NDC 61047-120 Lamisil At Cream

Terbinafine Hydrochloride

NDC Product Code 61047-120

NDC 61047-120-01

Package Description: 1 TUBE in 1 CARTON > 12 g in 1 TUBE

NDC 61047-120-02

Package Description: 1 TUBE in 1 CARTON > 12 g in 1 TUBE

NDC 61047-120-03

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC Product Information

Lamisil At Cream with NDC 61047-120 is a a human over the counter drug product labeled by Kik Holdco Company Inc.. The generic name of Lamisil At Cream is terbinafine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Kik Holdco Company Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Cream 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 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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

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: Kik Holdco Company Inc.
Labeler Code: 61047
FDA Application Number: NDA020980 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: 02-20-2020 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: 12-31-2021 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 Cream 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

Otc - Active Ingredient

Terbinafine hydrochloride 1%

Otc - Purpose

Antifungal

Uses

- cure most jock itch (tinea cruris) and ringworm (tinea corporis)- relieves itching, burning, cracking andf scaling which accompany this condition

Warnings

For external use only

Otc - Do Not Use

Do not use - on nails or scalp- in or near the mouth or eyes- for vaginal yeast infections

Otc - When Using

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water

Otc - Stop Use

Stop use and ask a doctor if too much irritation occurs or gets worse

Otc - Keep Out Of Reach Of Children

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:- 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- for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.- between toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor- for jock itch and ringworm: 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

  • - adults and children 12 years and over:use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctoron the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctorfor jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctorwash hands after each use- children under 12 years: ask a doctor

Other Information

- do no use if seal on tube is broken or is not visible- store at controlled room temperature 20-25C (68-77F)

Inactive Ingredients

Benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearly alcohol

12 G Tube With Carton - For Jock Itch

Lamisil ATCream Terbinafine Hydrochloride Cream 1% - AntifungalFor JOCK ITCH- cures most jock itch- for effective relief of itching and burningNET WT12 g (0.42 oz)

12 G Tube With Carton - For Athlete's Foot

Lamisil AT CreamTerbinafine Hydrochloride Cream 1% - AntifungalFor Athlete's FootNet Wt 12 g (0.42 oz)

30 G Tube With Carton - For Athlete's Foot

Lamisil AT CreamTerbinafine Hydrochloride Cream 1% - AntifungalFor Athlete's FootNET WT30 g (1 oz)

* Please review the disclaimer below.