NDC 57483-080 Fluticare Nasal Allergy
Fluticasone Propionate (glucocorticoid) Spray, Metered Nasal

Product Information

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.

NDC Product Code57483-080
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Fluticare Nasal Allergy
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Fluticasone Propionate (glucocorticoid)
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Fluticasone Propionate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormSpray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Nasal - Administration to the nose; administered by way of the nose.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Innovus Pharmaceuticals Inc.
Labeler Code57483
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		ANDA208024
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-15-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Fluticare Nasal Allergy?


Product Packages

NDC Code 57483-080-02

Package Description: 1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE

Product Details

What are Fluticare Nasal Allergy Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • 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

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

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


Purpose



Allergy symptom reliever


Uses



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

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

Warnings



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.



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


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 monthsa 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



  • 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



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


Questions Or Comments?



Call toll-free 1-800-262-9010

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


Package/Label Principal Display Panel



image description - C rcle FP Nasal Spray 50mcg 120ct Carton Proposed Art 09 08 2022

image description - C rcle FP Nasal Spray 50mcg 120ct Carton Proposed Art 09 08 2022

image description - C rcle FP Nasal Spray 50mcg 120ct Carton Proposed Art 09 08 2022

image description - C rcle FP Nasal Spray 50mcg 120ct Carton Proposed Art 09 08 2022


* Please review the disclaimer below.