Otc - Active Ingredient
UNDECYLENIC ACID 25%
TOLNAFTATE 1%
Nail Fungus Treatment Pen Liquid
FDA Label NDC 85966-005
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 Nail Fungus Treatment Pen (NDC 85966-005). 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.
Provides effective relief from itching, scaling, burning, redness, sorenessand irritation while curing most athlete's foot (tinea pedis) and jock itch(tinea cruris).
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 · 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
Clean and dry the affected nail and surrounding area.
Twist the base of the pen clockwise until the brush tip is saturated.
Apply a thin layer to the entire nail. Let it dry for 2-3 minutes.
Apply twice daily (morning and night) until a healthy nail has fully grown out.
For athletes foot: Pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and jock itch, use daily for 4 weeks..This product is not effective on the scalp or nails. lf condition persistslonger, consult a doctor.
Inactive Ingredient
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
OREGANO OIL
CEYLON CINNAMON BARK OIL
LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT
CAPRYLIC/CAPRIC DIGLYCEROL SUCCINATE
ISOPROPYL MYRISTATE
TOCOPHEROL
BISABOLOL
PANTHENOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
Package Label.Principal Display Panel
Label (Label)
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