NDC 43136-104 Avon Hexashield Athletes Foot Cream

Tolnaftate

NDC Product Code 43136-104

NDC Code: 43136-104

Proprietary Name: Avon Hexashield Athletes Foot Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Tolnaftate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 43136 - Tai Guk Pharm. Co., Ltd.
    • 43136-104 - Avon Hexashield Athletes Foot

NDC 43136-104-01

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Avon Hexashield Athletes Foot Cream with NDC 43136-104 is a a human over the counter drug product labeled by Tai Guk Pharm. Co., Ltd.. The generic name of Avon Hexashield Athletes Foot Cream is tolnaftate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Tai Guk Pharm. Co., Ltd.

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.

Avon Hexashield Athletes Foot 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.

  • TOLNAFTATE 10 mg/g

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.

  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • CETETH-20 (UNII: I835H2IHHX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Tai Guk Pharm. Co., Ltd.
Labeler Code: 43136
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: 07-31-2019 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.

Avon Hexashield Athletes Foot 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

Active Ingredient

Tolnaftate 1 %

Purpose

Antifulgal

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

Warnings

For external use only.

When Using This Product

  • Avoid contact with the eyes

Stop Use And Ask A Doctor If :

  • Irritation occursthere is no improvement within 4 weeks

Do Not Use On Children

  • Under 2 years of age except under the advice and supervision of a doctor

Keep Out Of Reach Of Children.

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

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 night)this product is not effective on the scalp or nails

Other Information

  • Store at room temperatureLot No. & Exp. Date: see box or crimp of tube

Inactive Ingredients

Butylated hydroxytolune, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylparaben, sorbitan monostearate, stearyl alcohol, water

* Please review the disclaimer below.

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