Active Ingredients And Purpose
Active ingredient (in each spray)
Mometasone furoate monohydrate (glucocorticoid) 50 mcg
Purpose
Allergy symptom reliever
Cardinal Health Allergy Nasal Spray Drug Facts
- Manufacturer
- Cardinal Health 110, LLC. dba Leader
- Effective date
- 2025-08-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:10:29
Key Label Information
Uses
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose
Warnings
Warnings
Only for use in the nose. Do not spray into your eyes or mouth.
Directions And Dosage
Directions
Read insert (inside package) for how to: • prime the bottle • use the spray • clean the nozzle • shake well before each use • use this product only once a day • do not use more than directed Adults & children 12 years of age and older • 2 sprays in each nostril once daily while sniffing gently Children 2 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 • 1 spray in each nostril once daily while sniffing gently Children under 2 years of age • do not use
Other Label Information
Other information
• do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact • keep package and insert. They contain important information. • store between 20-25 ° C (68-77 ° F)
Inactive ingredients
benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate
Questions or comments?
Call toll-free 1-800-719-9260
Package/Label Principal Display Panel
LEADER ™ Non-Drowsy | Scent-Free Mist Allergy Nasal Spray Mometasone Furoate Nasal Spray, 50 mcg/Spray Allergy Symptom Reliever (Glucocorticoid)* Allergy + Congestion Full Prescription Strength 24-Hour Relief of: Nasal Congestion Runny Nose Sneezing Itchy Nose COMPARE TO NASONEX ® 24HR ALLERGY active ingredient 100% Money Back Guarantee *Mometasone furoate is a steroid medicine known as a glucocorticoid 60 SPRAYS 0.34 FL OZ (10.0 mL)
Label Images
Products
- Leader Allergy Nasal
- mometasone furoate
- MOMETASONE
NDC Codes
Ingredients
Complete SPL Sections
Active ingredient (in each spray)
Mometasone furoate monohydrate (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
Warnings
Only for use in the nose. Do not spray into your eyes or mouth.
Directions
Read insert (inside package) for how to: • prime the bottle • use the spray • clean the nozzle • shake well before each use • use this product only once a day • do not use more than directed Adults & children 12 years of age and older • 2 sprays in each nostril once daily while sniffing gently Children 2 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 • 1 spray in each nostril once daily while sniffing gently Children under 2 years of age • do not use
Other information
• do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact • keep package and insert. They contain important information. • store between 20-25 ° C (68-77 ° F)
Inactive ingredients
benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate
Questions or comments?
Call toll-free 1-800-719-9260
Consumer information
Mometasone Furoate Nasal Spray, 50 mcg/Spray 1Y800 00 J2 A GETTING STARTED This product works best at relieving your allergy symptoms when you get a full dose. Here’s how to get started, in five easy steps. 1 SHAKE Shake spray bottle well. Remove cap. 2 PRIME Do this when: • Starting a new bottle • Bottle has not been used in one week • Just cleaned nozzle Otherwise go to step 3 Aim away from the face. Grasp spray bottle as shown. Pump until fine mist appears. Pumped ten times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN, other side. NOTE: There is enough medicine in the bottle to allow for priming sprays plus the number of sprays labeled on the bottle. 3 BLOW Blow nose gently to clear nostrils. 4 AIM Close one nostril and put tip of spray nozzle in other nostril. Put just the tip into your nose. Aim slightly away from center of nose. 5 BREATHE AND SPRAY 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. Dosing and Cleaning instructions See other side SIDE 1 B DIRECTIONS FOR USE This product works best when you use it daily. Here’s how to get started. Children age 2-11 An adult should supervise use Use one spray in each nostril once daily. Check with your child’s doctor if child needs to use this product for longer than two months a year. WARNING: Do not spray in your eyes. Only for use in your nose. Users age 12 or older Use two sprays in each nostril every day. Other important information for use • Do not use more than directed. • If you forget a dose, do not double the next dose. • Do not spray into eyes or mouth. • If you get the spray in your eyes, rinse well with water. • If allergy symptoms do not improve after one week, stop using and talk to a doctor. • Do not share this bottle with anyone else as this may spread germs. C 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. Remove spray nozzle by grasping at base and pulling up. Rinse under running tap water, and dry at room temperature. Aim away from your face and gently, but firmly replace spray nozzle. If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3 . Questions or comments? Call toll-free 1-800-719-9260 Store between 20º-25ºC (68º-77ºF) Distributed By Perrigo ® Allegan, MI 49010 SIDE 2
Package/Label Principal Display Panel
LEADER ™ Non-Drowsy | Scent-Free Mist Allergy Nasal Spray Mometasone Furoate Nasal Spray, 50 mcg/Spray Allergy Symptom Reliever (Glucocorticoid)* Allergy + Congestion Full Prescription Strength 24-Hour Relief of: Nasal Congestion Runny Nose Sneezing Itchy Nose COMPARE TO NASONEX ® 24HR ALLERGY active ingredient 100% Money Back Guarantee *Mometasone furoate is a steroid medicine known as a glucocorticoid 60 SPRAYS 0.34 FL OZ (10.0 mL)
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
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Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | b06fcce1-b499-4f0d-a125-55d3ed7a3593.xml | 2025-08-17 |
| otc | leader-allergy-nasal-spray-carton-image.jpg | 2025-08-17 |
| otc | 15700422-897a-4e4c-bfc7-ca10e56a857a.xml | 2024-12-05 |
| otc | 295a44f8-e39b-412f-9353-2190bf490566.xml | 2024-09-06 |
| otc | 26f0fd3d-1bb5-46ac-a995-cfd48249bad8.xml | 2023-09-23 |
| otc | image-01.jpg | 2023-09-23 |
| otc | image-02.jpg | 2023-09-23 |
| otc | image-03.jpg | 2023-09-23 |
| otc | image-04.jpg | 2023-09-23 |
| otc | image-05.jpg | 2023-09-23 |
| otc | image-06.jpg | 2023-09-23 |
| otc | image-07.jpg | 2023-09-23 |
| otc | image-08.jpg | 2023-09-23 |
| otc | image-09.jpg | 2023-09-23 |
| otc | image-10.jpg | 2023-09-23 |
| otc | image-11.jpg | 2023-09-23 |
| otc | image-12.jpg | 2023-09-23 |
| otc | image-13.jpg | 2023-09-23 |
| otc | image-14.jpg | 2023-09-23 |
| otc | image-15.jpg | 2023-09-23 |
| otc | image-16.jpg | 2023-09-23 |
| otc | image-17.jpg | 2023-09-23 |
| otc | image-18.jpg | 2023-09-23 |