NDC 68196-210 Fluticasone Propionate
Spray, Metered Nasal

Product Information

Product Code68196-210
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.
Fluticasone Propionate
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
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.
Sam's West Inc.
Labeler Code68196
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.
ANDA208150
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.
01-27-2021
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.
12-31-2022
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

Usage Information


Product Packages

NDC 68196-210-01

Package Description: 6 BOTTLE, SPRAY in 1 CARTON > 6 SPRAY, METERED in 1 BOTTLE, SPRAY

NDC 68196-210-02

Package Description: 144 SPRAY, METERED in 1 BOTTLE, SPRAY

Product Details

Fluticasone Propionate is a human over the counter drug product labeled by Sam's West Inc.. The product's dosage form is spray, metered and is administered via nasal form.


What are Fluticasone Propionate Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)


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.

Fluticasone Propionate Labeling and Warnings

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.

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 • sneezing • itchy nose • itchy, watery eyes


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 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

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


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 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



  • you may start to feel relief the first day and full effect after several days of regular, once-a-day use
  •  store at 4° to 30°C (39° to 86°F)
  • keep this label and enclosed materials. They contain important additional information.

Inactive Ingredients



0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water


Questions Or Comments?



call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time


Principal Display Panel - Carton



CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Aller-Nose Nasal Spray

Fluticasone Propionate Nasal Spray, USP

Apotex Corp. NDC 68196-210-01

6 bottles (144 sprays each)

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

Principal Display Panel - Bottle



BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Aller-Nose Nasal Spray

Fluticasone Propionate Nasal Spray, USP

Apotex Corp. NDC 68196-210-02

144 sprays 0.62 fl oz (18.2 mL)

Allergy Symptom Reliever Nasal Spray


* Please review the disclaimer below.