NDC 51824-014 Careall Musle And Joint
Menthol Gel Topical

Product Information

What is NDC 51824-014?

The NDC code 51824-014 is assigned by the FDA to the UNFINISHED product Careall Musle And Joint which is a human over the counter drug product labeled by New World Imports, Inc. The generic name of Careall Musle And Joint is menthol. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 51824-014-03 85 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code51824-014
Proprietary Name 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.		Careall Musle And Joint
Non-Proprietary Name 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.		Menthol
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Menthol
Product Type 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.		Human Otc Drug
Dosage FormGel - 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.
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.		New World Imports, Inc
Labeler Code51824
FDA Application Number 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.		part348
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		06-01-2012
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Careall Musle And Joint?


Product Characteristics

Color(s)WHITE (C48325 - INBETWEEN CLEAR AND WHITE IN COLOR)

Product Packages

NDC Code 51824-014-03

Package Description: 85 g in 1 TUBE

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Careall Musle And Joint Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Careall Musle And Joint Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Careall Musle And Joint Inactive Ingredients UNII Codes

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.

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Careall Musle And Joint Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Otc - Active Ingredient



Menthol 2.5%


Otc - Purpose



Topical Analegesic


Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children.  If swallowed, get medical help of contact a Poison Control Center immediately.


Indications & Usage



For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises


Warnings



For External Use Only.

Do not use:

On wounds or damaged skin

With a heating pad

On children under 12 years of age with arthritis-like conditions

Ask a doctor before use if:

You have redness over the affected area

When using this product:

Avoid contact eith eyes or mucous membranes

Do not bandage tightly

Stop use and ask a Doctor if:

Contiditon worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs


Dosage & Administration



Adults 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor


Inactive Ingredient



Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water


Otc - Questions



You may report serious side effects / Distributed by: NWI, Inc., 160 Athens Way, Nashville,TN 37228.  (615)329-1906


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