NDC 64092-403 Nasal Decongestant

Menthol, Camphor, Eucalyptus Oil

NDC Product Code 64092-403

NDC CODE: 64092-403

Proprietary Name: Nasal Decongestant 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.

Non-Proprietary Name: Menthol, Camphor, Eucalyptus Oil 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 64092 - Great Lakes Wholesale, Marketing, And Sales, Inc

NDC 64092-403-04

Package Description: 110 g in 1 JAR

NDC Product Information

Nasal Decongestant with NDC 64092-403 is a a human over the counter drug product labeled by Great Lakes Wholesale, Marketing, And Sales, Inc. The generic name of Nasal Decongestant is menthol, camphor, eucalyptus oil. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1042788.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Nasal Decongestant 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.

  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Great Lakes Wholesale, Marketing, And Sales, Inc
Labeler Code: 64092
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: 06-30-2016 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: 12-31-2021 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.

Nasal Decongestant Product Label Images

Nasal Decongestant 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

Description

GLS PERSONAL CARE SOLUTIONSVaporizing Chest RubDecongestant and cough suppressantNET WT. 4 OZ. (110g)

Otc - Active Ingredient

Active Ingredients PurposeMenthol 1.0%........................................................................DecongestantCamphor 4.7%......................................................................DecongestantEucalytus Oil 1.0%................................................................Decongentant

Otc - Purpose

Temporarily relieve nasal congestion, chest congestion and cough.

Indications & Usage

To temporarily relieve nasal congestion, chest congestion and cough due to the common cold.Temporarily relieves minor aches and pains.

Warnings

For external use only.Not for internal use.Avoid contact with eyes.Do not put in mouth, notsrils or on wounds or damaged skin.Do not use near open flame, in a microwave oven or in a container in which water is being heated, except when adding to cold water in a hot steam vaporizer.

Otc - Pregnancy Or Breast Feeding

Consult a physician before use.

Otc - Ask Doctor

If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus.If muscle aches persist for more than 7 days or come back, or if cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.

Otc - Keep Out Of Reach Of Children

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

Instructions For Use

Adults and children 2 years of age and older, rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles.If desired, loosely cover with a soft dry cloth, but keep clothing loose.Repeat up to three times daily, especially at bedtime.Children under 2 years of age, consult your physician.

Dosage & Administration

Topical decongestant and cough suppressant gel1.0% Menthol4.7% Camphor1.0% Eucalyptus Oil

Inactive Ingredient

Petrolatum, Mineral oil, Nutmeg oil, Turpentine Oil, Thymol, Cedar Leaf Oil.

* Please review the disclaimer below.