Fluticasone Propionate Spray, Metered
FDA Label NDC 0363-0652

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Fluticasone Propionate (NDC 0363-0652). 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 (in each spray), purpose, uses, warnings, do not use, ask a doctor or pharmacist before use if you are taking, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 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

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 - Carton (Single)

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Walgreens NDC 0363-0652-01

Allergy Nasal Spray

Fluticasone Propionate 50 mcg per spray

Allergy Symptom Reliever

(Glucocorticoid)

144 sprays

24 Hour Relief of:

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing
  • Carton-label (Carton Label)

    Carton-label (Carton Label)

Principal Display Panel - Bottle

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Walgreens NDC 0363-0652-04

Allergy Nasal Spray

Fluticasone Propionate 50 mcg

144 sprays

Allergy Symptom Reliever

(Glucocorticoid)

Bottle-label (Bottle Label)

Bottle-label (Bottle Label)

Principle Display Panel - Carton (2X144ms)

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray 

Walgreens NDC 0363-0652-02

Allergy Nasal Spray

Fluticasone Propionate 50 mcg per spray­

2 x 144 sprays ­

Allergy Symptom Reliever

(Glucocorticoid)

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing
  • Carton-2x144ms (Carton 2x144ms)

    Carton-2x144ms (Carton 2x144ms)

Principle Display Panel - Bottle (72Ms)

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Walgreens NDC 0363-0652-05

Allergy Nasal Spray

Fluticasone Propionate 50 mcg per spray­

72 sprays

Allergy Symptom Reliever

(Glucocorticoid)

Bottle-72ms (Bottle 72ms)

Bottle-72ms (Bottle 72ms)

Principle Display Panel - Carton (72Ms)

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray 

Walgreens NDC 0363-0652-03

Allergy Nasal Spray

Fluticasone Propionate 50 mcg per spray­

72 sprays 

­Allergy Symptom Reliever 

(Glucocorticoid)

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing
  • Carton-72ms (Carton 72ms)

    Carton-72ms (Carton 72ms)

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