NDC 0113-0695 Good Sense Jock Itch

Tolnaftate

NDC Product Code 0113-0695

NDC 0113-0695-90

Package Description: 130 g in 1 CAN

NDC Product Information

Good Sense Jock Itch with NDC 0113-0695 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Jock Itch is tolnaftate. The product's dosage form is spray and is administered via topical form.

Labeler Name: L. Perrigo Company

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Good Sense Jock Itch 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.

  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • ISOBUTANE (UNII: BXR49TP611)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • TALC (UNII: 7SEV7J4R1U)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

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.
  • 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: L. Perrigo Company
Labeler Code: 0113
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: 06-15-2005 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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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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Good Sense Jock Itch Product Label Images

Good Sense Jock Itch 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

  • •cures most jock itch •for effective relief of itching, chafing and burning

Warnings

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

Do Not Use

On children under 2 years of age unless directed by a doctor

When Using This Product

  • •avoid contact with the eyes •use 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 (49°C).

Stop Use And Ask A Doctor If

  • •irritation occurs •there is no improvement within 2 weeks

Keep Out Of Reach Of Children.

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

Directions

  • •wash affected area and dry thoroughly •shake can well and spray a thin layer over affected area twice daily (morning and night) •supervise children in the use of this product •use daily for 2 weeks; if condition persists longer, ask a doctor •this product is not effective on the scalp or nails •in case of clogging, clean nozzle with a pin

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients

Alcohol denat., aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

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