Medipap Cool
L-menthol
Cho-a Pharm.co.,ltd.
Human Otc Drug
NDC 58354-107Medipap Cool also known as L-menthol is a human otc drug labeled by 'Cho-a Pharm.co.,ltd.'. National Drug Code (NDC) number for Medipap Cool is 58354-107. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Medipap Cool drug includes Levomenthol - 20 mg/11.7g . The currest status of Medipap Cool drug is Active.
Drug Information:
| Drug NDC: | 58354-107 |
| 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: | Medipap Cool |
| 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: | L-menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cho-a Pharm.co.,ltd. |
| 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: | LEVOMENTHOL - 20 mg/11.7g
|
| 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: | UNAPPROVED DRUG OTHER |
| 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, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| 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: | Cho-A Pharm.Co.,Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1999889
|
| 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: | BZ1R15MTK7
|
| 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 |
|---|
| 58354-107-02 | 5 PATCH in 1 POUCH (58354-107-02) / 11.7 g in 1 PATCH (58354-107-01) | 21 Feb, 2018 | 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 external analgesic
Product Elements:
Medipap cool l-menthol felbinac propylparaben diisopropanolamine titanium dioxide carboxymethylcellulose sodium (0.7 carboxymethyl substitution per saccharide; 1200 mpa.s at 1%) sodium polyacrylate (2500000 mw) tartaric acid butylated hydroxytoluene methylparaben dipropylene glycol levomenthol levomenthol propylene glycol monolaurate kaolin gelatin water
Indications and Usage:
Uses for the temporarily relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains
Warnings:
Warnings for external use only do not use on wounds or damaged skin if you are allergic to any ingredients of this product with a heating pad with, or at the same time as, other external analgesic products when using this product do not use otherwise than directed avoid contact with eyes, mucous membranes or rashes do not bandage tightly ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates stop use and ask a doctor if rash, itching, or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days keep out of reach of children . if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away. if pregnant or breast-feeding, ask a health professional before use.
Dosage and Administration:
Directions adults and children 12 years of age and over: clean and dry affected area remove patch from film apply to affected area no more than 3 to 4 times daily for 7 days remove patch from skin after at most 8 hoursâ application children undress 12 years of age: consult a doctor
Package Label Principal Display Panel:
Medipap cool medical cool