NDC 0536-1329 Rugby Tolnaftate 1% Powder

Rugby Tolnaftate 1% Powder

NDC Product Code 0536-1329

NDC CODE: 0536-1329

Proprietary Name: Rugby Tolnaftate 1% Powder What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Rugby Tolnaftate 1% Powder What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 0536 - Rugby Laboratories

NDC 0536-1329-26

Package Description: 24 BOTTLE, PLASTIC in 1 CASE > 45 g in 1 BOTTLE, PLASTIC

NDC Product Information

Rugby Tolnaftate 1% Powder with NDC 0536-1329 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Rugby Tolnaftate 1% Powder is rugby tolnaftate 1% powder. The product's dosage form is powder and is administered via topical form.

Labeler Name: Rugby Laboratories

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Rugby Tolnaftate 1% Powder 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.

  • TALC (UNII: 7SEV7J4R1U)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: Rugby Laboratories
Labeler Code: 0536
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: 05-10-2021 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.

Rugby Tolnaftate 1% Powder Product Label Images

Rugby Tolnaftate 1% Powder 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

. For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis). Relieves itching, scaling, irritation, and discomfort. Clears up most athlete's foot infection and helps keep it from coming back with daily use

Warnings

For External Use Only

Do Not Use

On children under 2 years of age

When Using This Product

Avoid contact with the eyes

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 (1-800-222-1222) right away

Directions

. Shake well before using. Clean the affected area and dry thoroughly. Apply a thin layer of product over the affected area twice a day (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective on the scalp or nails

For Athlets's Foot

. Use daily for 4 weeks . Pay special attention to the spaces between the toes. Wear well-fitting ventilated shoes . Change shoes and socks at least once daily. To prevent athlete's foot: clean the feet and dry thoroughly, apply once or twice daily

For Ringworm

Use daily for 4 weeks

Other Information

Store between 2°-30ºC (36°-86°F)

Inactive Ingredients

Talc, Corn Starch

* Please review the disclaimer below.