Assured Pain Relief Hot Menthol
Menthol
Greenbrier International, Inc
Human Otc Drug
NDC 33992-6156Assured Pain Relief Hot Menthol also known as Menthol is a human otc drug labeled by 'Greenbrier International, Inc'. National Drug Code (NDC) number for Assured Pain Relief Hot Menthol is 33992-6156. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Assured Pain Relief Hot Menthol drug includes Capsaicin - 8.3 mg/100mg Menthol - 30 mg/100mg . The currest status of Assured Pain Relief Hot Menthol drug is Active.
Drug Information:
| Drug NDC: | 33992-6156 |
| 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: | Assured Pain Relief Hot Menthol |
| 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: | Greenbrier International, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| 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: | CAPSAICIN - 8.3 mg/100mg
MENTHOL - 30 mg/100mg
|
| 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: | 17 Oct, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| 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: | Greenbrier International, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0639277061560
|
| UPC stands for Universal Product Code. |
| UNII: | S07O44R1ZM
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 |
|---|
| 33992-6156-3 | 2 POUCH in 1 CARTON (33992-6156-3) / 30 mg in 1 POUCH | 17 Oct, 2014 | 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:
Uses temporarily relieves minor pain associated with: arthritis simple backche bursitis tendonitis muscle strains music sprains bruises cramps
Product Elements:
Assured pain relief hot menthol menthol aloe vera leaf aluminum hydroxide castor oil edetate disodium gelatin glycerin isopropyl myristate kaolin magnesium aluminum silicate methylparaben polyethylene glycol 1000 polysorbate 80 polyvinyl alcohol water sodium polyacrylate (8000 mw) tartaric acid titanium dioxide .alpha.-tocopherol acetate menthol menthol capsaicin capsaicin
Indications and Usage:
Directions adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily. children under 12 years of age: do not use, consult a doctor. for easy application: partially peel back protective film and apply exposed film and apply exposed patch to site of pain. carefully remove remaining film while pressing patch to skin for secure adhesion.
Warnings:
For external use only if pregnant or breast feeding, ask a health professional before use.
When Using:
When using this product use as only directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin
Dosage and Administration:
Distributed by greenbrier international, inc. 500 volvo parkway chesapeake, va 23320 made in korea
Stop Use:
Stop use and ask a doctor if condition worsens symptoms persist more than 7 days or clear up and occur again within a few days redness is present skin irritation develops do not apply to wounds or damanged skin
Package Label Principal Display Panel:
Image description