OTC Medication Information: Fluticasone Propionate

FLUTICASONE PROPIONATE- fluticasone propionate spray, metered
Apotex Corp.

Bottle-label-120msCarton-120ms

Active ingredient (in each spray)

Fluticasone propionate (glucocorticoid) 50 mcg.

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

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.

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

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 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 1-800-706-5575 , weekdays, 8:30am – 5:00pm Eastern Standard Time

Principal Display Panel — Bottle 120ms

BOTTLE LABEL — PRINCIPAL DISPLAY PANEL — 50 mcg per spray

Just Well

Fluticasone Propionate Nasal Spray, USP ­

120 sprays

Allergy Symptom Reliever Nasal Spray

Bottle-label-120ms
(click image for full-size original)

Principal Display Panel — Carton 120ms

CARTON LABEL — PRINCIPAL DISPLAY PANEL — 50 mcg per spray

Just Well

Fluticasone Propionate Nasal Spray, USP ­

120 sprays

­Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing
Carton-120ms
(click image for full-size original)
FLUTICASONE PROPIONATE
fluticasone propionate spray, metered
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-6167
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (Fluticasone) FLUTICASONE PROPIONATE 50 ug
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
DEXTROSE, UNSPECIFIED FORM
PHENYLETHYL ALCOHOL
POLYSORBATE 80
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-6167-1 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 120 SPRAY, METERED in 1 BOTTLE, SPRAY This package is contained within the CARTON (60505-6167-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208150 03/01/2017
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 255092496 manufacture (60505-6167), analysis (60505-6167)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging, LLC 143213275 pack (60505-6167)
Establishment
Name Address ID/FEI Operations
HOVIONE FARMACIENCIA, S.A. 449818434 api manufacture (60505-6167)

Revised: 11/2022 Apotex Corp.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.