Antifungal Foot Aerosol, Spray
FDA Label NDC 52000-418
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Antifungal Foot (NDC 52000-418). 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 drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Tolnaftate 1%
Purpose
Antifungal
Use
• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• if used daily, can prevent recurrence of athlete's foot
• relieves symptoms of athlete's foot, including, burning and cracking
Warnings
For external use only.
Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F (49°C).
When using this product • avoid contact eyes & face • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
Stop use and ask a doctor if • irritation occurs • there is no improvement after 4 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.
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 space between the toes; wear well-fitted, ventilated shoes and change shoes and socks at least once a day.
• use daily for 4 weeks; if condition persists longer, consult a doctor
• to prevent athlete's foot, apply once or twice daily (morning and night)
• in case of clogging, clean nozzle with a pin
Other Information
store between 68° to 77°F (20° to 25°C)
Questions/Comments?
1-855-345-5575
Inactive Ingredients
butane, propane, alcohol, butylated hydroxytoluene, Zea Mays Starch.
Packaging
Antfspray-3 (52000418 3)
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