Otc - Active Ingredient
Tolnaftate 1%
Flyleaf Fungal Nail Treatment Liquid
FDA Label NDC 87204-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Huixue Biotechnology Co., Ltd. for the product Flyleaf Fungal Nail Treatment (NDC 87204-164). 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 otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - when using, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Aloe Vera Extract, Helianthus Annuus (Sunflower) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Hakka Yu, Tocopherol, Origanum Vulgare Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Eucalyptol, Tocopheryl Acetate, Squalene, Propolis Extract, Citrus Bergamia (Bergamot) Fruit Oil.
Otc - Purpose
Antifungal
Indications & Usage
For the treatment of nail fungus and associated symptoms, including discoloration, thickening, splitting, crumbling, and brittleness. . Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Hetps prevent most athtete's foot (dermatophytosis) with daily use.
Warnings
Warnings For external use only. De not use on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with the eyes. tion occurs or if there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Store at room temperature. Avoid direct sunlight.
Otc - When Using
1. 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. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results, file nails every 2-3 days. 2. 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. To prevent athlete's foot, apply once or twice daily (morning and/or night). For toe fungus, apply to skin around the nail and cuticle. Visible improvement may be seen in as little as 7 days. Continue regular use to help prevent fungus regrowth.
Otc - Do Not Use
For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.
Otc - Stop Use
irritation occurs or if there is no improvement within 4 weeks.
Dosage & Administration
Twice each day,(1ml)each time.7 days supply
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