NDC 73287-014 Hempvana Ultra Strength Pain Relief Gel - Arthritis

Menthol 8%

NDC Product Code 73287-014

NDC CODE: 73287-014

Proprietary Name: Hempvana Ultra Strength Pain Relief Gel - Arthritis What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol 8% What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73287 - Telebrands Corp
    • 73287-014 - Hempvana Ultra Strength Pain Relief Gel - Arthritis

NDC 73287-014-01

Package Description: 1 JAR in 1 CARTON > 119 g in 1 JAR

NDC Product Information

Hempvana Ultra Strength Pain Relief Gel - Arthritis with NDC 73287-014 is a a human over the counter drug product labeled by Telebrands Corp. The generic name of Hempvana Ultra Strength Pain Relief Gel - Arthritis is menthol 8%. The product's dosage form is gel and is administered via topical form.

Labeler Name: Telebrands Corp

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hempvana Ultra Strength Pain Relief Gel - Arthritis Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 8 g/8g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • CAMPHOR, (-)- (UNII: 213N3S8275)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • TURMERIC (UNII: 856YO1Z64F)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Telebrands Corp
Labeler Code: 73287
FDA Application Number: part348 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-12-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hempvana Ultra Strength Pain Relief Gel - Arthritis Product Label Images

Hempvana Ultra Strength Pain Relief Gel - Arthritis Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Menthol 8%

Purpose

Menthol 8%....................Topical Analgesic

Uses

Temporary relief of pain

Warnings

For external use only

Other Safety Information

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Otc - When Using

  • When using this productUse 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.

Otc - Stop Use

  • Stop use and ask a doctor ifCondition worsensSymptoms persist for more than 7 days or clear up and occur again within a few daysRedness is present or irritation develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For Use By Adults OnlyApply generously to affected area.Massage into painful area until thoroughly absorbed into skin.Repeat as necessary, but no more than 4 times daily.

Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Sodium Hydroxide, Silica Silylate, Dimethyl Sulfone, Glucosamine Sulfate, Sodium Chondroitin Sulfate, Cannabis Sativa (Hemp) Seed Oil, Camphor, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Curcuma Longa (Turmeric) Root Extract, Ilex Paraguariensis Leaf Extract, Melissa Officinalis Flower/Leaf/Stem Extract, Phenoxyethanol, Carbomer, Ethylhexylglycerin, Disodium EDTA, Glycerin, Tocopheryl Acetate, Yellow 5 (CI 19140), Blue 1 (CI 42090)

Questions?

Questions? Call (855) 877-4503 (M-F, 9am-5pm EST)

* Please review the disclaimer below.