NDC 63941-555 Tolnaftate

Tolnaftate Athletes Foot Powder Spray

NDC Product Code 63941-555

NDC 63941-555-46

Package Description: 130 g in 1 CAN

NDC Product Information

Tolnaftate with NDC 63941-555 is a a human over the counter drug product labeled by Valu Merchandisers, Co. The generic name of Tolnaftate is tolnaftate athletes foot powder spray. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 705934.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Tolnaftate 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.


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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ISOBUTANE (UNII: BXR49TP611)
  • PPG-12-BUTETH-16 (UNII: 58CG7042J1)
  • ALCOHOL (UNII: 3K9958V90M)
  • TALC (UNII: 7SEV7J4R1U)

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: Valu Merchandisers, Co
Labeler Code: 63941
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: 12-12-2017 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: 12-31-2022 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.

Tolnaftate 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

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of most
  • Athlete’s foot (tinea pedis)
  • Ringworm (tinea corporis)
  • Effectively soothes and relieves
  • Itching
  • Burning
  • Cracking
  • Helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only Flammable: Do not use near flame or spark or while smoking.

Do Not Use

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

When Using This Product

  • Avoid contact with the eyes
  • Contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop Use And Ask A Doctor If

  • Irritation occurs
  • 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

  • Clean the affected area and dry thoroughly
  • Shake can well before use
  • Hold can about 6 inches from the area to be treated
  • Spray a thin layer over the affected area twice daily (morning and night)
  • Supervise children in the use of this product
  • 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.
  • Use daily for 4 weeks. If condition lasts longer, ask a doctor.
  • To prevent athlete’s foot, apply to the feet once or twice daily (morning and/or night)
  • This product is not effective on the scalp or nails
  • In case of clogging, clean nozzle with a pin

Inactive Ingredients

Alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

* Please review the disclaimer below.