Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Mycozyl AL™ is supplied in: 10 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-01). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. Do not use if package is damaged. Keep out of reach of children. Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873; Mycozyl AL™ Label
- HOW SUPPLIED: Mycozyl AL™ is supplied in: 10 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-01). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. Do not use if package is damaged. Keep out of reach of children. Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873
- Mycozyl AL™ Label
Overview
Each gram of Mycozyl AL™ contains 10 mg of tolnaftate in a vehicle consisting of: 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. Chemically, tolnaftate molecular formula is C19H17NOS and molecular weight 314.5 and is represented by the following structure formula: Structure
Indications & Usage
: Mycozyl AL™ is effective in the treatment of most skin infections such as athlete's foot (tinea pedis) and ringworm (tinea corporis). Mycozyl AL™ has been designed to reach skin areas around and under the nails while it relives burning, cracking, scaling and discomfort which accompany these conditions. Mycozyl AL™ is an antifungal that works by preventing and eliminating the growth of fungus on fingers, toes and around the nails. It eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush. Mycozyl AL™ cures and prevents fungal infections from coming back with daily use.
Dosage & Administration
: • Clean the affected area with soap and warm water and dry thoroughly • Apply a thin layer of 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 • The brush applicator allows for easy application on skin around the nail and cuticle areas. • 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. • Supervise children in the use of this product. Use under the direction of a licensed medical practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1
Warnings & Precautions
WARNINGS: For External Use Only. Not For Ophthalmic Use
Contraindications
: Tolnaftate topically applied is not likely to affect drugs taken or injected, but many drugs can interact with each other.
Adverse Reactions
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.
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