NDC 68016-152 Tolnaftate Cream 1%

Tolnaftate

NDC Product Information

Tolnaftate Cream 1% with NDC 68016-152 is a a human over the counter drug product labeled by Pharmacy Value Alliance, Llc.. The generic name of Tolnaftate Cream 1% is tolnaftate. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 103951.

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.

Tolnaftate Cream 1% 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.


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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Pharmacy Value Alliance, Llc.
Labeler Code: 68016
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: 08-23-2016 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.

Tolnaftate Cream 1% Product Label Images

Tolnaftate Cream 1% 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

Anti-Fungal

Uses

  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)Helps prevent most athlete's foot with daily useFor effective relief of itching, burning, and cracking

Keep Out Of The Reach Of Children

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

Warnings

For External Use OnlyWhen using this product avoid contact with the eyes
Do not use on children under 2 years of age except under the advice and supervision of a doctor

Directions

  • Wash affected area and dry thoroughlyApply a thin layer over affected area twice daily (morning and night)Supervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once dailyUse daily for 4 weeks; if condition persists longer, ask a doctorTo prevent athlete's foot, apply once or twice daily (morning and/or night)This product is not effective on the scalp or nails

Stop Use And Ask A Doctor If

  • Irritation occursthere is no improvement within 4 weeks

Other Information

  • Store between 20° to 25°C (68° to 77°F)Lot No & Expiration Date: See box or crimp of tube

Inactive Ingredients:

Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

Soothes Itching, Burning And Cracking

Distributed By:Pharmacy Value Alliance, LLC.407 East Lancaster Avenue, Wayne, PA. 19087 USAwww.emersongroup.com

* Please review the disclaimer below.