Fluticasone Propionate — v9

Fluticasone Propionate

9 Views

Version

v9

Effective date

September 23, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
86c50531-67d1-433d-f3ad-37be44686552
Set ID
43ac5199-cf46-29a6-b096-d96ee944bf6e
Application numbers
ANDA208150
Product NDCs
68998-600
Package NDCs
68998-600-01, 68998-600-02
Original packager NDCs

Names & Manufacturers

Brand names
Fluticasone Propionate
Generic names
FLUTICASONE PROPIONATE
Manufacturer names
Marc Glassman, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
FLUTICASONE PROPIONATE
Routes
NASAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1797907
UNII
O2GMZ0LF5W
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each spray) Fluticasone propionate (glucocorticoid) 50 mcg.
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have or had glaucoma or cataracts
Ask Doctor Or Pharmacist (1)

Sequence 1

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)
Do Not Use (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water
Indications And Usage (1)

Sequence 1

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (2)

Sequence 1

Principal Display Panel - Carton CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray Marc Glassman Inc. NDC 68998-600-01 Allergy Relief Fluticasone Propionate Nasal Spray, USP Allergy Symptom Reliever (Glucocorticoid) 120 Metered Sprays Allergy Symptom Reliever Nasal Spray 24 Hour Relief of: Itchy, Watery Eyes Nasal Congestion Runny Nose Itchy Nose Sneezing

Sequence 2

Principal Display Panel - Bottle BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray Marc Glassman Inc. Allergy Relief Fluticasone Propionate Nasal Spray, USP Allergy Symptom Reliever (Glucocorticoid) 120 Metered Sprays
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding , ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Allergy symptom reliever
Questions (1)

Sequence 1

Questions or comments? call toll free 1-800-706-5575 , weekdays, 8:30am – 5:00pm Eastern Standard Time
Spl Product Data Elements (1)

Sequence 1

Fluticasone Propionate Fluticasone Propionate FLUTICASONE PROPIONATE Fluticasone BENZALKONIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED MICROCRYSTALLINE CELLULOSE DEXTROSE, UNSPECIFIED FORM PHENYLETHYL ALCOHOL POLYSORBATE 80 WATER Bottle-label Carton-label
Spl Unclassified Section (1)

Sequence 1

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.
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 1

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.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['ANDA208150'],
 'brand_name': ['Fluticasone Propionate'],
 'generic_name': ['FLUTICASONE PROPIONATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Marc Glassman, Inc.'],
 'package_ndc': ['68998-600-01', '68998-600-02'],
 'product_ndc': ['68998-600'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['NASAL'],
 'rxcui': ['1797907'],
 'spl_id': ['86c50531-67d1-433d-f3ad-37be44686552'],
 'spl_set_id': ['43ac5199-cf46-29a6-b096-d96ee944bf6e'],
 'substance_name': ['FLUTICASONE PROPIONATE'],
 'unii': ['O2GMZ0LF5W']}