Proplex Greaseless Muscle Rub
Menthol, Unspecified Form And Methyl Salicylate
Natureplex Llc
Human Otc Drug
NDC 67234-043Proplex Greaseless Muscle Rub also known as Menthol, Unspecified Form And Methyl Salicylate is a human otc drug labeled by 'Natureplex Llc'. National Drug Code (NDC) number for Proplex Greaseless Muscle Rub is 67234-043. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Proplex Greaseless Muscle Rub drug includes Menthol, Unspecified Form - 10 mg/g Methyl Salicylate - 15 mg/g . The currest status of Proplex Greaseless Muscle Rub drug is Active.
Drug Information:
| Drug NDC: | 67234-043 |
| 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: | Proplex Greaseless Muscle Rub |
| 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, Unspecified Form And Methyl Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natureplex Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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, UNSPECIFIED FORM - 10 mg/g
METHYL SALICYLATE - 15 mg/g
|
| 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: | 18 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | Natureplex LLC
|
| 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
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 |
|---|
| 67234-043-01 | 1 TUBE in 1 CARTON (67234-043-01) / 85 g in 1 TUBE | 18 Mar, 2019 | 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:
Purposes topical analgesic topical analgesic
Product Elements:
Proplex greaseless muscle rub menthol, unspecified form and methyl salicylate menthol, unspecified form menthol, unspecified form methyl salicylate salicylic acid carbomer copolymer type a (allyl pentaerythritol crosslinked) cetyl alcohol glycerin glyceryl monostearate isopropyl palmitate methylparaben potassium cetyl phosphate propylparaben water stearic acid stearyl alcohol trolamine
Indications and Usage:
Use temporarily relieves minor aches and pains of muscles and joints
Warnings:
Warnings for external use only. avoid contact with eyes and mucus membranes. not for prolonged use. do not use than otherwise directed on wounds or damaged skin a bandage tightly stop use and ask a physician if rash or excessive irritation of the skin develops condition worsens or symptoms persist for more than 7 days condition clears up and occurs again within a few days 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: 800-222-1222.
Do Not Use:
Warnings for external use only. avoid contact with eyes and mucus membranes. not for prolonged use. do not use than otherwise directed on wounds or damaged skin a bandage tightly stop use and ask a physician if rash or excessive irritation of the skin develops condition worsens or symptoms persist for more than 7 days condition clears up and occurs again within a few days 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: 800-222-1222.
Dosage and Administration:
Directions adults and children 2 years of age and older: apply to affected area 3 to 4 times daily children under 2 years of age: consult a physician
Stop Use:
Stop use and ask a physician if rash or excessive irritation of the skin develops condition worsens or symptoms persist for more than 7 days condition clears up and occurs again within a few days
Package Label Principal Display Panel:
Principal display panel - 85 g tube carton ndc # 67234-043-01 greaseless muscle rub menthol 10% methyl salicylate 15% temporarily relieves minor aches and pains associated with: - simple backache - arthritis - muscle strains - bruises net wt. 3 oz (85 g) pro plex principal display panel - 85 g tube carton
Further Questions:
Questions or comments? 866-323-0107 or www.natureplex.com