NDC 0363-0186 Tolnaftate

Anti-fungal Liquid Maximum Strength

NDC Product Code 0363-0186

NDC 0363-0186-30

Package Description: 30 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Tolnaftate with NDC 0363-0186 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Tolnaftate is anti-fungal liquid maximum strength. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Walgreen Company

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.

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.

  • TOLNAFTATE .3 g/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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Walgreen Company
Labeler Code: 0363
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: 03-24-2021 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% w/w

​Purpose

Antifungal

Uses

Proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corportis)prevents the recurrences of athlete's foot with daily usefor effective relief of itching, burning, cracking, redness and scaling

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

  • Irritation occursthere is no improvement in 4 weeks

Keep Out Of Reach Of Children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

​Directions

  • Read all warnings and directions. Use only as directed.clean the affected area and dry thoroughlyapply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between toeswear well-fitting, ventilated shoes, and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeks.If condition persists longer, consult a doctorto prevent athlete's foot: wash the feet thoroughly, apply a thin layer of the product to the feet once or twice daily (morning and/or night)this product is not effective on the scalp or nails

​Other Information​

  • Store at room temperature 15°-30°C (59° - 86°F)protect from freezing. If freezing occurs warm to room temperaturekeep tightly closed when not in use

​Inactive Ingredient

Water, Acrylates Copolymer, Glycerin (RSPO). Phenoxyethanol, Tocopherol, Sodium Hydroxide, Ethylhexyglycerin

Questions?

Call 1-866-964-0939

Principal Display

  • WalgreensAntifungalLiquidTOLNAFTATE 1%MAXIMUM STRENGTHMEDICATEDANTIFUNGALProven clinically effective in the cure & prevention of fungus on fingers, toes & around nailsRelieves itching, burning & scalingWith moisturizerBuilt-in brush for easy applicationNET WT 1 FL OZ(30 mL)

* Please review the disclaimer below.