Otc - Active Ingredient
UNDECYLENIC ACID 25%
TOLNAFTATE 1%
Extra Strength Nail Fungus Treatment Liquid
FDA Label NDC 85966-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Saweilan Import & Export Trading Co., Ltd for the product Extra Strength Nail Fungus Treatment (NDC 85966-001). 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 - 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 nail fungus, discoloration, thickening, splitting, crumbling and brittleness
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
For effective relief of itching, scaling, burning, redness, soreness, and irritation.
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. lf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
1. Regularly trim the affected nails and gently file the surface (once a month or as needed).
2. Shake well before use. Wash the affected nails and surrounding skin with soap and water and dry thoroughly.
3. Using a sterile disposable cotton swab or dropper, apply a thin layer of the product over affectedarea twice daily (morning and night). Use a new swab each time to avoid cross-contamination.
4. Allow the product to air-dry completely before putting on socks or shoes to ensure full absorption.
5. For best results, apply daily until a healthy new nail has fully grown out. This product is noteffective on the scalp or nails.
Inactive Ingredient
UREA
ETHOXYDIGLYCOL
PROPYLENE GLYCOL
ALCOHOL DENAT.
TEA TREE OIL
OREGANO OIL
LAVENDER OIL
MENTHOL
ALOE BARBADENSIS LEAF EXTRACT
SALICYLIC ACID
BIOTIN/VITAMIN H
TOCOPHEROL ACETATE / VITAMIN E
AQUA
GLYCERIN
Package Label.Principal Display Panel
Label (Label)
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