Painxit
Methyl Salicylate, Menthol
Asclemed Usa, Inc
Human Otc Drug
NDC 76420-211Painxit also known as Methyl Salicylate, Menthol is a human otc drug labeled by 'Asclemed Usa, Inc'. National Drug Code (NDC) number for Painxit is 76420-211. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Painxit drug includes Menthol - 3 g/100g Methyl Salicylate - 10 g/100g . The currest status of Painxit drug is Active.
Drug Information:
| Drug NDC: | 76420-211 |
| 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: | Painxit |
| 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: | Methyl Salicylate, Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Asclemed Usa, Inc |
| 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 - 3 g/100g
METHYL SALICYLATE - 10 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: | 28 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Asclemed USA, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1486874
|
| 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. |
| UPC: | 0376420211013
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 76420-211-01 | 113.4 g in 1 BOTTLE (76420-211-01) | 28 Sep, 2022 | 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 topical analgesic
Product Elements:
Painxit methyl salicylate, menthol carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf water cetyl alcohol diazolidinyl urea isopropyl myristate methylparaben polyethylene glycol 400 propylparaben propylene glycol sodium lauryl sulfate trolamine methyl salicylate salicylic acid menthol menthol
Indications and Usage:
Uses for temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.
Warnings:
Warning for external use only. avoid contact with eyes and mucous membranes. do not bandage tightly or cover treated areas. do not use with heating pad. do not apply to open wounds or damages skin. a mild burning sensation may occur. if severe burning sensation occurs, discontinue use immediately. if symptoms persist for more than seven days, discontinue use and consult physician. keep out of reach of children. if swallowed, consult physician. if pregnant or breast feeding, contact physician prior to use.
Dosage and Administration:
Directions for adults apply directly to affected area. repeat as necessary, but do not use more than 3-4 times daily.
Package Label Principal Display Panel:
Principal display panel ndc 76420-211-01 painxit pain relief cream 4 oz (113.4g) distributed by: enovachem pharmaceuticals torrance, ca 90501 (310) 320-0100 image description