NDC 71282-011 4jointz
Menthol Cream Topical

Product Information

Product Code71282-011
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.
4jointz
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
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 FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Arp(usa) Pty Ltd
Labeler Code71282
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.
01-31-2017
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.
12-31-2022
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
NDC Code Structure

Usage Information


Product Packages

NDC 71282-011-27

Package Description: 2 TUBE in 1 PACKAGE > 100 g in 1 TUBE

Product Details

4jointz is a human over the counter drug product labeled by Arp(usa) Pty Ltd. The generic name of 4jointz is menthol. The product's dosage form is cream and is administered via topical form.


What are 4jointz Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPYRROLIDONE (UNII: JR9CE63FPM)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBIC ACID (UNII: X045WJ989B)
  • SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)
  • TANNIC ACID (UNII: 28F9E0DJY6)
  • TETRAHYDROPIPERINE (UNII: 8904DO502T)
  • UREA (UNII: 8W8T17847W)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)


* Please review the disclaimer below.

4jointz Labeling and Warnings

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.

Table of Contents



Purpose



Topical analgesic


Do Not Use



  • on open wounds or damaged skin
  • on a child under 12 years of age with arthritis-like conditions
  • near the eyes

Ask A Doctor If



  • conditions worsen
  • symptoms clear up and occur again in a few days
  • redness or irritation develops

Questions



1-844-4JOINTZ (1-844-456-4689)


Other



Tube Labeling

3.5oz/100g


4JOINTZ®
FREEDOM TO MOVE

Uniquely formulated for painful, stiff and swollen joints

Drug Facts

Active Ingredients                  Purpose
Menthol 1.5% ………….......Topical analgesic

Uses

Temporarily relieves the aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
  • Warnings For external use only.

    Do not use

    • on open wounds or damaged skin
    • on a child under 12 years of age with arthritis-like conditions
    • near the eyes
    • Ask a doctor if

      • conditions worsen
      • symptoms clear up and occur again in a few days
      • redness or irritation develops
      • Keep out of reach of children.

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

        Directions

        Use only as directed

        • adults & children 12 years and older: massage gently into affected joints
        • apply three (3) times daily for optimal results
        • Other information

          Store below 30°C (86°F)

          Inactive ingredients

          aloe barbadensis leaf gel, caprylyl glycol, castor oil, cetyl alcohol, deionized water, dimethicone, disiloxane, eucalypyus oil, frankincense oil, glycerine, glyceryl stearate, N-methyl-2-pyrrolidone, olive oil, PEG-100 stearate, phenoxyethanol, propylene glycol,
          SD alcohol, sodium hydroxide, sorbic acid, symphytum officinale (comfrey), tannic acid, tetrahydropiperine, urea, xanthan gum

          Questions 1-844-4JOINTZ (1-844-456-4689)

          Manufactured for ARP (USA) Pty Ltd, 2A, Ground Floor, 15 Lake St.

          Varsity Lakes QLD 4227 Australia. Visit www.4Jointz.com for further

          details and to see how 4Jointz has helped people just like you.

          CLINICALLY TESTED LONG-LASTING RESULTS

          Made in USA - Patent: www.4Jointz.com/patent


* Please review the disclaimer below.