Fungi Nail Toe And Foot Anti-fungal
Undecylenic Acid
Denison Pharmaceuticals, Llc.
Human Otc Drug
NDC 0295-9032Fungi Nail Toe And Foot Anti-fungal also known as Undecylenic Acid is a human otc drug labeled by 'Denison Pharmaceuticals, Llc.'. National Drug Code (NDC) number for Fungi Nail Toe And Foot Anti-fungal is 0295-9032. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Fungi Nail Toe And Foot Anti-fungal drug includes Undecylenic Acid - 250 mg/mL . The currest status of Fungi Nail Toe And Foot Anti-fungal drug is Active.
Drug Information:
| Drug NDC: | 0295-9032 |
| 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: | Fungi Nail Toe And Foot Anti-fungal |
| 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: | Undecylenic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Denison Pharmaceuticals, 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: | UNDECYLENIC ACID - 250 mg/mL
|
| 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: | 06 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | 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: | Denison Pharmaceuticals, LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998329
|
| 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: | 0000000657389
|
| UPC stands for Universal Product Code. |
| UNII: | K3D86KJ24N
|
| 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 |
|---|
| 0295-9032-05 | 1 BOTTLE in 1 CARTON (0295-9032-05) / 30 mL in 1 BOTTLE | 06 Feb, 2019 | N/A | No |
| 0295-9032-11 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0295-9032-11) / 1.7 mL in 1 TUBE, WITH APPLICATOR | 06 Feb, 2019 | N/A | No |
| 0295-9032-16 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0295-9032-16) / 3 mL in 1 TUBE, WITH APPLICATOR | 06 Feb, 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:
Active ingredient....................purpose undecylenic acid.....................anti-fungal
Product Elements:
Fungi nail toe and foot anti-fungal undecylenic acid undecylenic acid undecylenic acid isopropyl palmitate
Indications and Usage:
Uses ? proven effective in the treatment of most athletes foot (tinea pedis) and ringworm (tinea corporis). ? for effective relief of itching, burning and cracking.
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
When Using:
When using this product ? avoid contact with eyes.
Dosage and Administration:
Directions ? clean affected areas with soap and warm water and dry thoroughly. ? apply a thin layer of fungi-nail ® toe & foot ® anti-fungal solution over affected area twice daily (morning and night) or as directed by a doctor. ? the brush applicator allows for easy application under nails and surrounding cuticle area. ? wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ? for athletes foot pay special attention to spaces between the toes. ? for athletes foot and ringworm, use daily for 4 weeks. ? this product is not effective on the scalp or nails. ? supervise children in the use of this product.
Stop Use:
Stop use and ask a doctor if ? irritation occurs. ? there is no improvement within 4 weeks.
Package Label Principal Display Panel:
Label