Fluticasone Propionate Spray, Metered
FDA Label NDC 85828-448

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet for the product Fluticasone Propionate (NDC 85828-448). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if you, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You

→ Ask A Doctor Or Pharmacist Before Use If You Are Taking

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breastfeeding,

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions/comments

→ Principal Display Panel

Active Ingredient(S)

Fluticasone propionate (glucocorticoid) 50 mcg per spray

Purpose

Allergy symptom reliever

Use(S)

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

nasal congestion
runny nose
sneezing
itchy nose
itchy, watery eye

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 ingredient

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 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.

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

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 4° and 30°C (39° and 86°F)
keep this carton and enclosed materials. They contain important additional information.

Inactive Ingredients

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