Drug label · Respiratory & allergy

Fluticasone — Fluticasone Propionate drug label

openFDA · Retrieved 2026-10-13

Fluticasone label record for fluticasone propionate. The label lists YYBA CORP as labeler/manufacturer. Route: nasal. Includes selected complete prescribing-information sections from openFDA; consult the linked original label for the complete document.

View original source ↗

Reference details

Brand name
Fluticasone
Generic name
FLUTICASONE PROPIONATE
Active substance
FLUTICASONE PROPIONATE
Labeler / manufacturer listed
YYBA CORP
Route
NASAL
Product type
HUMAN OTC DRUG
Application number
ANDA207957
Label version
1
SPL set ID
535b2575-8af8-d951-e063-6394a90ac72d
Label effective date
2026-09-01
openFDA dataset updated
2026-10-13

Indications and usage

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy nose runny nose itchy, watery eyes sneezing

Purpose

Purpose Allergy symptom reliever

Warnings

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 (1-800-222-1222).

Do not use

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 doctor

Ask a doctor before use if you have or had glaucoma or cataracts

Ask doctor or pharmacist

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

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

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

Dosage and administration

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

Pregnancy or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active ingredient

Active ingredient (in each spray) Fluticasone propionate (glucocorticoid)* 50 mcg * read the Question & Answer leaflet

Inactive ingredient

Inactive ingredients benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

Storage and handling

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 o and 30 o C (39 o and 86 o F) keep this package and enclosed materials. They contain important additional information.

Sources and reuse

Selected source label sections. Check the original for the complete label, formatting and latest version.
Selected complete plain-text label sections. Tables and images may require consulting the linked original label. This is a reference copy, not prescribing advice.
Source date: 2026-09-01. Retrieved: 2026-10-13. Text has been organized for reading; this import has not been independently reviewed by a clinician. It is not individualized medical advice.

Related references in Respiratory & allergy