Otc - Active Ingredient
TOLNAFTATE(1%)
Ssprotip X Extra Strength Nail Renewal Patches Patch
FDA Label NDC 85966-016
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 Ssprotip X Extra Strength Nail Renewal Patches (NDC 85966-016). 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 effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch.
Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.
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 ยท avoid contact with the eyes or damaged skin.
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. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Clean and dry the affected nail. For best results, gently file down thickened areas before application.
Peel off the protective film. Align the active gel center directly over the nail, ensuring full coverage of the surface and edges.
Press the pear-shaped base to the nail root, wrap the tapered top over the fingertip, and hold firmly for 10s.
Keep the patch on for 24 hours. Replace it once a day (increase frequency for severe cases). Clean the nail thoroughly between replacing.
The patch is water-resistant for showers. Avoid soaking for over 30 minutes. Use a waterproof cover if swimming or bathing.
Use consistently until the damaged nail is fully replaced by healthy, clear growth. Full restoration may take several months.
This product is not effective on the scalp or nails.
Inactive Ingredient
UREA
WATER
LEVOMENOL
TEA TREE OIL
OREGANO LEAF OIL
Package Label.Principal Display Panel
Label3 (Label3)
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