Allergy Relief
Drug Facts
7c81d4d6-d688-72ab-9e43-9b2278d1e057
HUMAN OTC DRUG LABEL
Sep 22, 2025
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
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
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
Active ingredient (in each spray)
Fluticasone propionate (glucocorticoid) 50 mcg.
OTC - PURPOSE SECTION
Purpose
Allergy symptom reliever
WARNINGS SECTION
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
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
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
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
Questions or comments?
call toll free1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time