Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID f05689fa-7ff3-0846-c647-bdbe79cb2ff8
Route
NASAL
Published
Effective Date 2025-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluticasone (50 ug)
Inactive Ingredients
Benzalkonium Chloride Carboxymethylcellulose Sodium, Unspecified Microcrystalline Cellulose Dextrose, Unspecified Form Phenylethyl Alcohol Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-07-01

Description

Fluticasone propionate (glucocorticoid) 50 mcg.

Purpose

Allergy symptom reliever


Medication Information

Purpose

Allergy symptom reliever

Description

Fluticasone propionate (glucocorticoid) 50 mcg.

Use

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.

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

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
Package Label
KROGER HEALTH Allergy Relief Nasal Spray
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°C and 30°C (39°F and 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 1-800-632-6900

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
Ask A Doctor Before Use If You

have or had glaucoma or cataracts

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.

Active Ingredient (in Each Spray)

Fluticasone propionate (glucocorticoid) 50 mcg.

Principle Display Panel Carton (2x144ms)

COMPARE TO THE ACTIVE INGREDIENT IN FLONASE® ALLERGY RELIEF*

FULL PRESCRIPTION STRENGTH

Allergy Relief 

Nasal Spray

FLUTICASONE PROPIONATE, USP

(GLUCOCORTICOID)†

50 mcg PER SPRAY

ALLERGY SYMPTOM RELIEVER

NON-DROWSY

24-HOUR RELIEF OF:

ITCHY, WATERY EYES 

NASAL CONGESTION

RUNNY NOSE

ITCHY NOSE

SNEEZING

FL OZ (mL)

*FLONASE® IS A REGISTERED TRADEMARK OF GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) IP LIMITED.

†Fluticasone propionate is a steroid medicine known as a glucocorticoid.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED, TORN OR BROKEN OR IF THE SEAL AROUND THE PRODUCTLABELED "SEAL FOR YOUR PROTECTION" IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED 

BY THE KROGER CO.

CINCINNATI, OHIO 45202

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)

Structured Label Content

Use

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

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

Allergy symptom reliever

Warnings

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

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

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
Package Label (Package label)
KROGER HEALTH Allergy Relief Nasal Spray
Other Information (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°C and 30°C (39°F and 86°F)
  • keep this label and enclosed materials. They contain important additional information.
Inactive Ingredients (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? (Questions or comments?)

call 1-800-632-6900

When Using This Product (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 (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
Ask A Doctor Before Use If You (Ask a doctor before use if you)

have or had glaucoma or cataracts

If Pregnant 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 (1-800-222-1222) right away.

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Fluticasone propionate (glucocorticoid) 50 mcg.

Principle Display Panel Carton (2x144ms) (Principle Display Panel - Carton (2x144ms))

COMPARE TO THE ACTIVE INGREDIENT IN FLONASE® ALLERGY RELIEF*

FULL PRESCRIPTION STRENGTH

Allergy Relief 

Nasal Spray

FLUTICASONE PROPIONATE, USP

(GLUCOCORTICOID)†

50 mcg PER SPRAY

ALLERGY SYMPTOM RELIEVER

NON-DROWSY

24-HOUR RELIEF OF:

ITCHY, WATERY EYES 

NASAL CONGESTION

RUNNY NOSE

ITCHY NOSE

SNEEZING

FL OZ (mL)

*FLONASE® IS A REGISTERED TRADEMARK OF GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) IP LIMITED.

†Fluticasone propionate is a steroid medicine known as a glucocorticoid.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED, TORN OR BROKEN OR IF THE SEAL AROUND THE PRODUCTLABELED "SEAL FOR YOUR PROTECTION" IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED 

BY THE KROGER CO.

CINCINNATI, OHIO 45202

Ask A Doctor Or Pharmacist Before Use If You Are Taking (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)

Advanced Ingredient Data


Raw Label Data

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