NDC 51452-036 Point Relief Cold Spot Pain Relieving

Menthol

NDC Product Code 51452-036

NDC Code: 51452-036

Proprietary Name: Point Relief Cold Spot Pain Relieving 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 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

  • 51452 - Fabrication Enterprises
    • 51452-036 - Point Relief Cold Spot Pain Relieving

NDC 51452-036-06

Package Description: 5 g in 1 PACKET

NDC Product Information

Point Relief Cold Spot Pain Relieving with NDC 51452-036 is a a human over the counter drug product labeled by Fabrication Enterprises. The generic name of Point Relief Cold Spot Pain Relieving is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Fabrication Enterprises

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.

Point Relief Cold Spot Pain Relieving 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 120 mg/g

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)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • BROMELAINS (UNII: U182GP2CF3)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Fabrication Enterprises
Labeler Code: 51452
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: 04-01-2019 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: 12-31-2020 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.

Point Relief Cold Spot Pain Relieving Product Label Images

Point Relief Cold Spot Pain Relieving 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:

Menthol - USP 12%

Purpose:

External analgesic

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/ or sprains.

Warnings:

  • For external use onlyAvoid contact with eyes

Do Not Apply

  • To open wounds or damaged skinIf symptoms persist for more than sevan days, discontinue use and consult physician

Keep Out Of Reach Of Children

  • If swallowed, consult physician Do not bandage tightly

Directions:

Apply directly to affected area. Do not use more than four fimes per day.

Other Ingredients:

Aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

* Please review the disclaimer below.

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