MedPath

Fluticasone Propionate

448 - Fluticasone Propionate Nasal Spray 72 Metered Spray

Approved
Approval ID

a4e1c265-5205-4089-8190-0755ede83896

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Nov 28, 2023

Manufacturers
FDA

Allegiant Health

DUNS: 079501930

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fluticasone Propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69168-448
Application NumberANDA208150
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateNovember 28, 2023
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/28/2023

Principal Display Panel

![Carton](/dailymed/image.cfm?name=448---fluticasone-propionate-nasal- spray-72-metere-1.jpg&id=895172)

Carton

![Label](/dailymed/image.cfm?name=448---fluticasone-propionate-nasal- spray-72-metere-2.jpg&id=895172)

Label

![Insert Front](/dailymed/image.cfm?name=448---fluticasone-propionate-nasal- spray-72-metere-3.jpg&id=895172)

Insert Front

![Insert Back](/dailymed/image.cfm?name=448---fluticasone-propionate-nasal- spray-72-metere-4.jpg&id=895172)

Insert Back

![Carton](/dailymed/image.cfm?name=448---fluticasone-propionate-nasal- spray-72-metere-5.jpg&id=895172)

Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/28/2023

Use(s)

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose
  • itchy, watery eye

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/28/2023

Active ingredient(s)

Fluticasone propionate (glucocorticoid) 50 mcg per spray

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/28/2023

Purpose

Allergy symptom reliever

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/28/2023

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 4º and 30ºC (39º and 86ºF)
  • keep this carton and enclosed materials. They contain important additional information.

WARNINGS SECTION

LOINC: 34071-1Updated: 11/28/2023

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

have or had glaucoma or cataracts.

Ask a doctor or pharmacist before use if

  • 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 breastfeeding,

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/28/2023

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 daily
  • Week 2 through 6 months: use 1 or 2 sprays in each nostril once daily, as needed to treat symptoms
  • After 6 months of daily use: ask a doctor if you can keep using

CHILDREN 4 to 11 YEARS OF AGE

  • the growth 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 2 months a year.
  • an adult should supervise use
  • use 1 spray in each nostril daily

CHILDREN UNDER 4 YEARS OF AGE

do not use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/28/2023

Inactive ingredients

0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/28/2023

Questions/Comments

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