Otc - Active Ingredient
TOLNAFTATE 1%
Fungal Nail Patches Patch
FDA Label NDC 85966-006
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 Saweilan Import & Export Trading Co., Ltd for the product Fungal Nail Patches (NDC 85966-006). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Antifungal
Indications & Usage
For the effective treatment of nall fungus, discoloration, thickening, splitting, crumbling and brittleness.
Restore and improve the appearance of nails that have been affected by fungus.
Warnings
For external use only. Store in a cool place and avoid sunshine and heat.
Otc - Do Not Use
Do not use · on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product · avoid contact with the eyes or damaged skin.It's normal to feel a slight, temporary sensation of irritation, tingling, or burning. lf symptoms persist or worsen,discontinue use.
Otc - Stop Use
Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
1.Clean and dry the affected nail and surrounding area.
2.Remove the patch from its protective film.
3.Place it directly onto the infected nail, ensuring full coverage.
4. Gently press down on the edges of the patch to make sure it is firmly adhered to the nail and skin, with no airbubbles.
5. Keep the patch on for 24 hours. Replace it once a day, preferably after showering.
Inactive Ingredient
WATER
UREA
LACTIC ACID
GLYCERIN
TERPINEN-4-OL
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Label (Label)
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