MedPath

Allergy Relief

Drug Facts

Approved
Approval ID

7c81d4d6-d688-72ab-9e43-9b2278d1e057

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 22, 2025

Manufacturers
FDA

Quality Home Products

DUNS: 205554157

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 Code64525-6560
Application NumberANDA208150
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (8)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/2/2024

Principal Display Panel- Carton 72ms

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Allergy Relief

Fluticasone Propionate Nasal Spray, USP

**50 mcg per spray (Glucocorticoid)**­

72 metered sprays****Allergy Symptom Reliever Nasal Spray

64525-6560-2

24 Hour Relief of:

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Carton-72ms

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/17/2018

Uses

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

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2015

Active ingredient (in each spray)

Fluticasone propionate (glucocorticoid) 50 mcg.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/11/2013

Purpose

Allergy symptom reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 11/11/2013

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/11/2013

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/11/2013

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 11/11/2013

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: 11/11/2013

Questions or comments?

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