NDC 72490-004 Nufabrx Compression Sock

Capsaicin

NDC Product Code 72490-004

NDC Code: 72490-004

Proprietary Name: Nufabrx Compression Sock 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: Capsaicin 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.


Code Structure
  • 72490 - Textile-based Delivery, Inc.
    • 72490-004 - Nufabrx Compression Sock

NDC 72490-004-01

Package Description: 2 CLOTH in 1 POUCH

NDC 72490-004-02

Package Description: 2 CLOTH in 1 POUCH

NDC 72490-004-03

Package Description: 2 CLOTH in 1 POUCH

NDC Product Information

Nufabrx Compression Sock with NDC 72490-004 is a a human over the counter drug product labeled by Textile-based Delivery, Inc.. The generic name of Nufabrx Compression Sock is capsaicin. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Textile-based Delivery, Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.


Nufabrx Compression Sock 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.

  • CAPSAICIN .075 1/1

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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

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: Textile-based Delivery, Inc.
Labeler Code: 72490
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: 01-14-2019 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.

Nufabrx Compression Sock Product Label Images

Nufabrx Compression Sock 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 Ingredient

Nonivamide (synthetic capsaicin) 0.075%

Purpose

Topical Analgesic

Uses

  • For simple foot pain, arthritis & strainsUse on bruises & sprains

Warnings

For external use only

Do Not Use

  • On wounds or to damaged skinWith, or at same time as, other analgesic productsAllergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use
  • If pregnant or breastfeeding consult a healthcare professional before use

When Using This Product

  • You may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally diminishes.
  • Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise.Use only as directedAvoid contact with eyes and mucous membranes or rashes

Ask A Doctor Before Use If

  • Your condition worsens, symptoms persist more than 7 days or clear up and occur again within a few daysrash, itching or excessive skin irritation develops

Keep Out Of Reach Of Children.

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

Directions

  • Clean and dry affected areaRemove sock from packaging and place on feetRemove sock after 8 hours of wearWear sock daily, but not more than 4 times per week

Other Information

Avoid storing product in direct sunlight. Protect product from excessive moisture

Inactive Ingredients

WS-23 (synthetic cooling agent)

* Please review the disclaimer below.

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