85966-012 Extra Strength Toenail Renewal Pen

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:59

Label at a glance#

ProductExtra Strength Toenail Renewal Pen
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%
Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

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 SECTION

For external use only. Store in a cool place and avoid sunshine and heat.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

label3label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-012-01Extra Strength Toenail Renewal Pen5 mL in 1 BOTTLE, DROPPERLIQUID51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-01285966-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
ndc (package): 85966-012-01
ndc (product): 85966-012
ndc11 (package): 85966001201
spl id: 4eeb59d2-3892-2e45-e063-6294a90a4fcf
spl set id: 4eeb59d2-3891-2e45-e063-6294a90a4fcf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.