4jointz
Menthol
Arp(usa) Pty Ltd
Human Otc Drug
NDC 71282-0114jointz also known as Menthol is a human otc drug labeled by 'Arp(usa) Pty Ltd'. National Drug Code (NDC) number for 4jointz is 71282-011. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in 4jointz drug includes Menthol - 1.5 g/100g . The currest status of 4jointz drug is Active.
Drug Information:
| Drug NDC: | 71282-011 |
| 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: | 4jointz |
| 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: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Arp(usa) Pty Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | MENTHOL - 1.5 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: | 31 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 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: | ARP(USA) Pty Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1045482
|
| 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. |
| UNII: | 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71282-011-27 | 2 TUBE in 1 PACKAGE (71282-011-27) / 100 g in 1 TUBE | 31 Jan, 2017 | N/A | No |
| 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 topical analgesic
Product Elements:
4jointz menthol menthol menthol aloe vera leaf caprylyl glycol castor oil cetyl alcohol dimethicone hexamethyldisiloxane eucalyptus oil frankincense oil glycerin glyceryl monostearate olive oil peg-100 stearate phenoxyethanol propylene glycol alcohol sodium hydroxide sorbic acid symphytum officinale whole tannic acid urea water xanthan gum
Indications and Usage:
Uses temporarily relieves the aches and pains of muscles and joints associated with: â arthritis â simple backache â strains â bruises â sprains
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
Dosage and Administration:
Directions use only as directed â adults & children 12 years and older: massage gently into affected joints â apply three (3) times daily for optimal results
Package Label Principal Display Panel:
4jointz ® principal display panel live pain free 4jointz ® freedom to move pain relief cream www.4jointz.com 2 x 3.5 oz [100g] tubes â 7 oz [200g] total clinically tested long lasting results 4jointz® freedom to move uniquely formulated for painful, stiff & swollen joints 4jointz ® freedom to move nature & science combined 4jointz ® freedom to move nature & science combined 0 80119 61913 3 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. net wt. 7oz (200g). patent: www.4jointz.com/patent made in the usa of us and imported materials âinner packageâ res 4jointz box v5 4jointz tube v5
Further Questions:
Questions 1-844-4jointz (1-844-456-4689)