Fungicure Anti-fungal Wash
Sepia
Denison Pharmaceuticals, Llc.
Human Otc Drug
NDC 0295-2600Fungicure Anti-fungal Wash also known as Sepia is a human otc drug labeled by 'Denison Pharmaceuticals, Llc.'. National Drug Code (NDC) number for Fungicure Anti-fungal Wash is 0295-2600. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Fungicure Anti-fungal Wash drug includes Sepia Officinalis Juice - 12 [hp_X]/mL . The currest status of Fungicure Anti-fungal Wash drug is Active.
Drug Information:
| Drug NDC: | 0295-2600 |
| 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: | Fungicure Anti-fungal Wash |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Fungicure |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Anti-Fungal Wash |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Sepia |
| 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: | Soap |
| 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: | SEPIA OFFICINALIS JUICE - 12 [hp_X]/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: | UNAPPROVED HOMEOPATHIC |
| 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 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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. |
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0072959265069
|
| UPC stands for Universal Product Code. |
| UNII: | QDL83WN8C2
|
| 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 |
|---|
| 0295-2600-23 | 177 mL in 1 TUBE (0295-2600-23) | 01 Jan, 2017 | 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 treatment
Product Elements:
Fungicure anti-fungal wash sepia lauramidopropyl betaine panthenol lecithin, soybean water sodium chloride sodium c14-16 olefin sulfonate tea tree oil sepia officinalis juice sepia officinalis juice
Indications and Usage:
Uses for the treatment of most jock itch (tinea cruris) ringworm (tinea corporis) athlete's foot (tinea pedis) tinea versicolor for relief of: itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with the eyes. if contact occurs rinse thoroughly with water.
Dosage and Administration:
Directions read all package directions and warnings before use. use only as directed. clean the affected area with fungicure anti-fungal wash and warm water, rinse and dry thoroughly. for best results, leave on for 1-2 minutes before rinsing and drying. use twice daily (morning and night), or as directed by a doctor. this product is not effective on scalp or nails. for jock itch, use daily for 2 weeks. for ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. if condition persists longer, consult a doctor. for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. intended for 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. supervise children in the use of this product.
Stop Use:
Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot and tinea versicolor).
Information for Patients:
Other information you may report serious side effects to the phone number provided under questions? below.
Package Label Principal Display Panel:
Fungicure soap
Further Questions:
Questions? 1-800-792-2582