Otc - Active Ingredient
Undecylenic Acid 25%
Tegasolve Toenail Fungus Treatment Liquid
FDA Label NDC 85578-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhengzhou Hangrui Network Technology Co., Ltd. for the product Tegasolve Toenail Fungus Treatment (NDC 85578-003). 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 most nail fungus, athlete's foot, ringworm, andother skin fungus infections
Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails
Warnings
For external use only
Otc - Do Not Use
On children under 2 years of age unless directed by a doctor
Otc - When Using
Avoid contact with eyes
If contact occurs, rinse thoroughly with water
Otc - Stop Use
Irritation occurs
Condition does not improve within 4 weeks
Otc - 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 area thoroughly before application
2, Apply a thin layer of the solution to the affected area twice daily(morningand night)
3, For best results, file affected nails every 2-3 days after soaking in warmwater
4, Continue use for at least 4 weeks, or as directed by a doctor
Inactive Ingredient
Aloe Vera Extract
Tea Tree Oil
Clove Bud Oil
Lavender Oil
Jojoba Oil
Manuka Oil
Peppermint Oil
OREGANO LEAF OIL
PROPOLIS
ALMOND OIL
.ALPHA.-TOCOPHEROL ACETATE (Vitamin E)
Purified Water
Package Label.Principal Display Panel
Label (Label)
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