NDC 79255-101 Pain Relief

Menthol, Methyl Salicylate

NDC Product Code 79255-101

NDC 79255-101-03

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 90 mL in 1 BOTTLE, SPRAY

NDC Product Information

Pain Relief with NDC 79255-101 is a a human over the counter drug product labeled by Innocan Pharma Ltd.. The generic name of Pain Relief is menthol, methyl salicylate. The product's dosage form is spray and is administered via topical form.

Labeler Name: Innocan Pharma Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Pain Relief 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 100 mg/mL
  • METHYL SALICYLATE 150 mg/mL

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.

  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Innocan Pharma Ltd.
Labeler Code: 79255
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: 07-08-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

Spray

Relief from minor muscle & joint pain associated with arthritis and backaches
Drug Facts

Active Ingredients

Menthol 10%
Methyl Salicylate 15%

Purpose

Topical analgesic
Topical analgesic

Uses

  • Temporarily relief the minor aches and pains of muscles and joints associated with:
  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

For external use only

Otc - Do Not Use

  • Do not use on wounds or damaged skin
  • With heating pad
  • On a child under 12 years of age

Ask A Doctor Before Use If You Have

Redness over the affected area.

When Using This Product

  • Do not bandage tightly
  • Avoid contact with the eyes or mucous membranes

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation occurs

Keep Out Of Reach Of Children To Avoid Accidental Ingestion.

If swallowed, get, medical help or contact a Poison Control Center immediately

Directions

  • Use only as directed
  • Adults and children 12 years of age and older apply to affected area not more than 3 to 4 times daily.
  • Shake well before use
  • Children under 12 years of age: do not use

Other Information

  • Store at 20° to 25° C (68° TO 77° F)

Inactive Ingredients

Cannabidiol, Cannabis sativa (Hemp) Seed oil, Ethylhexylglycerin, Magnesium Chloride, Phenoxyethanol, Polysorbate-20, Purified water

Otc - Questions

  • Questions? 1-855-973-2090
  • PATENT PENDINGUnique FormulationInnocan Pharma combines vast pharmaceutical know-how and experience with highly innovative delivery systems, bringing to market a new generation of HEMP integrated pharmaceutical products.
  • No artificial dyes
  • No synthetic fragrances
  • No Steroids
  • No parabens
  • No petrolatum or phthalates
  • MADE IN USA Manufactured for Innocan Pharma by Biogenesis Inc. 444 Marshall Street, Paterson, NJ 07503
  • Www.innocanpharma.com

* Please review the disclaimer below.