FLUTICASONE PROPIONATE spray, metered

Fluticasone Propionate by

Drug Labeling and Warnings

Fluticasone Propionate by is a Otc medication manufactured, distributed, or labeled by TWIN MED LLC, Apotex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each spray)

Fluticasone propionate 

(glucocorticoid) 50 mcg 

Purpose

Allergy symptom reliever 

Uses

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

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

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 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 (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 4º and 30ºC (39º and 86ºF)
• keep this label 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

Questions or comments

Call toll-free 1-800-935-6737

Principal Display Panel-Label

Principal Display Panel-Carton

INGREDIENTS AND APPEARANCE

FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-389
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)	FLUTICASONE PROPIONATE	50 ug

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DEXTROSE (UNII: IY9XDZ35W2)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-389-14	1 in 1 CARTON	05/01/2025
1		144 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208150	05/01/2025

Labeler - TWIN MED LLC (009579330)

Registrant - TWIN MED LLC (009579330)

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc.		209429182	manufacture(55681-389)