Nuvalu Vaporizing Chest Rub

Camphor, Eucalyptus Oil, Menthol


Jc Sales
Human Otc Drug
NDC 72520-111
Nuvalu Vaporizing Chest Rub also known as Camphor, Eucalyptus Oil, Menthol is a human otc drug labeled by 'Jc Sales'. National Drug Code (NDC) number for Nuvalu Vaporizing Chest Rub is 72520-111. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Nuvalu Vaporizing Chest Rub drug includes Camphor (synthetic) - 4.7 g/100g Eucalyptus Oil - 1 g/100g Menthol - 1 g/100g . The currest status of Nuvalu Vaporizing Chest Rub drug is Active.

Drug Information:

Drug NDC: 72520-111
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Nuvalu Vaporizing Chest Rub
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Camphor, Eucalyptus Oil, Menthol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Jc Sales
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CAMPHOR (SYNTHETIC) - 4.7 g/100g
EUCALYPTUS OIL - 1 g/100g
MENTHOL - 1 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 01 Nov, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part348
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:JC SALES
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1042788
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0885490031679
UPC stands for Universal Product Code.
UNII:5TJD82A1ET
2R04ONI662
L7T10EIP3A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
72520-111-24113 g in 1 JAR (72520-111-24)01 Nov, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose cough suppressant and topical analgesic cough suppressant cough suppressant and topical analgesic

Product Elements:

Nuvalu vaporizing chest rub camphor, eucalyptus oil, menthol camphor (synthetic) camphor (synthetic) eucalyptus oil eucalyptus oil menthol menthol nutmeg oil turpentine cedar leaf oil thymol mineral oil petrolatum

Indications and Usage:

Directions: adults and children over 2 years of age; rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. if desired, cover with dry, warm cloth, but keep clothing loose to let the vapors rise to nose and mouth. repeat up to three times daily, especially at bed time, or as directed by a doctor. children under two years of age, consult a doctor.

Warnings:

Warnings: for external use only; do not take by mouth or place in nostrils. avoid excessive heat. never expose this product to flame or place in any container in which you are heating water. never place in microwave oven.

Dosage and Administration:

Uses on chest and throat, to temporarily relieve cough use on aching muscles to temporarily relieve minor aches

Package Label Principal Display Panel:

Label


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.