NDC 44577-001 Clarus Antifungal

Tolnaftate

NDC Product Code 44577-001

NDC 44577-001-01

Package Description: 45 g in 1 TUBE

NDC Product Information

Clarus Antifungal with NDC 44577-001 is a a human over the counter drug product labeled by Clinical Therapeutic Solutions. The generic name of Clarus Antifungal is tolnaftate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinical Therapeutic Solutions

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.

Clarus Antifungal 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.

  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • LAURETH-7 (UNII: Z95S6G8201)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • UREA (UNII: 8W8T17847W)

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: Clinical Therapeutic Solutions
Labeler Code: 44577
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: 06-07-2012 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.

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]

* Please review the disclaimer below.

Clarus Antifungal Product Label Images

Clarus Antifungal 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:

For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).  Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.

Warnings

For external use only.  Avoid contact with eyes.

Do Not Use

On children under 2 years of age unless directed by a physician.

Stop Use And Ask Physician If:

  • When using for athlete's foot or ringworm:  if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician.

If Pregnant Or Breast-Feeding,

Ask a healthcare professional before use.

Keep Out Of Reach Of Children

In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions:

  • For treatment of athlete's foot and ringworm:Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician.Supervise children in the use of this product.For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.For athlete's foot and ringworm: Use daily for 4 weeks. If condition persists longer, consult a physician. This product is not effective on scalp or nail infections.To prevent athlete's foot:Clean the feet and dry thoroughly.Apply a thin layer of the product to the feet once or twice daily (morning and/or night).Supervise children in the use of this product.Pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once daily.

Other Information:

Store between 20


0-25


0C (68


0-77


0F)

Inactive Ingredients:

Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.

* Please review the disclaimer below.