NDC 71101-909 Theracare Medicated Pain Relief Patches
Camphor, Menthol, Methyl Salicylate Patch Topical

Product Information

What is NDC 71101-909?

The NDC code 71101-909 is assigned by the FDA to the product Theracare Medicated Pain Relief Patches which is a human over the counter drug product labeled by Veridian Healthcare. The generic name of Theracare Medicated Pain Relief Patches is camphor, menthol, methyl salicylate. The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 71101-909-06 6 patch in 1 box / 9 g in 1 patch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code71101-909
Proprietary Name 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.		Theracare Medicated Pain Relief Patches
Non-Proprietary Name 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.		Camphor, Menthol, Methyl Salicylate
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Camphor (synthetic); Menthol; Methyl Salicylate
Product Type 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.		Human Otc Drug
Dosage FormPatch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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.		Veridian Healthcare
Labeler Code71101
FDA Application Number 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.		part348
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-01-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Theracare Medicated Pain Relief Patches?


Product Characteristics

ShapeSQUARE (C48350)

Product Packages

NDC Code 71101-909-06

Package Description: 6 PATCH in 1 BOX / 9 g in 1 PATCH

Product Details

What are Theracare Medicated Pain Relief Patches Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Theracare Medicated Pain Relief Patches Active Ingredients UNII Codes

Theracare Medicated Pain Relief Patches Inactive Ingredients UNII Codes

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.
  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
  • LIQUID PETROLEUM (UNII: 6ZAE7X688J)
  • STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

* Please review the disclaimer below.

Theracare Medicated Pain Relief Patches Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% .......Topical Analgesic


For External Use Only



Allergy alert: If prone to allergic reaction from asprin or salicylates, consult a doctor before use


Do Not Use:



  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product

When Using This Product



  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tighly
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that keeps product away from childrens and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Consult A Doctor



  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • if symptoms last more than 7 days or clear up and occur again with a few days


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away


Uses



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


Directions



Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.


Inactive Ingredients



Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer


Indication And Usage



For temporary relief of minor aches and pains.


Pain Relief Patch Label




* Please review the disclaimer below.