Otc - Active Ingredient
Undecylenic Acid 25%
Tolnaftate 1%
Extra Strength Toenail Renewal Pen Liquid
FDA Label NDC 85966-012
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 Toenail Renewal Pen (NDC 85966-012). 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
Helps improve the appearance of nails and supports the renewal of discolored or rough nail surfaces through
mechanical and chemical exfoliating action.
Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Relieves itching, scaling, cracking, burning, and discomfort associated with these conditions.
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.
Use twice daily until a healthy new nail has fully grown Trim and file nails to support maximum absorption.
The elastic bandage should not be wrapped too tightly. Change daily.
The nail file is for single-person use. Do not share or reuse
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 the affected nail and dry thoroughly. File the nail surface to remove thickness
Pro Tip: To prevent re-infection, always disinfect the file with 70% rubbing alcohol after each use.
Twist the base of the pen clockwise until the liquid flows to the nib.
Apply a thin layer of the product over affected area twice daily (morning and night. Wait 2-3 minutes for the treatment to be fully absorbed.
Allow to dry, then apply the affected toe with the waterproof protective film. For best results, use overnight or
before wearing shoes to keep the medication in place.
NOTE:
For athlete's 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 a full 4-week course. If symptoms persist, consult a doctor. Not
intended for use on the scalp or nails.
This product is not effective on the scalp or nails.
Inactive Ingredient
Urea
Ethoxydiglycol
Lactic Acid
Dimethyl Sulfone
Biotin
Melaleuca Ericifolia Leaf Oil
Leptospermum Scoparium Branch/Leaf Oil
Eucalyptus Globulus Leaf Oil
Origanum Vulgare Leaf Oil
Eugenia Caryophyllus (Clove) Bud Oil
Squalane
Simmondsia Chinensis Seed Oil
Salicylic Acid
Tocopheryl Acetate
Ethylhexylglycerin
Aqua
Package Label.Principal Display Panel
Label3 (Label3)
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