NDC 63868-529 Quality Choice Antifungal

Tolnaftate

NDC Product Code 63868-529

NDC Code: 63868-529

Proprietary Name: Quality Choice Antifungal 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

  • 63868 - Chain Drug Marketing Association Inc.
    • 63868-529 - Quality Choice Antifungal

NDC 63868-529-28

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

NDC Product Information

Quality Choice Antifungal with NDC 63868-529 is a a human over the counter drug product labeled by Chain Drug Marketing Association Inc.. The generic name of Quality Choice Antifungal is tolnaftate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Chain Drug Marketing Association Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Quality Choice 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 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.

  • STEARETH-20 (UNII: L0Q8IK9E08)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • SULFITE ION (UNII: 15744271E9)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Chain Drug Marketing Association Inc.
Labeler Code: 63868
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: 07-05-2019 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.

Quality Choice Antifungal Product Label Images

Quality Choice 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

Otc - Active Ingredient

Active ingredient PurposeTolnaftate 1%............................................................Antifungal

Otc - Purpose

  • Usesproven 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

WarningsFor external use only

Otc - Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Otc - When Using

When using this product, avoid contact with the eyes.

Otc - Stop Use

  • Stop use and ask a doctor if​irritation occurs
  • There is no improvement within 4 weeks

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Indications & Usage

  • Directionswash affected area and dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.to prevent athlete's foot, apply once or twice daily (morning and/or night)this product is not effective on the scalp or nails

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68°-77°F)

Inactive Ingredient

Inactive ingredientscetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

Dosage & Administration

Distributed by C.D.M.A., Inc.43157 W 9 Mile RdNovi, MI 48375www.qualitychoice.comMade in China

* Please review the disclaimer below.

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