FlutiCare Nasal Allergy Spray

Manufacturer
Innovus Pharmaceuticals Inc.
Effective date
2022-09-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:34:43

Label at a glance#

ProductFlutiCare Nasal Allergy
Active ingredientFLUTICASONE PROPIONATE
Label structure10 sections

Indications and uses

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose itchy watery, eyes sneezing itchy nose

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid) 50 mcg

Purpose

OTC - PURPOSE SECTION

Allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: Do not use if plastic sleeve is torn or broken. Under the cap and nozzle, each bottle has an aluminum seal around the bottle neck. Do not use if any of these featurees are torn or damaged.
  • 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 package and enclosed materials. They contain important additional information.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll-free 1-800-262-9010

weekdays (9:00am - 5:00pm EST).

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-08057483-080-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8498a76b-2265-4bd4-a827-121a58584bbafdca7d97-7ed4-4239-be6d-bd1462eb73662023-04-21WarningsExact identifier
spl set id: fdca7d97-7ed4-4239-be6d-bd1462eb7366

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.