NDC 36800-754 Topcare Antifungal Maximum Strength

Undecylenic Acid

NDC Product Code 36800-754

NDC 36800-754-01

Package Description: 30 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Topcare Antifungal Maximum Strength with NDC 36800-754 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Antifungal Maximum Strength is undecylenic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Topco Associates 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.


Topcare Antifungal Maximum Strength 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 25 mg/30mL

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: Topco Associates Llc
Labeler Code: 36800
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: 04-22-2019 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.

Topcare Antifungal Maximum Strength Product Label Images

Topcare Antifungal Maximum Strength 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%

​Purpose

Anti-fungal

Uses

  • ▪Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)▪For effective relief of itching, burning and cracking.

Warnings

For external use only

Do Not Use

On children 2 years of age unless directed by a doctor.

When Using This Product

  • ▪avoid contact with eyes

Stop Use And Consult A Doctor If

  • ▪there is no improvement within 4 weeks▪irritation occurs

Keep This And All Medication Out Of Reach Of Children.

If case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice at 1-800-222-1222.

​Directions

  • Read all warnings and directions. Use only as directed.▪clean the affected area with soap and warm water and dry thoroughly▪Apply a thin layer of Anti-Fungal liquid 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 athlete's foot: pay special attention to spaces between toes▪For athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor ▪this product is not effective on the scalp or nails▪Supervise children in the use of this product

Other Information

  • •store at room temperature 15°-30°C (59° - 86°F) •protect from freezing. If freezing occurs warm to room temperature

​Inactive Ingredient

Isopropyl palmitate

Questions?

Call 1-888-423-0139

* Please review the disclaimer below.

Previous Code
36800-753
Next Code
36800-756