NDC 0067-6296 Lamisil AT

Terbinafine Hydrochloride

NDC Product Code 0067-6296

NDC 0067-6296-01

Package Description: 125 mL in 1 CAN

NDC Product Information

Lamisil AT with NDC 0067-6296 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Lamisil AT is terbinafine hydrochloride. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.

Lamisil AT 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.

  • TERBINAFINE HYDROCHLORIDE .84 g/125mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
FDA Application Number: NDA021124 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: NDA - A product marketed under an approved New Drug Application. 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: 03-07-2018 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’.

* Please review the disclaimer below.

Lamisil AT 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

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • •cures most athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown. •cures most jock itch (tinea cruris) and ringworm (tinea corporis) •relieves itching, burning, cracking, and scaling which accompany these conditions

Warnings

For external use only

Do Not Use

  • •on nails or scalp •in or near the mouth or the eyes •for vaginal yeast infections

When Using This Product

  • •do not get into eyes. If contact occurs, rinse eyes thoroughly with water. •do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120ºF (49ºC).

Stop Use And Ask A Doctor If

Too much irritation occurs or gets worse

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • •adults and children 12 years and over: •wash the affected area with soap and water and dry completely before applying •to open remove clear cap •hold can 4" to 6" from skin.  Press and hold to spray a thin layer over affected area •spray affected area once a day (morning or night) for 1 week or as directed by a doctor •release to stop spray •wipe excess from spray opening after each use •return cap to can •for athlete’s foot between the toes spray twice a day (morning and night) for 1 week or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. •for jock itch and ringworm spray affected area once a day (morning or night) for 1 week or as directed by a doctor •wash hands after each use •children under 12 years: ask a doctor

Other Information

Store at 20 to 25°C (68 to 77°F)

Inactive Ingredients

Ethanol, polyoxyl 20 cetostearyl ether, propylene glycol, purified water

Questions?

Call 1-800-330-9876

* Please review the disclaimer below.