NDC 52099-7005 Footshield Plus

Tolnaftate

NDC Product Code 52099-7005

NDC 52099-7005-1

Package Description: 142 g in 1 TUBE

NDC Product Information

Footshield Plus with NDC 52099-7005 is a a human over the counter drug product labeled by Q.a. Laboratories. The generic name of Footshield Plus is tolnaftate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Q.a. Laboratories

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.

Footshield Plus 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)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • UREA (UNII: 8W8T17847W)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN OIL (UNII: OVV5IIJ58F)
  • EGG WHITE (UNII: 3E0I92Z2GR)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • VITAMIN A (UNII: 81G40H8B0T)
  • VITAMIN D (UNII: 9VU1KI44GP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Q.a. Laboratories
Labeler Code: 52099
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: 02-01-2012 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: 12-31-2021 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’.

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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]

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Footshield Plus Product Label Images

Footshield Plus 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 Purpose

Tolnaftate 1%........................Antifungal

Uses

Proven clinically to cure most:athlete’s foot (tinea pedis) ■ ringworm(tinia corporis). Effectively soothes andrelieves: itching ■ burning ■ cracking ■helps prevent most athlete’s foot fromcoming back with daily use.

Keep Out Of Reach Of Children.

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

Directions

Clean the affected area and drythoroughly ■ apply a thin layer over affected areatwice daily (morning and night). Supervise childrenin the use of this product ■ for athlete’s foot, payspecial attention to spaces between toes. Wearwell-fitting, ventilated shoes, and change shoesand socks at least once daily. ■ use daily for 4weeks. If condition lasts longer, ask a doctor ■ toprevent athlete’s foot, apply to the feet once ortwice daily (morning and night) ■ this product isnot effective on scalp and nails

Warnings

For external use onlyDo not use On children under 2 yearsof age unless directed by a doctor ■When using this product avoid contactwith eyes ■ Stop use andask doctor if: irritation occurs ■ thereis no improvement within 4 weeksFor external use only

Dosage & Administration

Apply a thin layer over affected areatwice daily (morning and night)

Inactive Ingredients

Deionized water,cetearyl alcohol, urea, glycerin, lanolin oil,albumen, ceteareth-20, dimethicone, isopropylmyristate, tea tree oil, mineral oil, aloe vera,phenoxyethanol, allantoin, vitamin E, dexapanthenol,vitamin A, vitamin D, methyl and propyl paraben

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