Otc - Active Ingredient
Tolnaftate 1%
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Fungal Nail Patches (NDC 84763-017). 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.
Tolnaftate 1%
Antifungal
Helps improve the appearance of discolored, damaged nails caused by fungal exposure.
For external use only.
On children under 2 years of age unless directed by a doctor If you are allergic to any ingredient in this product
Avoid contact with eyes
Do not use on broken or severely damaged skin
Discontinue use if irritation or redness develops
Irritation worsens
There is no improvement within 4 weeks
Symptoms recur after improvement
If swallowed, get medical help or contact a Poison Control Center right away.
1. Wash and dry the affected nail thoroughly.
2. Apply one patch to the affected nail before bedtime.
3. Leave the patch on for at least 10 hours or overnight.
4. Remove the patch in the morning and discard after use.
5. Repeat nightly or as directed.
Acrylic Adhesive
Ethylene/Vinyl Acetate Copolymer
Hydrogenated Rosin Glycerol Ester
Mineral Oil
Oleic Acid
Polyisobutylene
Polyester Film
Propylene Glycol
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