Bio Healing
Schorl Tourmaline, Menthol
Charmguru
Human Otc Drug
NDC 82541-020Bio Healing also known as Schorl Tourmaline, Menthol is a human otc drug labeled by 'Charmguru'. National Drug Code (NDC) number for Bio Healing is 82541-020. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Bio Healing drug includes Menthol - .05 mg/100mg Schorl Tourmaline - 9 mg/100mg . The currest status of Bio Healing drug is Active.
Drug Information:
| Drug NDC: | 82541-020 |
| 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: | Bio Healing |
| 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: | Schorl Tourmaline, Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Charmguru |
| 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: | MENTHOL - .05 mg/100mg
SCHORL TOURMALINE - 9 mg/100mg
|
| 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: | 01 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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. |
| 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: | CharmGURU
|
| 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. |
| UPC: | 8809484040029
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
173O8XLY6T
|
| 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 |
|---|
| 82541-020-02 | 24 PATCH in 1 CARTON (82541-020-02) / 35.35 mg in 1 PATCH (82541-020-01) | 01 Oct, 2022 | N/A | No |
| 82541-020-04 | 12 PATCH in 1 CARTON (82541-020-04) / 79.2 mg in 1 PATCH (82541-020-03) | 01 Oct, 2022 | N/A | No |
| 82541-020-06 | 12 PATCH in 1 CARTON (82541-020-06) / 252.9 mg in 1 PATCH (82541-020-05) | 01 Oct, 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
Product Elements:
Bio healing schorl tourmaline, menthol schorl tourmaline schorl tourmaline menthol menthol capsicum oleoresin 1,2-hexanediol artemisia princeps whole germanium dioxide glycerin
Indications and Usage:
Uses for relief of aches and pains of muscles and joints associated with: â arthritis â bruises â sprains â spasm â frozen shoulder â menstrual pain â itchy with insect bites
Warnings:
Warnings for external use only -------------------------------------------------------------------------------------------------------- do not use â on wounds or damaged skin (can use in case of slight) -------------------------------------------------------------------------------------------------------- ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients -------------------------------------------------------------------------------------------------------- when using this product â use only as directed â read and follow all directions and warnings on this label â do not allow contact with the eyes and mucous membranes or rashes â discontinue use during hot steam baths -------------------------------------------------------------------------------------------------------- stop use and ask a doctor if â condition worsens â rash, itching or excessive skin irritation develops
Dosage and Administration:
Directions adult and children 12 years of age and over: â clean and dry affected area â peel film from patch and apply to the skin (see illustration) â suggested duration of use for patch is 24 hours children under 12 years of age: under the protection of parents people with weak skin: consult a physician
Package Label Principal Display Panel:
Ndc# 82541-020-02: small size 24pcs (each 35.35mg)ndc# 82541-020-04: medium size 12pcs (each 79.20mg) ndc# 82541-020-06: large size 12pcs (each 252.90mg) image of carton
Further Questions:
Questions â phone: +82-50-5233-7942, â whatsapp: +82-10-4056-6761