Indications and uses
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose
Fluticasone Propionate
- Manufacturer
- Walmart | Apotex Inc.
- Effective date
- 2020-09-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:14:01
Label at a glance#
ProductFluticasone Propionate
Active ingredientFLUTICASONE PROPIONATE
Label structure11 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 - a...
Contacts and useful links#
Label contents#
Full prescribing information#
SPL PRODUCT DATA ELEMENTS SECTION
SPL UNCLASSIFIED SECTION
Active ingredient (in each spray)
Fluticasone propionate (glucocorticoid) 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
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
OTC - ASK DOCTOR SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 at 4° to 30°C (39° to 86°F)
- keep this label and enclosed materials. They contain important additional information.
Inactive ingredients
0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water
Questions or comments?
1-888-287-1915
Principal Display Panel - Carton (60md)
CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray
Walmart NDC 49035-060-01
Fluticasone Propionate Nasal Spray, USP
60 sprays
Allergy Symptom Reliever Nasal Spray
24 Hour Relief of:
- Nasal Congestion
- Runny Nose
- Itchy Nose
- Sneezing
Principal Display Panel - Bottle (60md)
BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray
Walmart NDC 49035-060-01
Fluticasone Propionate Nasal Spray, USP
60 sprays
Allergy Symptom Reliever Nasal Spray
Products#
Every source-derived product name is available through these pages.
- Fluticasone Propionate
- Fluticasone
- BENZALKONIUM CHLORIDE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- DEXTROSE, UNSPECIFIED FORM
- PHENYLETHYL ALCOHOL
- POLYSORBATE 80
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49035-060 | 49035-060-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FLUTICASONE PROPIONATE | O2GMZ0LF5W | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | IACT |
| PHENYLETHYL ALCOHOL | ML9LGA7468 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A208150-001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 |
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 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208150-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-02-29 | 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 |
|---|---|---|---|---|---|---|
| 2457fda2-fcae-75c7-c1aa-495680e67ef1 | 155b225b-e26d-2fcd-eee2-3e12384682e0 | 2020-09-25 | Warnings | 2457fda2-fcae-75c7-c1aa-495680e67ef1 155b225b-e26d-2fcd-eee2-3e12384682e0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.