Cold And Hot Pain Relief
Menthol
Kareway Product, Inc.
Human Otc Drug
NDC 67510-0300Cold And Hot Pain Relief also known as Menthol is a human otc drug labeled by 'Kareway Product, Inc.'. National Drug Code (NDC) number for Cold And Hot Pain Relief is 67510-0300. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Cold And Hot Pain Relief drug includes Menthol - 400 mg/1 . The currest status of Cold And Hot Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 67510-0300 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cold And Hot Pain Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kareway Product, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MENTHOL - 400 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 21 Feb, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 67510-0300-2 | 1 POUCH in 1 CARTON (67510-0300-2) / 2 PATCH in 1 POUCH | 21 Feb, 2017 | N/A | No |
| 67510-0300-3 | 1 POUCH in 1 CARTON (67510-0300-3) / 3 PATCH in 1 POUCH | 21 Feb, 2017 | N/A | No |
| 67510-0300-4 | 1 POUCH in 1 CARTON (67510-0300-4) / 4 PATCH in 1 POUCH | 21 Feb, 2017 | N/A | No |
| 67510-0300-5 | 1 POUCH in 1 CARTON (67510-0300-5) / 5 PATCH in 1 POUCH | 21 Feb, 2017 | N/A | No |
| 67510-0300-6 | 1 POUCH in 1 CARTON (67510-0300-6) / 6 PATCH in 1 POUCH | 21 Feb, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Cold and hot pain relief menthol glycerin polysorbate 80 sodium polyacrylate (8000 mw) methylparaben propylparaben water tartaric acid titanium dioxide dihydroxyaluminum aminoacetate kaolin menthol menthol polyacrylic acid (250000 mw) povidone polyethylene glycol 400 carboxymethylcellulose mineral oil petrolatum
Indications and Usage:
Uses temporarily relieves minor pain associated with: arthritis muscle strains simple backache bursitis cramps tendonitis muscle sprains bruises
Warnings:
Warnings for external use only when using this product use only as directed do not bandage tightly do not use a heating pad avoid contact with eyes and mucous membrane do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this product stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation 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.
When Using:
When using this product use only as directed do not bandage tightly do not use a heating pad avoid contact with eyes and mucous membrane do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this product
Dosage and Administration:
Directions adults and children over 12 years: remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle carefully remove backing from patch apply one patch to affected area repeat as necessary, but no more than 4 times daily children under 12 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops
Package Label Principal Display Panel:
Package label cold and hot pain relief patch carton