NDC 51328-2060 Assured Vaporizing Chest Rub

Menthol Camphor Eucalyptus Oil

NDC Product Code 51328-2060

NDC Code: 51328-2060

Proprietary Name: Assured Vaporizing Chest Rub Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 51328 - Royal Exports
    • 51328-2060 - Assured Vaporizing Chest Rub

NDC 51328-2060-1

Package Description: 113 g in 1 JAR

NDC Product Information

Assured Vaporizing Chest Rub with NDC 51328-2060 is a a human over the counter drug product labeled by Royal Exports. The generic name of Assured Vaporizing Chest Rub is menthol camphor eucalyptus oil. The product's dosage form is gel and is administered via topical form.

Labeler Name: Royal Exports

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 Additional informationCallout TooltipWhat 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.


Assured Vaporizing Chest Rub Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR (SYNTHETIC) 5.3 g/113g
  • EUCALYPTUS OIL 1.13 g/113g
  • MENTHOL 2.26 g/113g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)
  • THYMOL (UNII: 3J50XA376E)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Royal Exports
Labeler Code: 51328
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-21-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Assured Vaporizing Chest Rub Product Label Images

Assured Vaporizing Chest Rub 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

Camphor 4.7 % Eucalyptus Oil 1% Menthol 2%

Purpose

Decongestant

Uses

  • Temporarily relieves nasal congestion, chest congestion, and cough due to the common coldtemporarily relieves minor aches and pains

Warnings:

FOR EXTERNAL USE ONLY

When Using This Product

  • Avoid contact with eyesDo not put into mouth, nostrils or on wounds or damaged skin

Consult A Doctor Before Use If

  • You are pregnant or breast feedingyou have ashtma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucusIf mucus lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache

Do Not Use Near

  • Open flamemicrowave ovena container in which water is being heated except when adding cold water to a hot stream vaporizer

Keep Out Of Reach Of Children

  • If ingested, get medical help or contract a Poison Control Center right away

Directions

  • Adults and children 2 years of age and olderrub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore aching musclesIf desired, cover with a soft dry cloth but keep clothing looserepeat up to three times daily especially at bedtimeChildren under 2 years of ageconsult your physician

Inactive Ingredients

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

* Please review the disclaimer below.

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