Otc - Purpose
Anti fungal
Nail Antifungal Treatment Liquid
FDA Label NDC 85283-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benm Inc. for the product Nail Antifungal Treatment (NDC 85283-001). 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 - purpose, otc - active ingredient, dosage & administration, otc - when using, inactive ingredient, otc - keep out of reach of children, otc - do not use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Tolnaftate(1%)........................Anti fungal
Salicylic acid(5%) ........................Anti fungal
Dosage & Administration
DIRECTIONS：
1. Apply the product twice a day, in the morning and at night.
2. For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.
3. Use the brush applicator to applythe solution on the affected areas.
4.Visible results will be seen in as little as 2week, continue regular usage toprevent fungus regrowth.
Otc - When Using
When using this product avoid contact with eyes.
Inactive Ingredient
Inactive ingredients：
water,euphorbia hirta whole,glycerin, hydracrylic acid,pseudolarix amabilis bark,resorcinol
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental ingestion,seek medical advice immediately or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use on children under 3 years of age unless directed by a doctor.
Other Safety Information
OTHER INFORMATION
Store at room temperature 15-30°C (59°-86°F)
Warnings
WARNINGS
For external use only.
Indications & Usage
Uses:
For the effective treatment of nail fungus, discoloration, thickening, splitting,crumbling and brittleness.
Otc - Stop Use
Stop and ask a doctor if-irritation occurs-there is no improvement
within 4 weeks.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of accidental ingestion,seek medical advice immediately or
contact a Poison Control Center right away.
* Please review the disclaimer below.
