FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Cardinal Health (Leader) 70000
Effective date
2023-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:36:07

Label at a glance#

ProductAllergy Relief
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 sneezing itchy nose itchy, watery eyes

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 use – ask ...

Storage and handling

TAMPER EVIDENT: Do not use if plastic sleeve is torn or broken. Under the cap and nozzle, each bottle has an aluminum seal around bottle neck. Do not use if any of these features 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 carton and enclosed insert. They contain important additional...

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticold) 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
  • sneezing
  • itchy nose
  • itchy, watery eyes

Warnings

WARNINGS SECTION

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

Do not use

SPL UNCLASSIFIED SECTION

  • 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

OTC - ASK DOCTOR SECTION

have or had glaucoma or cataracts

Ask a Doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222) right away

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

STORAGE AND HANDLING 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 bottle neck. Do not use if any of these features 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 carton and enclosed insert. They contain important additional information.

Inactive ingredient

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO FLONASE® active ingredient*

Full Prescription Strength

Fluticasone Propionate

Nasal Spray (Glucocorticoid,

50 mcg per spray

Allergy Symptom Reliever Nasal Spray

Non-Drowsy

24-Hour Relief of:

Itchy, watery eyes,

Itchy Nose, Runny Nose,

Nasal Congestion, Sneezing

METERED SPRAYS

FL OZ (mL)

*This product is not distributed by GlaxoSmithKline, owner of the registered trademark Flonase®.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Allergy Reliever Nasal Spray
LEADER Allergy Reliever Nasal Spray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0613-12024-01-30C16284748780-11030e365-68e4-111a-e063-dadaa90a10e2Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-061370000-0613-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
FLUTICASONE PROPIONATEO2GMZ0LF5WACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
106c1d63-8409-4bac-8fd3-7a24044e5b88f37be31a-2a0a-4e9f-953f-6ab62cb87a882024-07-08WarningsExact identifier
spl set id: f37be31a-2a0a-4e9f-953f-6ab62cb87a88

Reported adverse events (FAERS/openFDA)#

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