Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 59088-443 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mycozyl al |
||||||
| Type | Brand | ||||||
| Active Ingredients |
|
||||||
| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 313423 | ||||||
| Labeler Name | PURETEK CORPORATION | ||||||
| Packages |
|
||||||
| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Mycozyl AL
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE: (See PRECAUTIONS).
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY: Tolnaftate has antifungal properties.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics: Tolnaftate is only given topically, and there are no documented reports on its pharmacokinetics and systemic metabolism.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS: Tolnaftate topically applied is not likely to affect drugs taken or injected, but many drugs can interact with each other.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION: 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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND 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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND 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.
Spl product data elements
Usually a list of ingredients in a drug product.Mycozyl AL Tolnaftate .ALPHA.-TOCOPHEROL ACETATE, DL- TOLNAFTATE TOLNAFTATE POLYETHYLENE GLYCOL 400 TEA TREE OIL GLYCERIN DIMETHYL SULFOXIDE BENZYL ALCOHOL LAURETH-4 APPLE CIDER VINEGAR EUCALYPTUS OIL ARGAN OIL LAVENDER OIL
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Tolnaftate.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Mycozyl AL™ Label
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers: Before using this medication while breastfeeding, it is recommended to consult with a healthcare professional.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 2 years of age.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy: Teratogenic effects - There is currently no published human data available on the teratogenic and fetotoxic effects of tolnaftate.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General: Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes, lips and mucous membranes.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API