NDC 73169-002 Nasal

Oxymetazoline Hydrochloride

NDC Product Code 73169-002

NDC Product Information

Nasal with NDC 73169-002 is a a human over the counter drug product labeled by Dr. Friedman's No More Nosebleed Kit Inc.. The generic name of Nasal is oxymetazoline hydrochloride. The product's dosage form is kit and is administered via form.

Labeler Name: Dr. Friedman's No More Nosebleed Kit Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dr. Friedman's No More Nosebleed Kit Inc.
Labeler Code: 73169
FDA Application Number: part341 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-07-2019 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.

Nasal 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                   Purpose

Oxymetazoline hydrochloride 0.05% Nasal Decongestant

Uses

For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.temporary relieves sinus congestion and pressureshrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you haveheart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate glandWhen using this productdo not use more than directeddo not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsentemporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occuruse 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.

Directions

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. Do not exceed 2 doses in any 24-hour period.Children under 6 years of age: ask a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.Other informationstore at room temperature.

Inactive Ingredients

Benzalkonium Chloride, benzyl Alcohol, edetate disodium, polyethylene glycol, Povidone, propylene glycol, Purified water, Sodium Phosphate dibasic, Sodium Phosphate monobasic.

* Please review the disclaimer below.

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