticasone propionate (glucocorticold) 50 mcg
Purpose
Allergy symptom reliever
Uses
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- sneezing
- itchy nose
- itchy, watery eyes
Warnings
Only for use in the nose. Do not spray into your eyes or mouth.
Do not use
- 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
have or had glaucoma or cataracts
Ask a doctor or pharmacist before use if you are taking
- 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
- 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
- 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,
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 right away.
Directions
- 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
- 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 this label and enclosed materials. They contain important additional information.
Inactive ingredients
benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethylalcohol, polysorbate 80, purified water, sodium carboxymethylcellulose
Questions or comments?
call toll-free 1-844-FLONASE (1-844-356-6273) (English/Spanish) weekdays
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: FLONASEALLERGY RELIEF ALLERGY RELIEF
GENERIC: fluticasone propionate
DOSAGE: SPRAY, METERED
ADMINSTRATION: NASAL
NDC: 70518-1223-0
NDC: 70518-1223-1
PACKAGING: 120 in 1 BOTTLE, TYPE 2
OUTER PACKAGING: 1 in 1 PACKAGE
OUTER PACKAGING: 1 in 1 PACKAGE
PAKCAGING: 144 in 1 BOTTLE, TYPE 2
ACTIVE INGREDIENT(S):
- FLUTICASONE PROPIONATE 50ug in 1
INACTIVE INGREDIENT(S):
- BENZALKONIUM CHLORIDE
- DEXTROSE, UNSPECIFIED FORM
- MICROCRYSTALLINE CELLULOSE
- PHENYLETHYL ALCOHOL
- POLYSORBATE 80
- WATER
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0576-02 | ML - Milliliter | 0135-0576 | 530d5343-ecd6-4d4c-8c91-009427e86b7d | 1 | 2015-02-02 |
| 0135-0576-03 | ML - Milliliter | 0135-0576 | 865c93a8-8bed-4d15-9ec7-6d112b4d31e7 | 1 | 2015-02-02 |
| 0135-0576-04 | ML - Milliliter | 0135-0576 | d0a68cc5-b3ef-40cb-98e4-287b6f5a3b0f | 1 | 2015-02-02 |
| 0135-0576-14 | ML - Milliliter | 0135-0576 | dd0b22db-120a-4750-9412-a0b7f66f9ffb | 1 | 2018-08-13 |
| 0135-0576-15 | ML - Milliliter | 0135-0576 | 5048df9c-fbbf-4899-880b-a2954d70f8bf | 1 | 2018-03-08 |
| 0135-0576-16 | ML - Milliliter | 0135-0576 | f5dd4265-38d2-4dc4-9d1c-e8e9a95a69df | 1 | 2018-03-08 |
| 0135-0576-17 | ML - Milliliter | 0135-0576 | cc1b971f-e7c4-4473-adcd-85d87f59cef7 | 1 | 2020-04-20 |
| 0135-0576-18 | ML - Milliliter | 0135-0576 | 2b27c673-6c75-4a9c-babe-637772aafa20 | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- FLONASE ALLERGY RELIEF
- fluticasone propionate
- BENZALKONIUM CHLORIDE
- DEXTROSE, UNSPECIFIED FORM
- MICROCRYSTALLINE CELLULOSE
- PHENYLETHYL ALCOHOL
- POLYSORBATE 80
- WATER
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- FLUTICASONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-1223 | 70518-1223-0, 70518-1223-1 |
| 0135-0576 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| PHENYLETHYL ALCOHOL | ML9LGA7468 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| FLUTICASONE PROPIONATE | O2GMZ0LF5W | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205434-001 | FLONASE ALLERGY RELIEF | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2014-07-23 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N205434-001 | FLONASE ALLERGY RELIEF | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2014-07-23 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FLONASE ALLERGY RELIEF | FLUTICASONE PROPIONATE | Haleon US Holdings LLC | b6134ba0-b70a-4eac-9a82-cef64b242c1d | 2024-12-19 | Warnings | 0135-0576 |
| e4a67239-4484-4a30-e053-2a95a90a955c | b9c49adf-63fe-4d44-b296-d91da418d0b3 | 2022-07-25 | Warnings | b9c49adf-63fe-4d44-b296-d91da418d0b3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.