Active Ingredient
Tolnaftate 1%
Antifungal
FDA Label NDC 72109-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dong Yuan Technology Co., Ltd. for the product Antifungal (NDC 72109-001). 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, 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
Uses
■ proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) ■ helps prevent most athlete's foot with daily use ■ for effective relief of itching, burning, and cracking
Warnings
For external use only
Flammable: Do not use while smoking or near heat or flame
Do Not Use
on children under 2 years of age unless directed by a doctor
When Using This Product
■ avoid contact with eyes ■ use only as directed. Intentional misuse by deliberetely concentrating and inhaling contents can be harmful or fatal ■ contents under pressure. Do not puncture or incinerate.
Do not stire at a temperature above 120°F (49°C)
Stop Use And Ask A Doctor If
■ irritation occurs ■ 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
Directions
■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ 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 a day ■ use daily for 4 weeks, if conditions persist longer, ask a doctor ■ to prevent athlete's foot, apply once or twice daily (morning and/or night) ■ this product is not effective on the scalp or nails ■ in case of clogging, clean nozzle with pin
Other Information
■ store between 68° to 77°F (20° to 25°C)
Inactive Ingredients
alcohol denat., butane, fragrance, propane, triethanolamine, zea mays (corn) starch
Package Label
Package Label (Antfnglsprypwdr)
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