Active Ingredient
Miconazole Nitrate 2%
Tolnaftate 1%
Mycozyl Ap Powder
FDA Label NDC 59088-442
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Mycozyl Ap (NDC 59088-442). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Antifungal
Uses
- for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
- relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
- 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.
For external use only
Do Not Use On
- children under 2 years of age unless directed by a doctor
children under 2 years of age unless directed by a doctor.
When Using This Product
- do not get into eyes
- do not get into eyes
Stop Use And Ask A Doctor If
- for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
- for jock itch - irritation occurs or there is no improvement within 2 weeks
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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) 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
- for jock itch, use daily for 2 weeks
- if condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
- 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
- protect from freezing
- avoid excessive heat
- do not use if package is damaged
- Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].
- avoid excessive heat
- do not use if package is damaged
Inactive Ingredients
Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.
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.
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
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)
Miconatate™
Packaged in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
877-921-7873
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