NDC 67510-0287 Soundbody Cold And Hot Pain Relief

Menthol

NDC Product Code 67510-0287

NDC 67510-0287-2

Package Description: 2 PATCH in 1 POUCH

NDC Product Information

Soundbody Cold And Hot Pain Relief with NDC 67510-0287 is a a human over the counter drug product labeled by Kareway Product, Inc.. The generic name of Soundbody Cold And Hot Pain Relief is menthol. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 420222.

Dosage Form: Patch - 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’.

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.

Soundbody Cold And Hot Pain Relief 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.

  • POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POVIDONES (UNII: FZ989GH94E)

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: Kareway Product, Inc.
Labeler Code: 67510
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: 05-11-2018 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 - 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.

Soundbody Cold And Hot Pain Relief Product Label Images

Soundbody Cold And Hot Pain Relief 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

Menthol 5%

Purpose

Topical analgesic

Uses

  • Temporarily relieves minor pain associated with:arthritismuscle strainssimple backachebursitiscrampstendonitismuscle sprainsbruises

Warnings

For external use only

When Using This Product

  • Use only as directeddo not bandage tightlydo not use a heating padavoid contact with eyes and mucous membranedo not apply to wounds or damaged skindo not use if you are allergic to any ingredients of this product

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysredness is presentirritation develops

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children over 12 years:Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middleCarefully remove backing from patchApply one patch to affected areaRepeat as necessary, but no more than 4 times dailyChildren under 12 years of age: Ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

Aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide

Package Label

Cold and Hot Pain Relief Patch

* Please review the disclaimer below.