Drug Facts

Manufacturer: Sam's West Inc. | Apotex Inc.
Effective date: 2026-09-21
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: daily-update
Hydrated at: 2026-09-24 01:01:03

Label at a glance#

ProductFluticasone Propionate

Active ingredientFLUTICASONE PROPIONATE

Label structure11 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 - a...

Contacts and useful links#

PhoneLabel contact1-800-706-5575

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

Principal Display Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Aller-Nose Nasal Spray

Fluticasone Propionate Nasal Spray, USP

Apotex Corp. NDC 68196-210-01

6 bottles (144 sprays each)

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

Itchy, Watery Eyes
Nasal Congestion
Runny Nose
Itchy Nose
Sneezing

Carton-label

Principal Display Panel - Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Aller-Nose Nasal Spray

Fluticasone Propionate Nasal Spray, USP

Apotex Corp. NDC 68196-210-02

144 sprays 0.62 fl oz (18.2 mL)

Allergy Symptom Reliever Nasal Spray

Bottle-label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

Products#

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

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

Fluticasone Propionate
Fluticasone
BENZALKONIUM CHLORIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
DEXTROSE, UNSPECIFIED FORM
PHENYLETHYL ALCOHOL
POLYSORBATE 80
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68196-210	68196-210-02, 68196-210-01

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
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#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2025-09-22	full-release	2026-06-01 01:14:22

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-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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
836cdab1-65ae-a9f6-27d4-b1f966b68022			0370ef12-9199-e2ef-ef85-7d2c7d413bc9	2025-09-22	Warnings	Exact identifier spl set id: 0370ef12-9199-e2ef-ef85-7d2c7d413bc9

Reported adverse events (FAERS/openFDA)#

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