Tolcylen Antifungal Solution
Tolnaftate
Marlinz Pharma, Llc
Human Otc Drug
NDC 70945-100Tolcylen Antifungal Solution also known as Tolnaftate is a human otc drug labeled by 'Marlinz Pharma, Llc'. National Drug Code (NDC) number for Tolcylen Antifungal Solution is 70945-100. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Tolcylen Antifungal Solution drug includes Tolnaftate - 1 mg/100mL . The currest status of Tolcylen Antifungal Solution drug is Active.
Drug Information:
| Drug NDC: | 70945-100 |
| 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: | Tolcylen Antifungal Solution |
| 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: | Tolnaftate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Marlinz Pharma, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | TOLNAFTATE - 1 mg/100mL
|
| 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 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: | 16 Dec, 2016 |
| 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. |
| Application Number: | part333C |
| 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: | Marlinz Pharma, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313423
1988416
|
| 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: | 06KB629TKV
|
| 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 |
|---|
| 70945-100-75 | 1 TUBE, WITH APPLICATOR in 1 CARTON (70945-100-75) / 7.5 mL in 1 TUBE, WITH APPLICATOR | 16 Dec, 2016 | 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:
Tolcylen antifungal solution tolnaftate dimethyl isosorbide isopropyl alcohol isopropyl myristate lactic acid ethyl acetate urea undecylenic acid propylene glycol jojoba oil tolnaftate tolnaftate clear fluid
Indications and Usage:
Uses cures most athleteâs foot (tinea pedis) â relieves itching, cracking, burning and scaling, which accompanies this condition â prevents recurrence of athleteâs foot
Warnings:
Warnings do not use on children under 2 years of age â for external use only â avoid contact with the eyes. if eye contact occurs, wash thoroughly with water â stop use and consult a physician if irritation occurs or if there is no improvement within four (4) weeks â keep out of reach of children â if swallowed, get medical help or contact a poison control center right away â if pregnant or breast-feeding, ask a health-care professional before use.
Dosage and Administration:
Directions wash the affected area with soap and water. â dry thoroughly, then apply a thin layer over the affected area. â use twice daily (morning and night) or as directed by a physician. â pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails. â wear well-fitted ventilated shoes and change socks at least once daily. â use daily for four (4) weeks. if condition persists longer, consult a physician. â wash hands after each use. store and use at room temperature.
Package Label Principal Display Panel:
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