Funginix Anti-fungal Treatment
Undecylenic Acid
The Sisquoc Healthcare Corporation
Human Otc Drug
NDC 71229-102Funginix Anti-fungal Treatment also known as Undecylenic Acid is a human otc drug labeled by 'The Sisquoc Healthcare Corporation'. National Drug Code (NDC) number for Funginix Anti-fungal Treatment is 71229-102. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Funginix Anti-fungal Treatment drug includes Undecylenic Acid - 10 g/100mL . The currest status of Funginix Anti-fungal Treatment drug is Active.
Drug Information:
| Drug NDC: | 71229-102 |
| 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: | Funginix Anti-fungal 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: | Undecylenic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Sisquoc Healthcare Corporation |
| 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: | UNDECYLENIC ACID - 10 g/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: | 25 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | The Sisquoc Healthcare Corporation
|
| 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. |
| 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 |
|---|
| 71229-102-11 | 30 mL in 1 TUBE (71229-102-11) | 25 Mar, 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 antifungal
Product Elements:
Funginix anti-fungal treatment undecylenic acid undecylenic acid undecylenic acid water almond oil oleth-10 phosphate trolamine polysorbate 20 butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) glycerin propylene glycol arctostaphylos uva-ursi whole oat propolis wax aloe vera leaf .alpha.-tocopherol acetate camphor oil menthol tea tree oil lavender oil jasminum officinale whole clove oil cocoa butter rosa canina flower oil cetyl hydroxyethylcellulose (350000 mw) phenoxyethanol ethylhexylglycerin
Indications and Usage:
Uses anti-fungal treatment
Warnings:
Warnings for external use only. do not use on children under 2 years of age unless directed by a doctor. when using this product avoid contact with the eyes. if contact occurs, rinse the eyes very thoroughly with water. stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.
Dosage and Administration:
Directions for the cure of most ringworm (tinea corporis) and athleteâs foot (tinea pedis). for relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions. clean the affected area with soap and warm water and dry thoroughly. apply a thin layer of funginix over the affected area twice daily (morning and night), or as directed by a physician. allow 3-5 minutes for the solution to penetrate the skin and absorb fully into the surrounding tissue. funginix should be applied to cuticles, around nail edges and under nail tips where reachable with the applicator brush. this product is not intended to, nor will it, penetrate hard nail surfaces. for athleteâs foot, pay special attention to spaces between toes; wear well ôitting, ventilated shoes and change shoes and socks at least once daily. for athleteâs foot and ringworm, use daily for 4 weeks. if condition persists longer, consult a doctor. intended f
Read more...or use by normally healthy adults only. persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
Package Label Principal Display Panel:
Funginix label funginix insert