Coralite Extra Strength Pain Relief Sleeve Wrist
Menthol
United Exchange Corp.
Human Otc Drug
NDC 65923-122Coralite Extra Strength Pain Relief Sleeve Wrist also known as Menthol is a human otc drug labeled by 'United Exchange Corp.'. National Drug Code (NDC) number for Coralite Extra Strength Pain Relief Sleeve Wrist is 65923-122. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Coralite Extra Strength Pain Relief Sleeve Wrist drug includes Menthol - 336 mg/1 . The currest status of Coralite Extra Strength Pain Relief Sleeve Wrist drug is Active.
Drug Information:
| Drug NDC: | 65923-122 |
| 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: | Coralite Extra Strength Pain Relief Sleeve Wrist |
| 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: | United Exchange Corp. |
| 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 - 336 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: | 10 Feb, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| 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, 2023 |
| 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: | United Exchange Corp.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | L7T10EIP3A
|
| 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 |
|---|
| 65923-122-01 | 1 POUCH in 1 BOX (65923-122-01) / 1 PATCH in 1 POUCH | 10 Feb, 2016 | 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:
Uses temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Product Elements:
Coralite extra strength pain relief sleeve wrist menthol carbomer 940 alcohol ethylparaben glycerin propylene glycol water trolamine menthol menthol
Indications and Usage:
Directions adults and children 12 years of age and older: open pouch and remove sleeve remove plastic insert and discard pull sleeve onto wrist, ankle or elbow until the colored (medicated) section of the sleeve is positioned directly over the affected area. sleeve should feel snug, but not tight. note: the drawings should help you understand how to do this. apply one sleeve to affected area no more than 3 times daily do not wear sleeve for more than 8 hours children under 12 years of age: consult a doctor
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly over sleeve or use with a heating pad discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower
Dosage and Administration:
Distributed by: united exchange corp. cypress, ca 90630 usa made in china
Stop Use:
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or irritation or rash develops
Package Label Principal Display Panel:
90122