Pain Relief Cream
Menthol
Sanamax Plus Llc
Human Otc Drug
NDC 72425-201Pain Relief Cream also known as Menthol is a human otc drug labeled by 'Sanamax Plus Llc'. National Drug Code (NDC) number for Pain Relief Cream is 72425-201. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Pain Relief Cream drug includes Menthol - 1.25 g/100g . The currest status of Pain Relief Cream drug is Active.
Drug Information:
| Drug NDC: | 72425-201 |
| 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: | Pain Relief Cream |
| 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: | Sanamax Plus 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 - 1.25 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: | 02 Dec, 2019 |
| 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: | SanaMax Plus LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 416982
|
| 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
|
| 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 |
|---|
| 72425-201-02 | 1 TUBE in 1 BOX (72425-201-02) / 28 g in 1 TUBE | 02 Dec, 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:
Purpose topical analgesic
Product Elements:
Pain relief cream menthol menthol menthol benzyl alcohol cananga odorata flower medium-chain triglycerides caprylyl glycol cetostearyl alcohol chamomile flower oil bergamot oil orange oil crambe hispanica subsp. abyssinica seed oil cymbopogon schoenanthus oil ethylhexylglycerin eucalyptus oil glycerin glyceryl monostearate helichrysum italicum flower oil lavender oil lecithin, sunflower peppermint oil spearmint oil polyoxyl 40 hydrogenated castor oil polyethylene glycol 300 phenoxyethanol pogostemon cablin leaf oil polyglyceryl-3 ricinoleate clary sage oil sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) water
Indications and Usage:
Uses : temporarily relieves the minor aches and pains of muscles and joints associated with: â simple backache â arthritis â strains â bruises â sprains
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
When Using:
When using this product â avoid contact with eyes or mucous membrane â do not bandage tightly
Dosage and Administration:
Directions â use only as directed â adults and children 12 years of age and older: apply to affected area 3 to 4 times daily â children under 12 years of age: ask a doctor before use
Stop Use:
Stop use and ask a doctor if â condition worsens or symptoms persist for more than 7 days â skin irritation occurs
Package Label Principal Display Panel:
Principal display package labeling sanamax plus balanced formula sanamax plus pain relief cream temporary relief from backache, minor arthritis, muscle and joint pain. quick absorbing paraben free non staining non-greasy non-burning fast relief relaxing scent calming effect doctor recommended with 12 essential oils net wt 1 oz (28g) sanamax plus pain relief cream sanamax plus is trusted by medical doctors, pharmacists, physical therapists, chiropractors, massage therapists, podiatrists, and athletic trainers. it applies easily and penetrates quickly for fast temporary relief from sore muscles, backaches, sore joints, and arthritis. sanamax plus is a balanced formula that contains 12 essential oils. it is quick absorbing but is not greasy, does not stain, has a relaxing scent, a calming effect, and does not burn. sanamax plus is not tested on animals, is made in the usa with usp grade ingredients, is free of parabens, and propylene glycol. distributed by: questions or comments sanamax plus llc sanamaxplus.com mcallen, tx 78501 ndc 72425-201-02 8 60473 00240 2 pe 2020/013 ver 01 box tube res sanamax box 201 sanamax tube 201