Kinesys Analgesic Sport
Methyl Salicylate And Menthol
Wilc Healthcare Inc
Human Otc Drug
NDC 61481-0020Kinesys Analgesic Sport also known as Methyl Salicylate And Menthol is a human otc drug labeled by 'Wilc Healthcare Inc'. National Drug Code (NDC) number for Kinesys Analgesic Sport is 61481-0020. This drug is available in dosage form of Stick. The names of the active, medicinal ingredients in Kinesys Analgesic Sport drug includes Menthol - 15 g/100g Methyl Salicylate - 30 g/100g . The currest status of Kinesys Analgesic Sport drug is Active.
Drug Information:
| Drug NDC: | 61481-0020 |
| 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: | Kinesys Analgesic Sport |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Kinesys |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Analgesic Sport |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Methyl Salicylate And Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wilc Healthcare Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Stick |
| 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 - 15 g/100g
METHYL SALICYLATE - 30 g/100g
|
| 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: | 31 May, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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, 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: | Wilc Healthcare Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1100684
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | L7T10EIP3A
LAV5U5022Y
|
| 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 |
|---|
| 61481-0020-1 | 50 g in 1 CYLINDER (61481-0020-1) | 31 May, 2012 | 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:
Duration of use consult a health care practitioner for use beyond 7 days.
Product Elements:
Kinesys analgesic sport methyl salicylate and menthol methyl salicylate salicylic acid menthol menthol propylene glycol polyethylene glycol 400 alcohol sodium stearate water d&c green no. 5
Indications and Usage:
Recommended use temporarily relieves aches and pains of muscles and joints associated with one or more of the following: backache, strains and sprains (involving muscles, tendons, and/or ligaments), and arthritis.
Warnings:
Cautions and warnings keep out of the reach of children. if overdose or accidental ingestion occurs, call a poison control center immediately. discontinue use and consult a health care practitioner if symptoms persist and/or worsen after 7 days or re-occur within a few days. consult a healthcare practitioner prior to use if you are pregnant or breastfeeding . consult a healthcare practitioner prior to use if you are taking anticoagulant medications. store protected from direct light and moisture at room temperature.
When Using:
If overdose or accidental ingestion occurs, call a poison control center immediately.
Dosage and Administration:
Recommended dose adults, adolescents 1-4 time(s) per day. apply thinly and evenly to affected area up to 3 to 4 times per day. rub and/or massage into skin until solution vanishes. for external use only. avoid contact with the eyes and mucous membranes. do not apply to wounds or damaged skin. do not tightly bandage. do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn. children 2-12 years old 1-4 time(s) per day. application should be supervised by an adult. apply thinly and evenly to affected area up to 3 to 4 times per day. rub and/or massage into skin until solution vanishes. for external use only. avoid contact with the eyes and mucous membranes. do not apply to wounds or damaged skin. do not tightly bandage. do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.
Stop Use:
Discontinue use and consult a health care practitioner if symptoms persist and/or worsen after 7 days or re-occur within a few days.
Package Label Principal Display Panel:
Principal display panel - 50 g cylinder label kin e sys ® analgesic sport stick penetrating warm pain relief for muscular and arthritic discomfort extra strength muscle care topical hands-free applicator 50 g (1.76 oz) npn 80029329 principal display panel - 50 g cylinder label