Green Farm Potent Thermal Relief
Methyl Salicylate, Menthol
Sunset Novelties, Inc
Human Otc Drug
NDC 72937-811Green Farm Potent Thermal Relief also known as Methyl Salicylate, Menthol is a human otc drug labeled by 'Sunset Novelties, Inc'. National Drug Code (NDC) number for Green Farm Potent Thermal Relief is 72937-811. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Green Farm Potent Thermal Relief drug includes Menthol - 9.8 g/100mL Methyl Salicylate - 17.6 g/100mL . The currest status of Green Farm Potent Thermal Relief drug is Active.
Drug Information:
| Drug NDC: | 72937-811 |
| 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: | Green Farm Potent Thermal Relief |
| 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: | Methyl Salicylate, Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sunset Novelties, Inc |
| 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 - 9.8 g/100mL
METHYL SALICYLATE - 17.6 g/100mL
|
| 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: | 02 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | SUNSET NOVELTIES, 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. |
| UNII: | L7T10EIP3A
LAV5U5022Y
|
| 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 |
|---|
| 72937-811-02 | 60 mL in 1 BOTTLE (72937-811-02) | 02 Dec, 2022 | N/A | No |
| 72937-811-04 | 118 mL in 1 BOTTLE (72937-811-04) | 02 Dec, 2022 | N/A | No |
| 72937-811-08 | 237 mL in 1 BOTTLE (72937-811-08) | 02 Dec, 2022 | N/A | No |
| 72937-811-16 | 473 mL in 1 BOTTLE (72937-811-16) | 02 Dec, 2022 | 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:
Topical analgesic.
Product Elements:
Green farm potent thermal relief methyl salicylate, menthol glyceryl monostearate cetyl alcohol glycereth-26 trideceth-6 caprylyl glycol phenoxyethanol comfrey leaf cannabidiol amino acids, wheat menthol menthol water hyaluronate sodium panthenol methyl salicylate salicylic acid hydroxyproline hexylene glycol stearic acid dimethicone 1000 stearyl alcohol trolamine sodium pyrrolidone carboxylate mineral oil fd&c yellow no. 6 light orange
Indications and Usage:
Uses: aid for temporary local relief of minor pain in muscles or joints.
Warnings:
For external use only.
When Using:
Use only as 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, broken or irritated skin a transient burning sensation or redness may occur upon application but generally disappears in several days. if you experience an allergic reaction, discontinue use and consult a doctor. do not expose the area treated with product to heat or direct sunlight.
Dosage and Administration:
Directions: adults an childre over 12 years of age: apply a thin layer to affected areaand rub gently no more than 3 to 4 times daily. wash hands with soap and water after use. children undre 12 years of age; do not use unless directed by a doctor/physician. store at room temperature 15°c - 30°c.
Stop Use:
Stop use and ask a doctor if: condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up occur again within a few days you experience signs injury, such as pain, swelling or blistering where the product was applied.
Package Label Principal Display Panel:
Green farm potent thermal relief cream 2 oz green farm potemt thermal relief 2
Green farm potent thermal relief cream 4 oz green farm potent thermal relief cream 4
Green farm potent thermal relief cream 8 oz green farm potent thermal relief cream 8
Green farm potent thermal relief cream 16 oz green farm potent thermal relief cream 16