NDC 59088-443 Mycozyl Al

Tolnaftate

NDC Product Information

Mycozyl Al with NDC 59088-443 is a a human over the counter drug product labeled by Puretek Corporation. The generic name of Mycozyl Al is tolnaftate. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 313423.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Mycozyl Al 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.

  • ARGAN OIL (UNII: 4V59G5UW9X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURETH-4 (UNII: 6HQ855798J)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)

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: Puretek Corporation
Labeler Code: 59088
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: 06-09-2021 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.

Mycozyl Al Product Label Images

Mycozyl Al 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

Antifungal

Uses

■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.■ for the prevention of most Athlete’s foot with daily use.■ eliminates fungus on fingers, toes, and around the nails.■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Warnings

For external use only

Do Not Use On

Children under 2 years of age unless directed by a doctor.

When Using This Product

■ do not get into eyes

Stop Use And Ask A Doctor

■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks

■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor

Keep Out Of Reach Of Children.

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

Directions

■ clean the affected area and dry thoroughly

■ apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails or as directed by a doctor

■ 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 doctor.
Use under the direction of a medical practitioner

Other Information

■ Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].■ avoid excessive heat■ do not use if package is damaged

How Supplied

Mycozyl AL™Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

Inactive Ingredients

Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

Mycozyl Al™

Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340

For questions or information

call toll-free:
877-921-7873

* Please review the disclaimer below.