NDC 72418-333 Cannessentia Pain Relief Cream

Trolamine Salicylate

NDC Product Code 72418-333

NDC Code: 72418-333

Proprietary Name: Cannessentia Pain Relief Cream Additional informationCallout TooltipWhat 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: Trolamine Salicylate Additional informationCallout TooltipWhat 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.


Code Structure
  • 72418 - Cannessentia Llc
    • 72418-333 - Cannessentia Pain Relief Cream

NDC 72418-333-15

Package Description: 1 VIAL, GLASS in 1 CARTON > 14.17 g in 1 VIAL, GLASS

NDC Product Information

Cannessentia Pain Relief Cream with NDC 72418-333 is a a human over the counter drug product labeled by Cannessentia Llc. The generic name of Cannessentia Pain Relief Cream is trolamine salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cannessentia Llc

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.


Cannessentia Pain Relief Cream 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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • COD LIVER OIL (UNII: BBL281NWFG)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • LANOLIN (UNII: 7EV65EAW6H)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Cannessentia Llc
Labeler Code: 72418
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: 03-01-2019 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.

Cannessentia Pain Relief Cream Product Label Images

Cannessentia Pain Relief Cream 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

Trolamine salicylate 10%

Purpose

Topical analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:simple backachearthritisstrainssprainsbruisescramps

Warnings

For external use onlyAllergy 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 labeldo not bandage tightly or apply local heat (such as heating pads) to the area of useavoid contact with eyes or mucous membranesdo not apply to wounds or damaged, broken or irritated skindo not use at the same time as other topical analgesics

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last for more than 7 days or clear up and occur again within a few daysredness is presentirritation develops

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children over 12 years:apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but not more than 3to 4 times dailychildren 12 years and younger: ask a doctor

Inactive Ingredients

Coconut oil, cod liver oil (contains vitamin A & vitamin D), fragrances, hemp seed oil, lanolin, light mineral oil, medium-chain triglycerides, microcrystalline wax, paraffin, petrolatum, sodium chloride, terpene essential oil, yellow wax

* Please review the disclaimer below.

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