Hempvana Pain Relief
Trolamine Salicylate
Telebrands Corp
Human Otc Drug
NDC 73287-001Hempvana Pain Relief also known as Trolamine Salicylate is a human otc drug labeled by 'Telebrands Corp'. National Drug Code (NDC) number for Hempvana Pain Relief is 73287-001. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Hempvana Pain Relief drug includes Trolamine Salicylate - 10 g/100g . The currest status of Hempvana Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 73287-001 |
| 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 Pain Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Hempvana |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Pain Relief |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Trolamine Salicylate |
| 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: | 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: | TROLAMINE SALICYLATE - 10 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: | 10 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | 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: | H8O4040BHD
|
| 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 |
|---|
| 73287-001-01 | 1 JAR in 1 CARTON (73287-001-01) / 119 g in 1 JAR | 10 Jan, 2019 | 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 trolamine salicylate 10%................topical analgesic
Product Elements:
Hempvana pain relief trolamine salicylate water ethylhexyl stearate butylene glycol dimethicone stearic acid medium-chain triglycerides cannabis sativa seed oil glyceryl monostearate peg-100 stearate cetostearyl alcohol sunflower oil allantoin .alpha.-tocopherol acetate, dl- ethylhexylglycerin isohexadecane sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) carbomer copolymer type a (allyl pentaerythritol crosslinked) caprylyl glycol hexylene glycol polysorbate 80 edetate disodium anhydrous d&c green no. 5 sodium hydroxide phenoxyethanol trolamine salicylate salicylic acid
Indications and Usage:
Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises
Warnings:
Warnings for external use only allergy alert : if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. when using this product use only as directed. read and follow all directions and warnings on this label. do not bandage tightly or apply local heat (such as heating pads) to the area of use. avoid contact with eyes or mucous membranes. do not apply to wounds or damaged, broken or irritated skin. do not use at the same time as other topical analgesics. 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 redness is present or irritation develops if pregnant or breast-feeding , ask a health professional before use. keep out of reach of children and pets. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product use only as directed. read and follow all directions and warnings on this label. do not bandage tightly or apply local heat (such as heating pads) to the area of use. avoid contact with eyes or mucous membranes. do not apply to wounds or damaged, broken or irritated skin. do not use at the same time as other topical analgesics.
Dosage and Administration:
Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician massage into painful area until thoroughly absorbed into skin. repeat as necessary, but no more than 4 times daily.
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 redness is present or irritation develops
Description:
Hempvana ® pain relief cream absorbs quickly and goes to work instantly. its unique formula includes a proven active ingredient plus the moisturizing benefit of cold pressed hemp seed* extract for soothing relief to back, neck, shoulders, feet, wrists, calves and more. maximum strength odor free non-irritating no burning non greasy tamper evident: do not use if safety seal on cap is broken or missing. for more information, visit www.hempvanastore.com *complies with federal law. hemp seed extract in the form of oil made by cold-pressing industrial hemp seeds. cultivar. dist. by: telebrands corp. 79 two bridges road, fairfield, nj 07004
Package Label Principal Display Panel:
Packaging hempvana maximum strength pain relief cream original +hemp seed oil trolamine salicylate 10% for pain odor free! net wt. 4 oz (119 g) 1
Further Questions:
Questions? call (855) 877-4503 (m-f, 9am-5pm est)