Lamisil At For Jock Itch
Terbinafine Hydrochloride
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8114Lamisil At For Jock Itch also known as Terbinafine Hydrochloride is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Lamisil At For Jock Itch is 0067-8114. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Lamisil At For Jock Itch drug includes Terbinafine Hydrochloride - 1 g/100g . The currest status of Lamisil At For Jock Itch drug is Active.
Drug Information:
| Drug NDC: | 0067-8114 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Lamisil At For Jock Itch |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Lamisil At |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | for Jock Itch |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Terbinafine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TERBINAFINE HYDROCHLORIDE - 1 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 02 Jul, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA077511 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 992528
992530
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 012C11ZU6G
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Allylamine Antifungal [EPC]
Allylamine [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0067-8114-12 | 1 TUBE in 1 CARTON (0067-8114-12) / 12 g in 1 TUBE | 02 Jul, 2007 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antifungal
Product Elements:
Lamisil at for jock itch terbinafine hydrochloride terbinafine hydrochloride terbinafine benzyl alcohol cetyl alcohol cetyl palmitate isopropyl myristate polysorbate 60 water sodium hydroxide sorbitan monostearate stearyl alcohol
Indications and Usage:
Uses ⢠cures most jock itch (tinea cruris) ⢠relieves itching, burning, cracking and scaling which accompany this condition
Warnings:
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 the eyes. if eye contact occurs, rinse thoroughly with water. 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.
Do Not Use:
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 the eyes. if eye contact occurs, rinse thoroughly with water. 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.
When Using:
When using this product do not get into the eyes. if eye contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions ⢠adults and children 12 years and older: ⢠use the tip of the cap to break the seal and open the tube ⢠wash the affected skin with soap and water and dry completely before applying ⢠apply 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
Stop Use:
Stop use and ask a doctor if too much irritation occurs or gets worse
Package Label Principal Display Panel:
Principal display panel - 12 g tube carton ndc 0067-8114-12 terbinafine hydrochloride cream 1% - antifungal lamisil at ® cream for jock itch relieves itching and burning net wt. 12 g (.42 oz) principal display panel - 12 g tube carton
Further Questions:
Questions or comments? call 1-800-330-9876