NDC 39765-011 Hempvana Pain Relief

Trolamine Salicylate

NDC Product Code 39765-011

NDC Product Information

Hempvana Pain Relief with NDC 39765-011 is a a human over the counter drug product labeled by Neutraderm, Inc.. The generic name of Hempvana Pain Relief is trolamine salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Neutraderm, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Pain Relief Active Ingredient(s)

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

  • TROLAMINE SALICYLATE 10 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Neutraderm, Inc.
Labeler Code: 39765
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-10-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hempvana Pain Relief Product Label Images

Hempvana Pain Relief 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 Ingredients:

Trolamine Salicylate (10%)

Purpose

External analgesic

Use

HempvanaTM Pain Relief Cream absorbs quickly and goes to work instantly. Its unique formula includes a known active ingredient for soothing relief to back, neck, shoulders, feet, wrists, calves and more. Plus the moisturizing benefit of cold pressed hempseed oil.

Warnings

  • For external use onlyAvoid contact with eyes or mucous membranes.Do not apply to wounds or damaged, broken or irritated skinDo not use at the same time as other topical analgesics.Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is 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, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa Seed Oil, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Isohexadecane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Hexylene Glycol, Polysorbate 80, Disodium EDTA, Green 5 (CI 61570), Sodium Hydroxide, Phenoxyethanol

* Please review the disclaimer below.

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