Hempvana Cold As Ice Gel
Menthol
Telebrands Corp
Human Otc Drug
NDC 73287-012Hempvana Cold As Ice Gel also known as Menthol is a human otc drug labeled by 'Telebrands Corp'. National Drug Code (NDC) number for Hempvana Cold As Ice Gel is 73287-012. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hempvana Cold As Ice Gel drug includes Menthol - 8 mg/100mL . The currest status of Hempvana Cold As Ice Gel drug is Active.
Drug Information:
| Drug NDC: | 73287-012 |
| 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: | Hempvana Cold As Ice Gel |
| 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: | Telebrands Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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 - 8 mg/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: | 07 Jul, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 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: | Telebrands Corp
|
| 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
|
| 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 |
|---|
| 73287-012-01 | 1 TUBE in 1 CARTON (73287-012-01) / 118 mL in 1 TUBE | 07 Jul, 2020 | 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 menthol usp 8% w/w................topical analgesic
Product Elements:
Hempvana cold as ice gel menthol isopropyl myristate sodium hydroxide menthol menthol water camphor, (-)- turmeric carbomer homopolymer, unspecified type alpha-tocopherol acetate green tea leaf melissa officinalis flowering top edetate disodium edetic acid fd&c blue no. 1 alcohol silica dimethyl silylate ilex paraguariensis leaf phenoxyethanol ethylhexylglycerin fd&c yellow no. 5 glycerin cannabis sativa seed oil aloe vera leaf arctium lappa root arnica montana flower calendula officinalis flowering top
Indications and Usage:
Uses temporarily relief of minor aches and pains of muscles and joints associated with: ⢠simple backache ⢠arthritis ⢠strains ⢠bruises ⢠sprains
Warnings:
For external use only flammable : keep away from excessive heat or open flame when using this product, avoid contact with eyes. do not apply to wounds or damaged skin do nut use in large quantities, particularly over raw surfaces or blistered areas. do not bandage tightly stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of children . if product is swallowed, get medical help or contact a poison control center right away. if pregnant or nursing, ask a healthcare professional before using.
When Using:
When using this product, avoid contact with eyes. do not apply to wounds or damaged skin do nut use in large quantities, particularly over raw surfaces or blistered areas. do not bandage tightly
Dosage and Administration:
Directions adults: apply to affected are not more than 3 to 4 times daily. if product comes in contact with hands, wash with soap and water. for children under 18 years of age : consult a physician.
Stop Use:
Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
Description:
Call (855) 877-4503 (m-f, 9am-5pm est) does not contain nsaids, ibuprofen, aspirin or salicylate for more information visit www.hempvana.com dist. by: telebrands corp. 79 two bridges road fairfield, nj 07004
Package Label Principal Display Panel:
Cold therapy for pain hempvana #1 hemp brand in america cold as ice pain relief gel enriched with hemp seed oil turmeric and aloe menthol usp 8% for arthritis, back, shoulder, joint & muscle pain phthalate free - paraben free - vegan - gluten free - cruelty free 4 fl oz (118 ml) as seen on tv pdp