NDC 0295-9810 Fungicure Anti-fungal Liquid 25%

Undecylenic Acid

NDC Product Code 0295-9810

NDC 0295-9810-05

Package Description: 28 g in 1 TUBE, WITH APPLICATOR

NDC 0295-9810-10

Package Description: 38 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Fungicure Anti-fungal Liquid 25% with NDC 0295-9810 is a a human over the counter drug product labeled by Denison Pharmaceuticals Llc. The generic name of Fungicure Anti-fungal Liquid 25% is undecylenic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Denison Pharmaceuticals Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fungicure Anti-fungal Liquid 25% Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • UNDECYLENIC ACID 250 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Denison Pharmaceuticals Llc
Labeler Code: 0295
FDA Application Number: part333C What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-20-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fungicure Anti-fungal Liquid 25% Product Label Images

Fungicure Anti-fungal Liquid 25% Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Undecylenic acid 25% w/w

Purpose

Antifungal

Uses

  • For the cure of mostringworm (tinea corporitis) and athlete's foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts which may accompany these conditions.

Warnings

For external use only.

Otc - Ask Doctor

Ask a doctor before use on children under 2 years of age.

Otc - When Using

When using this product avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • Irritation occursThere is no improvement within 4 weeks.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Directions

Read all package directions and warnings before use.

Use only as directed.

Clean the affected area with soap and warm water and dry thoroughly.

Apply a thin layer of FUNGICURE Liquid over the affected area twice daily (morning and night), or as directed by a doctor.

This product is not effective on scalp or nails.

For ringworm and athlete's foot, use daily for 4 weeks.

For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.

If condition persists longer, consult a doctor.

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.

Other Information

  • FUNGICURE may be applied to exposed nail beds, cuticles, around nail edges and under nail tips where reachable with its applicator brush.This product is not intended to, nor will it, penetrate hard nail surfaces.While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained.You may report serious side effects to the phone number provided under
  • Questions? below.

Inactive Ingredients

Isopropyl palmitate

Otc - Questions

Questions? 1-800-792-2582

* Please review the disclaimer below.

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