NDC 69842-770 Fluticasone Propionate

Fluticasone Propionate

NDC Product Code 69842-770

NDC 69842-770-01

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 60 SPRAY, METERED in 1 BOTTLE, SPRAY

NDC Product Information

Fluticasone Propionate with NDC 69842-770 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Fluticasone Propionate is fluticasone propionate. The product's dosage form is spray, metered and is administered via nasal form.

Labeler Name: Cvs Pharmacy

Dosage Form: Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.

Product Type: Human Otc Drug 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.

Fluticasone Propionate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUTICASONE PROPIONATE 50 ug/1

Inactive Ingredient(s)

About the 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 FORM (UNII: K679OBS311)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Cvs Pharmacy
Labeler Code: 69842
FDA Application Number: ANDA208150 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 05-31-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fluticasone Propionate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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 healedif 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 rashketoconazole pills (medicine for fungal infection)

When Using This Product

  • The growth rate of some children may be slowerstinging or sneezing may occur for a few seconds right after usedo not share this bottle with anyone else as this may spread germsremember 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 tuberculosisyour 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 productyou 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 bottleuse the sprayclean the spray nozzleshake gently before each useuse this product only once a daydo not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERWeek 1 - use 2 sprays in each nostril once dailyWeek 2 through 6 months - use 1 or 2 sprays in each nostril once daily, as needed to treat your symptomsAfter 6 months of daily use - ask your doctor if you can keep usingCHILDREN 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 useuse 1 spray in each nostril once dailyCHILDREN UNDER 4 YEARS OF AGEdo 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

* Please review the disclaimer below.

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