NDC 72562-103 Tommie Copper Pain Relief Maximum Strength

Trolamine Salicylate 10%

NDC Product Code 72562-103

NDC 72562-103-03

Package Description: 85 g in 1 TUBE

NDC Product Information

Tommie Copper Pain Relief Maximum Strength with NDC 72562-103 is a a human over the counter drug product labeled by Tommie Copper, Inc.. The generic name of Tommie Copper Pain Relief Maximum Strength is trolamine salicylate 10%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Tommie Copper, 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 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.

Tommie Copper Pain Relief Maximum Strength 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.

  • TROLAMINE SALICYLATE 10 g/100g

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.

  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • JUNIPER BERRY (UNII: O84B5194RL)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)

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: Tommie Copper, Inc.
Labeler Code: 72562
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: 12-14-2020 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.

Tommie Copper Pain Relief Maximum Strength Product Label Images

Tommie Copper Pain Relief Maximum Strength 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

Otc - Active Ingredient

Trolamine Salicylate 10%

Otc - Purpose

Topical Analgesic.

Dosage & Administration

For the temporary relief of minor aches and pain associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only.
Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product use only as directed, avoid taking a bath or shower within 1 hour before or after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin.
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Adults and children 12 years of age: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily.
Children under 12 years of age: ask a doctor.

Inactive Ingredient

Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

* Please review the disclaimer below.