NDC 72562-211 Copperlife Foot

Dimethicone 1%

NDC Product Code 72562-211

NDC 72562-211-01

Package Description: 28 g in 1 TUBE

NDC Product Information

Copperlife Foot with NDC 72562-211 is a a human over the counter drug product labeled by Tommie Copper, Inc.. The generic name of Copperlife Foot is dimethicone 1%. The product's dosage form is cream and is administered via topical form.

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.

Copperlife Foot 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.


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.

  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • OATMEAL (UNII: 8PI54V663Y)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CERAMIDE NP (UNII: 4370DF050B)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PAPRIKA (UNII: X72Z47861V)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GINGER (UNII: C5529G5JPQ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • WATER (UNII: 059QF0KO0R)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TURMERIC (UNII: 856YO1Z64F)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • OAT (UNII: Z6J799EAJK)
  • SORBITOL (UNII: 506T60A25R)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
  • WILLOW BARK (UNII: S883J9JDYX)
  • CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)

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: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-08-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Copperlife Foot 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

Dimethicone 1%

Otc - Purpose

Skin Protectant

Indications & Usage

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

For external use only. When using this product do not get into eyes.
Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
Do not use on deep puncture wounds, animal bites, and serious burns.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health professional.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Apply as needed.

Inactive Ingredient

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Panthenol, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Oil, Boswellia Serrata (Frankincense) Extract, Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Extract, Zingiber Officinale (Ginger) Root Extract, Capsicum Annuum (Paprika) Extract, Curcuma Longa (Tumeric) Root Extract, Trifolium Pratense (Clover) Flower Extract, Salix Alba (Willow) Bark Extract, Avena Sativa (Oat) Kernel Extract, Sorbitol, Lecithin, Xanthan Gum, Oleic Acid, Iron Oxides (CI 77491), Phenoxyethanol, Ethylhexylglycerin, Steareth-20, Sodium Chloride, Colloidal Oatmeal, 4-t-Butylcyclohexanol, Pentylene Glycol, Benzalkonium Chloride, Anthemis Nobilis (Roman Chamomile) Flower Oil, Melaleuca Altrnifolia (Tea Tree) Leaf Oil, Ceramide NP.

* Please review the disclaimer below.