NDC 11523-0777 Tinactin

Tolnaftate

NDC Product Information

Tinactin with NDC 11523-0777 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Tinactin is tolnaftate. The product's dosage form is aerosol, powder and is administered via topical form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Aerosol, Powder - A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system.

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.

Tinactin 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.

  • TOLNAFTATE 10 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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ISOBUTANE (UNII: BXR49TP611)
  • PPG-12-BUTETH-16 (UNII: 58CG7042J1)
  • 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: Bayer Healthcare Llc.
Labeler Code: 11523
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: 09-23-1993 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".

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Information for Patients

Tolnaftate

Tolnaftate is pronounced as (tole naf' tate)

Why is tolnaftate medication prescribed?
Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm.This medication is sometimes prescribed for other uses;...
[Read More]

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Tinactin Product Label Images

Tinactin 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

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Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)helps prevent most athlete's foot with daily usefor effective relief of itching, burning and cracking

Warnings

For external use onlyFlammable: Do not use while smoking or near heat or flame

When Using This Product

  • Avoid contact with the eyesuse only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop Use And Ask A Doctor If

  • Irritation occursthere is no improvement within 4 weeks

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor.

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

  • 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 condition persists longer, ask a doctorto prevent athlete's foot, apply once or twice daily (morning and/or night)this product is not effective on the scalp or nailsin case of clogging, clean nozzle with pin

Other Information

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Alcohol denat. (11% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16, talc

Questions?

1-866-360-3266

* Please review the disclaimer below.