NDC 72839-253 Pain Relief Coppergel

Camphor 3.5%, Menthol 3.5%

NDC Product Code 72839-253

NDC 72839-253-03

Package Description: 1 BOTTLE in 1 CARTON > 89 mL in 1 BOTTLE

NDC Product Information

Pain Relief Coppergel with NDC 72839-253 is a a human over the counter drug product labeled by Derma Care Research Labs, Llc. The generic name of Pain Relief Coppergel is camphor 3.5%, menthol 3.5%. The product's dosage form is spray and is administered via topical form.

Labeler Name: Derma Care Research Labs, Llc

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 Coppergel 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.

  • CAMPHOR (SYNTHETIC) 1 g/100mL
  • MENTHOL 3.5 g/100mL

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)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • COPPER PIDOLATE (UNII: 497G7G1SL1)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Derma Care Research Labs, Llc
Labeler Code: 72839
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: 06-14-2019 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.

Pain Relief Coppergel Product Label Images

Pain Relief Coppergel 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

Camphor 3.5%, Menthol 3.5%

Otc - Purpose

Topical Analgesic

Dosage & Administration

For the temporary relief of itching associated with minor aches and pains in muscles and joints associated with strains, sprains, arthritis, and bruises.

Warnings

For external use only.
Flammable--Do not use while smoking or near heat or flame.
When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.
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, or if redness or irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Clean the affected area before applying products. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Inactive Ingredient

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Copper PCA, Ethyhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Water.

* Please review the disclaimer below.