NDC 79481-0015 Antifungal Cream Tolnaftate 1%

Tolnaftate

NDC Product Information

Antifungal Cream Tolnaftate 1% with NDC 79481-0015 is a a human over the counter drug product labeled by Meijer. The generic name of Antifungal Cream Tolnaftate 1% is tolnaftate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Meijer

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.

Antifungal Cream Tolnaftate 1% 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 1 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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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: Meijer
Labeler Code: 79481
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: 05-12-2021 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.

Antifungal Cream Tolnaftate 1% Product Label Images

Antifungal Cream Tolnaftate 1% 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 use ● for effective relief of itching, burning and cracking.

Warnings

For external use only.

When Using This Product

Avoid contact with the eyes

Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Stop Use And Ask A Doctor If

  • Stop use and ask a doctor if irritation occursthere is no improvement within 4 weeks

If Pregnant Or Breast-Feeding

If Pregnant or Breast-feeding ask a health professional before use

Inactive Ingredients

Cetostearyl alcohol, ethylparaben, glycerol, mineral oil, glyceryl monostearate, petrolatum, purified water, sodium lauryl sulfate

Directions

● wash affected area and dry thoroughly● apply a thin layer 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 spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.● for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult doctor. ● to prevent athlete's foot, apply once or twice daily (morning and/or night)● this product is not effective on the scalp or nails.

Other Information

● store between 20° to 25°C ( 68° to 77°F)

Distributed By

Distrubuted By Meijer Distribution, Inc.Grand Rapids, MI 49544www.meijer.comMade in ChinaThis product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademarks Tough Actin and Tinactin.

* Please review the disclaimer below.