NDC 57483-080 Fluticare Nasal Allergy
Fluticasone Propionate (glucocorticoid) Spray, Metered Nasal
What is NDC 57483-080?
The NDC code 57483-080 is assigned by the FDA to the product Fluticare Nasal Allergy which is a human over the counter drug product labeled by Innovus Pharmaceuticals Inc.. The generic name of Fluticare Nasal Allergy is fluticasone propionate (glucocorticoid). The product's dosage form is spray, metered and is administered via nasal form. The product is distributed in a single package with assigned NDC code 57483-080-02 1 bottle in 1 carton / 120 spray, metered in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Fluticare Nasal Allergy?
Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
NDC Code 57483-080-02
Package Description: 1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE
What are Fluticare Nasal Allergy Active Ingredients?
- FLUTICASONE PROPIONATE 50 ug/1 - A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.
Fluticare Nasal Allergy Active Ingredients UNII Codes
- FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W)
- FLUTICASONE (UNII: CUT2W21N7U) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1797907 - fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1797907 - fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1996212 - FlutiCare 50 MCG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1996212 - fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Fluticare]
- RxCUI: 1996212 - Fluticare 0.05 MG/ACTUAT Metered Dose Nasal Spray
Fluticare Nasal Allergy Inactive Ingredients UNII Codes
- BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
- PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- WATER (UNII: 059QF0KO0R)
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Fluticare Nasal Allergy Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Active Ingredient (In Each Spray)
Fluticasone propionate (glucocorticoid) 50 mcg
Allergy symptom reliever
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- itchy watery, eyes
- itchy nose
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
- medicine for HIV infection (such as ritonavir)
- a steroid medicine for asthma, allergies or skin rash
- ketoconazole pills (medicine for fungal infection)
- 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
- 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
Ask a doctor or pharmacist before use if you are taking
When using this product
Stop use and ask a doctor if
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 (1-800-222-1222).
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
- 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
- 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 monthsa year.
- an adult should supervise use
- use 1 spray in each nostril once daily
- do not use
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
CHILDREN 4 TO 11 YEARS OF AGE
CHILDREN UNDER 4 YEARS OF AGE
- 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.
benzalkonium chloride, carboxymethylcellulose sodium, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, and purified water
Questions Or Comments?
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weekdays (9:00am - 5:00pm EST).
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