NDC 21130-213 Tolnaftate

Antifungal Liquid Spray

NDC Product Code 21130-213

NDC 21130-213-00

Package Description: 150 g in 1 CANISTER

NDC Product Information

Tolnaftate with NDC 21130-213 is a a human over the counter drug product labeled by Better Living Brands Llc. The generic name of Tolnaftate is antifungal liquid spray. The product's dosage form is aerosol, spray and is administered via topical form.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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)

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: Better Living Brands Llc
Labeler Code: 21130
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: 09-27-2021 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 athlete's foot (tinea pedis) and ringworm (tinea corporis)prevent recurrence of most athlete's foot with daily usefor effective relief of itching, burning and cracking

Warnings

For external use only.

​Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.

When Using This Product

  • Avoid contact with the eyes or mouthuse only as directed

Stop Use And Ask A Doctor If

  • Irritation occursno improvement within four weeks (for athlete's foot) or two weeks (for jock itch)

Keep Out Of Reach Of Children.

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








Do not use on children under two years of age unless directed by a doctor.

Directions

  • Wash affected area and dry thoroughlyshake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this productfor athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once dailyuse daily for 4 weeks if conditions persist, consult a doctorto prevent athlete's foot, appl morning and/or nightthis product is not effective on the scalp or nailsif nozzle clogs, clear under running water

​Other Information

Store between 20º and 30ºC (68ºF and 86º)

​Inactive Ingredients

BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B

​Questions?

Call 1-866-964-0939

* Please review the disclaimer below.