NDC 58988-0193 Nasal Decongestant

Product Information

What is NDC 58988-0193?

The NDC code 58988-0193 is assigned by the FDA to the product Nasal Decongestant which is product labeled by Promex, Llc. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 58988-0193-5 1 bottle in 1 box / 30 ml 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 Code58988-0193
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.
Nasal Decongestant
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Promex, Llc
Labeler Code58988
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.
12-09-2013
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.
12-31-2017
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".
I
NDC Code Structure

What are the uses for Nasal Decongestant?


Product Packages

NDC Code 58988-0193-5

Package Description: 1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Nasal Decongestant 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:

Nasal Decongestant 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.

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Patient Education

Oxymetazoline Nasal Spray

Oxymetazoline Nasal Spray is pronounced as (ok'' see met az' oh leen)

Why is oxymetazoline nasal spray medication prescribed?
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymeta...
[Read More]

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Nasal Decongestant 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



Oxymetazoline HCl 0.05%


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Warnings



Do not use this product for more than 3 days


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate

When Using This Product



  • do not exceed recommended dosage
  • use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop Use And Ask A Doctor If



symptoms persist


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • To spray, squeeze bottle qiuckly and firmly
  • Do not tilt head backward while spraying
  • Wipe nozzle clean after use
  • Do not exceed 2 doses in any 24 hour period
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
  • chlidren under 6 years of age: ask a doctor


Other Information



  • store at room temperature 15 - 30°C (59-86°F)
  • retain carton for future reference on full labeling
  • SAFETY SEAL: Do not use if seal on bottle is broken or missing

Inactive Ingredients



benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water


Carton Image




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