NDC 54312-125 Derman Antifungal

Zinc Undecylenate

NDC Product Code 54312-125

NDC CODE: 54312-125

Proprietary Name: Derman Antifungal What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Zinc Undecylenate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

NDC 54312-125-01

Package Description: 1 TUBE in 1 CARTON > 25 g in 1 TUBE

NDC 54312-125-02

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Derman Antifungal with NDC 54312-125 is a a human over the counter drug product labeled by Compania Internacional De Comercio, S.a.p.i De C.v.. The generic name of Derman Antifungal is zinc undecylenate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Compania Internacional De Comercio, S.a.p.i De C.v.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Derman Antifungal 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 5 g/100g
  • ZINC UNDECYLENATE 18 g/100g

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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
  • POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • SODIUM BISULFITE (UNII: TZX5469Z6I)

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: Compania Internacional De Comercio, S.a.p.i De C.v.
Labeler Code: 54312
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: 08-12-2013 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Derman Antifungal Product Label Images

Derman Antifungal 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 Ingredients.

Zinc undecylenate  18%Undecylenic acid    5%

Purpose

Antifungal

Uses

For the treatment of athletes foot.

Warnings

For external use only

Do Not Use

On children under 12 years of age unless directed by a doctor.

When Using This Product

Avoid contact with the eyes.

Stop Use And Ask A Doctor If

Irritation occurs or if there is no improvement within 4 weeks.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash the affected area and dry thoroughly.Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.Supervise children in the use of this product.For athlete's foot: Pay special attention to between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.Use daily for 4 weeks.If condition persists longer, consult a doctor.This product is not effective on the scalp or nails.

Inactive Ingredients

Cetyl alcohol, Glycerin, Polyethylene glycol 500, Polyethylene glycol 4000, Propylene glycol, Sodium bisulfite, Sodium laureth sulfate, Water, Zinc stearate.

* Please review the disclaimer below.