Treatonic Nail Fungus Treatment
Nail Fungus Treatment
Shenzhen Situya Trading Co., Ltd.
Human Otc Drug
NDC 82739-001Treatonic Nail Fungus Treatment also known as Nail Fungus Treatment is a human otc drug labeled by 'Shenzhen Situya Trading Co., Ltd.'. National Drug Code (NDC) number for Treatonic Nail Fungus Treatment is 82739-001. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Treatonic Nail Fungus Treatment drug includes Miconazole Nitrate - 2 mg/100mL . The currest status of Treatonic Nail Fungus Treatment drug is Active.
Drug Information:
| Drug NDC: | 82739-001 |
| 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: | Treatonic Nail Fungus Treatment |
| 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: | Nail Fungus Treatment |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Shenzhen Situya Trading Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | MICONAZOLE NITRATE - 2 mg/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | EXTRACORPOREAL
|
| 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: | 19 May, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 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: | Shenzhen Situya Trading Co., Ltd.
|
| 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: | 0731299873494
|
| UPC stands for Universal Product Code. |
| UNII: | VW4H1CYW1K
|
| 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. |
| Pharmacologic Class: | Azole Antifungal [EPC]
Azoles [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82739-001-01 | 3 mL in 1 BOX (82739-001-01) | 19 May, 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 antifungal
Product Elements:
Treatonic nail fungus treatment nail fungus treatment water alcohol chlorhexidine acetate laurocapram chitin salicylic acid propylene glycol xanthan gum 4-hydroxybenzyl alcohol acetic acid angelica sinensis root angelica dahurica leaf miconazole nitrate miconazole
Indications and Usage:
Uses proven effective in the treatment of mostathlete s foot (tinea pedis) and tinea corporis (ringworm). for effective relief of itching, burning, and cracking.
Warnings:
Warnings for external use only . if pregnant or breastfeeding consult a healthcareprofessional before use
Do Not Use:
Warnings for external use only . if pregnant or breastfeeding consult a healthcareprofessional before use
When Using:
When using this product avoid contact with the eyes . ifeyes contact occurs , rinse thoroughly with water .
Dosage and Administration:
Directions directions use only as directedadults and children 12 years and older: thoroughlyash and dry the affected areas gently rotate the endof the pen (around 10s) to dispense the product onto thebrush applicator. apply a thin layer of liquid directlyover affected areas and surrounding cuticle areas 2times (morning and night) daily or as directed by a doctor. depending on the condition of the affected area , use itdaily for 2-4 weeks children under 12 years: ask a doctor
Stop Use:
Stop use stop use and consult a doctor if irritation occurs. there is no improvement within 4 weeks.
Package Label Principal Display Panel:
Package label-principal display panel 82739-001-01