365 Whole Foods Market Fluticasone Propionate Spray, Metered
FDA Label NDC 42681-0058

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Whole Foods Market, Inc. for the product 365 Whole Foods Market Fluticasone Propionate (NDC 42681-0058). 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 drug facts, purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each spray)

Fluticasone propionate USP (glucocorticoid)* 50 mcg

*read the Question & Answer Leaflet

Purpose

Allergy symptom reliever

Uses

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


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

Warnings

Only for use in the nose. Do not spray into your eyes or mouth.

FLUTICASONE PROPIONATE NASAL SPRAY, USP


QUICK START GUIDE

HOW TO START GETTING ALLERGY RELIEF RIGHT NOW
   

Figure 6 (Fluticasone Fig6)

Figure 6 (Fluticasone Fig6)


USE THE RIGHT DOSE

Fluticasone Propionate Nasal Spray, USP works best when you use it daily. Here’s how to get started.



                                                                                               Children age 4 to 11

An adult should supervise use

Use one spray in each nostril once daily.


  

Figure 7 (Fluticasone Fig7)

Figure 7 (Fluticasone Fig7)



Don’t use more than one spray in each nostril per day.

If you miss a dose, just use your regular dose the next day. Don’t add an extra dose.


Check with a doctor if a child needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year.


                                                                                                  Users age 12 or older


In your first week


Use two sprays in each nostril every day.

 

Figure 8 (Fluticasone Fig8)

Figure 8 (Fluticasone Fig8)


Don’t use more than two sprays in each nostril per day.

After your first week


If your symptoms are under control, you may reduce to one spray in each nostril every day. If your symptoms get worse, go back to two sprays in each nostril.


If you miss a dose, just use your regular dose the next day. Don’t add an extra dose.

WARNING: Do not spray in your eyes. Only for use in your nose.

 

   

Figure 9 (Fluticasone Fig9)

Figure 9 (Fluticasone Fig9)

 

 

  

Figure 10 (Fluticasone Fig10)

Figure 10 (Fluticasone Fig10)

KEEP IT CLEAN

A clean spray nozzle helps ensure a full dose. Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object – that can damage it.

  

Figure 11 (Fluticasone Fig11)

Figure 11 (Fluticasone Fig11)


Remove spray nozzle by grasping at base and pulling up.
   
Figure 12 (Fluticasone Fig12)

Figure 12 (Fluticasone Fig12)


Rinse under running tap, and dry at  room temperature.
   
Figure 13 (Fluticasone Fig13)

Figure 13 (Fluticasone Fig13)


Aim away from your face and gently replace spray nozzle until you hear a soft click.
   
Figure 14 (Fluticasone Fig14)

Figure 14 (Fluticasone Fig14)


If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3.

GET THE RELIEF YOU NEED
   
Figure 15 (Fluticasone Fig15)

Figure 15 (Fluticasone Fig15)


Fluticasone Propionate Nasal Spray, USP can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps.

1  Shake
   
Figure 16 (Fluticasone Fig16)

Figure 16 (Fluticasone Fig16)


Gently shake spray bottle.
  
Figure 17 (Fluticasone Fig17)

Figure 17 (Fluticasone Fig17)


Remove translucent cap.

2  Prime

Do this when:

• Starting new bottle
• Haven’t used it in a week
• Just cleaned nozzle

Otherwise go to Step 3.
   

Figure 18 (Fluticasone Fig18)

Figure 18 (Fluticasone Fig18)


Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears.

Pumped six times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN.

3  Blow
   
Figure 19 (Fluticasone Fig19)

Figure 19 (Fluticasone Fig19)


Blow nose gently to clear nostrils.

4  Aim
   
Figure 20 (Fluticasone Fig20)

Figure 20 (Fluticasone Fig20)


Close one nostril and put tip of spray nozzle in other nostril.
  
Figure 21 (Fluticasone Fig21)

Figure 21 (Fluticasone Fig21)


Put just the tip into your nose.
  
Figure 22 (Fluticasone Fig22)

Figure 22 (Fluticasone Fig22)


Aim slightly away from center of nose.

5  Breathe and Spray
  
Figure 23 (Fluticasone Fig23)

Figure 23 (Fluticasone Fig23)


While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth.

Repeat in other nostril.

Wipe spray nozzle with clean tissue and replace cap.

DISTRIBUTED BY:
WHOLE FOODS MARKET
550 BOWIE STREET, AUSTIN, TX 78703
©2025 WHOLE FOODS MARKET IP, INC.
www.wholefoodsmarket.com

 

PRODUCT OF INDIA


Code: AP/DRUGS/04/2016


Revised: 01/2026

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

Inactive Ingredients

benzalkonium chloride, dextrose anhydrous, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol, polysorbate 80, and purified water

Questions Or Comments?

call 1-855-274-4122  (Monday – Friday 8:30 AM to 5:00 PM EST)


DISTRIBUTED BY:
WHOLE FOODS MARKET
550 BOWIE STREET, AUSTIN, TX 78703
©2025 WHOLE FOODS MARKET IP, INC.
www.wholefoodsmarket.com

PRODUCT OF INDIA

Code: AP/DRUGS/04/2016

Other



If the label says…
The bottle should last age 12+…
The bottle should last age 4 to 11…
30 sprays
1 week
2 weeks
60 sprays
2 weeks
4 weeks
72 sprays
2.5 weeks
5 weeks
90 sprays
3 weeks
6 weeks
144 sprays
5 weeks
10 weeks*
 
 
*Check with a doctor if a child 4 to 11 needs to use longer than 2 months a year

Is Fluticasone Propionate Nasal Spray, USP OK to use with other medicines?


You should tell your doctor about all the medicines you take, including Fluticasone Propionate Nasal Spray, USP. Fluticasone Propionate Nasal Spray, USP can be used with most non-prescription and prescription medicines. However, there are a few medicines to look out for because they may cause the level of Fluticasone Propionate Nasal Spray, USP in your body to become too high. Just to be safe, check this table to see if you’re taking any of these medicines.


If you’re taking...
Here’s what to do…
Medicines for HIV infection
(such as ritonavir)
Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP
Medicines with glucocorticoids
Including some medicines for skin rash such as eczema, asthma, inflammation, allergic reactions, or eye conditions
Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP
Ketoconazole
Pills for fungal infection
Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP

 

What are the differences in the way children age 4 to 11 should use Fluticasone Propionate Nasal Spray, USP?

Children age 4 to 11 should use a lower dose of Fluticasone Propionate Nasal Spray, USP for a shorter period of time.


 AgesChildren 4 to 11 years of age Users 12 years of age and older 
 Dosage1 spray in each nostril once dailyUp to 2 sprays in each nostril once daily
 Duration before checking with a doctorUp to 2 months of use a yearUp to 6 months of daily use

Why is the use of Fluticasone Propionate Nasal Spray, USP for children age 4 to 11 limited to 2 months a year before checking with a doctor?


When used long-term, intranasal glucocorticoids like Fluticasone Propionate Nasal Spray, USP may cause the growth rate of some children to be slower. Whether this will affect a child’s ultimate height is not known. As a precaution, 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.

What To Expect


What it’s like to use Fluticasone Propionate Nasal Spray, USP.


How soon will I get relief?

You may start to feel relief the first day you use Fluticasone Propionate Nasal Spray, USP. Keep using it every day, though. It takes several days before Fluticasone Propionate Nasal Spray, USP builds up to full effectiveness.


How long will the relief last?


Fluticasone Propionate Nasal Spray, USP is meant to control your symptoms every day, all day and all night. To help you get this lasting relief, it’s important to use Fluticasone Propionate Nasal Spray, USP regularly, once a day.


Does Fluticasone Propionate Nasal Spray, USP cause a "rebound" effect?


No, Fluticasone Propionate Nasal Spray, USP does not cause a rebound effect.


Some nasal decongestant sprays may cause your nasal passages to swell up even more when you use them too often or for longer than their label says you should (three days). This is sometimes called a “rebound effect.”

Fluticasone Propionate Nasal Spray, USP is a different kind of medicine and does not cause any rebound effect. You can use Fluticasone Propionate Nasal Spray, USP for up to six months if you are age 12 or older or up to two months a year if you are age 4 to 11 before checking with a doctor.


Will Fluticasone Propionate Nasal Spray, USP make me drowsy?


No, Fluticasone Propionate Nasal Spray, USP does not cause drowsiness. Some allergy medications can cause drowsiness, but Fluticasone Propionate Nasal Spray, USP does not.


Why does Fluticasone Propionate Nasal Spray, USP have a smell?


The light floral scent you may notice comes from one of the important ingredients in the Fluticasone Propionate Nasal Spray, USP formula. No fragrance is added to Fluticasone Propionate Nasal Spray, USP.


What if little or nothing is spraying out?


Try priming the spray bottle. It may take a few pumps to get the dispenser spraying again. If that doesn’t work, the spray nozzle may be clogged.

You can clean it following the directions in the Quick Start Guide on the other side.

What if I feel stinging in my nose, or I sneeze?


Some people may feel a slight stinging, or may sneeze, after spraying Fluticasone Propionate Nasal Spray, USP in their nostrils. This feeling should go away in a few seconds.


What if I feel or taste the medicine in my throat?


Generally, you can avoid this by taking a shallower breath next time you spray Fluticasone Propionate Nasal Spray, USP into your nostrils. For example, take the kind of breath you would use to smell a flower.


What if I have chicken pox, measles or tuberculosis or come into contact with someone who does?


Stop using Fluticasone Propionate Nasal Spray, USP and ask your doctor.

What if I’m having severe sinus pain?

If you feel severe pain in your face, have thick nasal discharge, or think you may have a sinus infection,  stop using Fluticasone Propionate Nasal Spray, USP and see your doctor. Your doctor may want to consider if other medicines are needed.


What if my symptoms aren’t better after one week?


If you have used Fluticasone Propionate Nasal Spray, USP for a week and your allergy symptoms are not getting better, stop use and ask your doctor. You may have an infection.


Does Fluticasone Propionate Nasal Spray, USP have side effects?


Serious side effects are rare with Fluticasone Propionate Nasal Spray, USP because Fluticasone Propionate Nasal Spray, USP works in your nose, and barely any of it travels through your body. However, like all medicines, Fluticasone Propionate Nasal Spray, USP can cause side effects in some people.


Here are some side effects that have been reported when using Fluticasone Propionate Nasal Spray, USP. If you have any concerns about side effects, talk with your doctor.



 Side effectWhat could happen What to do 
 Allergic reaction to the product• Sudden swelling of face or tongue 
• A rash
• Wheezing or feeling faint		 If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away.
 Nose injury • Severe or frequent nosebleeds Apply pressure to your nose. Stop using Fluticasone Propionate Nasal Spray, USP and see a doctor.
 • Constant whistling sound that does  not go away This could be a sign of damage to your nose. Stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away.
 Eye conditions such as cataracts or glaucoma• Cloudy vision
• Reduced vision		 Have a yearly eye exam to check for these conditions. Read the Drug Facts on the carton for more details.
 Growth effects• Slower growth rate in some  children while using product Talk to your doctor if you are concerned or if a child age 4 to 11 needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year.
 Other side effects• Headaches or sneezing
• Bad taste or smell
• Minor nosebleeds
• Dry or irritated nose or throat.		 Talk to your doctor or pharmacist if you are concerned.

STILL HAVE QUESTIONS? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

DISTRIBUTED BY:
WHOLE FOODS MARKET
550 BOWIE STREET, AUSTIN, TX 78703
©2025 WHOLE FOODS MARKET IP, INC.
www.wholefoodsmarket.com


PRODUCT OF INDIA


Code: AP/DRUGS/04/2016


Revised: 01/2026


Package Label.Principal Display Panel - 50 Mcg Per Spray (60 Metered Sprays, Bottle Label)

NDC 42681-0058-1

365
WHOLE FOODS 
MARKET

24 Hour
  Relief
Non-Drowsy

Allergy Relief
Fluticasone Propionate
Nasal Spray, USP
(Glucocorticoid)
50mcg per spray
Allergy Symptom Reliever

60 METERED    0.34 FL OZ
SPRAYS             (9.9 mL)

 

Figure (Fluticasone Fig24)

Figure (Fluticasone Fig24)

Package Label.Principal Display Panel - 50 Mcg Per Spray (60 Metered Sprays, Carton Label)

NDC 42681-0058-1

365
WHOLE FOODS 
MARKET

Compare to the Active
Ingredient in Flonase®
Allergy Relief**

Allergy Relief
Fluticasone Propionate
Nasal Spray, USP
(Glucocorticoid)*
50mcg per spray
Allergy Symptom Reliever

Relief of Nasal Congestion, Itchy, Watery
Eyes, Itchy Nose, Runny Nose & Sneezing

24 Hour                              60 
  Relief                           METERED
Non-Drowsy                   SPRAYS

Full Prescription Strength              0.34 FL OZ (9.9 mL)
*Fluticasone propionate is a steroid medicine known as a glucocorticoid.

Figure (Fluticasone Fig25)

Figure (Fluticasone Fig25)


* Please review the disclaimer below.