NDC 57483-350 Nasova Ear Drying Drops

Isopropyl Alcohol 95%

NDC Product Code 57483-350

NDC 57483-350-15

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Nasova Ear Drying Drops with NDC 57483-350 is a a human over the counter drug product labeled by Innovus Pharmaceuticals, Inc.. The generic name of Nasova Ear Drying Drops is isopropyl alcohol 95%. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Nasova Ear Drying Drops 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.


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.

  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Auricular (otic) - Administration to or by way of the ear.

Product Labeler Information

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

Labeler Name: Innovus Pharmaceuticals, Inc.
Labeler Code: 57483
FDA Application Number: part344 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: 11-02-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Nasova Ear Drying Drops Product Label Images

Nasova Ear Drying Drops 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 Ingredients

Isopropyl alcohol 95% in an anhydrous glycerin base

Purpose

Ear drying aid

Uses

Dries water in the ears and relieves water-clogged ears

Warnings

Flammable: Keep away form fire or flame

Do Not Use

In the eyes

Aslk A Doctor Before Use If You Have

  • Ear drainage or dischargepain, irritation, or rash in the earhave had ear surgerydizziness

Stop Use And Ask A Doctor If

Irritation (too much burning) or pain occurs

Keep Out Of Reach Of Children

In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately.

Directions

  • Apply 4 to 5 drops in each affected ear

Other Information

  • Store at room temperatureKeep tightly closed

Inactive Ingredients

Glycerin

Questions?

Call 1.800.996.5122 (Mon-Fri 9AM-5PM EST)

* Please review the disclaimer below.