OTC - ACTIVE INGREDIENT SECTION
Undecylenic Acid 25%
Tolnaftate 1%
Undecylenic Acid 25%
Tolnaftate 1%
Antifungal
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.
For external use only. Store in a cool place and avoid sunshine and heat.
Do not use on children under 2 years of age unless directed by a doctor.
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
Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
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
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85966-012-01 | Extra Strength Toenail Renewal Pen | 5 mL in 1 BOTTLE, DROPPER | LIQUID | 5 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 85966-012 | 85966-012-01 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Extra Strength Toenail Renewal Pen | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeb59d2-3891-2e45-e063-6294a90a4fcf | 2026-04-07 | Warnings | 85966-012-01 85966-012 85966001201 4eeb59d2-3892-2e45-e063-6294a90a4fcf 4eeb59d2-3891-2e45-e063-6294a90a4fcf |
Adverse event summaries are temporarily unavailable. Other product information remains available.