FDA.reportPublic FDA data

85966-013 Extra Strength Toenail Renewal Solution

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-04-08
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 Solution
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 nal surfaces through mechanical and chemical exfoliating action.

Proven clinically effective in the treatment of most athletes foot (tinea pedis). jockich (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.

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 nal and dy thoroughly Fie the nallsurface to remove thickness After each use, wrap the nail file in a tissue and discard it (for single use only)
Use a dropper to apply and a cotton swab to spread evenly. If using a brush, replace it regularly
Apply a thin layer of the product over affected area twice daly morning and night Wait 2-3 minutes for the treamentto be fully absorbed.
Allow to dny.then wrap the afected toe with the antfungal bandage.For best resuts use overnight or before wearing shoestokeep the medication in place The bandage is self-adhesive.
TIPS:
For athlete's foot Pay special attention to spaces between the toes wear well-ftting ventilated shoes and change shoes and socks at least once daily
For athlete's foot and jock ich. use daily for a full4-week course Ifsymptoms persist. consut 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
Melaleuca Ericifolia Leaf Oil
Eucalyptus Globulus Leaf Oil
Leptospermum Scoparium Branch/Leaf Oil
Origanum Vulgare Leaf Oil
Eugenia Caryophyllus (Clove) Bud Oil
Salicylic Acid
Simmondsia Chinensis Seed Oil
Tocopheryl Acetate
Biotin
Glycerin
Aqua

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label4label4

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
85966-013-01Extra Strength Toenail Renewal Solution30 mL in 1 BOTTLESOLUTION301
85966-013-02Extra Strength Toenail Renewal Solution5 mL in 1 BOTTLE, DROPPERSOLUTION51

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-01385966-013-01, 85966-013-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OILM6QU9ZUH2XIACT
UREA8W8T17847WIACT
BIOTIN6SO6U10H04IACT
GLYCERINPDC6A3C0OXIACT
AQUA059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
ETHOXYDIGLYCOLA1A1I8X02BIACT
LACTIC ACID33X04XA5ATIACT
TOLNAFTATE06KB629TKVACTIB
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ORIGANUM VULGARE LEAF OIL7D0CGR40U1IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL578389D6D0IACT

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 SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
ndc (package): 85966-013-01
ndc (package): 85966-013-02
ndc (product): 85966-013
ndc11 (package): 85966001302
ndc11 (package): 85966001301
spl id: 4eed68e6-6815-0181-e063-6394a90a888e
spl set id: 4eed68e6-6814-0181-e063-6394a90a888e

Reported adverse events (FAERS/openFDA)#

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