FDA.reportPublic FDA data

Extra Strength Nail Fungus Treatment

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:12:21

Label at a glance#

ProductExtra Strength Nail Fungus Treatment
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 25%
TOLNAFTATE 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION


For the effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and brittleness
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
For effective relief of itching, scaling, burning, redness, soreness, and irritation.
Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.

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. lf swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

1. Regularly trim the affected nails and gently file the surface (once a month or as needed).

2. Shake well before use. Wash the affected nails and surrounding skin with soap and water and dry thoroughly.

3. Using a sterile disposable cotton swab or dropper, apply a thin layer of the product over affectedarea twice daily (morning and night). Use a new swab each time to avoid cross-contamination.

4. Allow the product to air-dry completely before putting on socks or shoes to ensure full absorption.

5. For best results, apply daily until a healthy new nail has fully grown out. This product is noteffective on the scalp or nails.

INACTIVE INGREDIENT SECTION

UREA
ETHOXYDIGLYCOL
PROPYLENE GLYCOL
ALCOHOL DENAT.
TEA TREE OIL
OREGANO OIL
LAVENDER OIL
MENTHOL
ALOE BARBADENSIS LEAF EXTRACT
SALICYLIC ACID
BIOTIN/VITAMIN H
TOCOPHEROL ACETATE / VITAMIN E
AQUA
GLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN3
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD3
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-001-01Extra Strength Nail Fungus Treatment30 mL in 1 BOTTLELIQUID303
85966-001-02Extra Strength Nail Fungus Treatment30 mL in 1 BOTTLELIQUID303
85966-001-02Extra Strength Nail Fungus Treatment2 in 1 BOXLIQUID23

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
85966-00185966-001-01, 85966-001-02

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
AQUA059QF0KO0RIACT
BIOTIN6SO6U10H04IACT
LAVENDER OILZBP1YXW0H8IACT
UREA8W8T17847WIACT
MENTHOLL7T10EIP3AIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
OREGANO LEAF OIL7D0CGR40U1IACT
SALICYLIC ACIDO414PZ4LPZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TEA TREE OILVIF565UC2GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
TOLNAFTATE06KB629TKVACTIB
UNDECYLENIC ACIDK3D86KJ24NACTIB
ALOE BARBADENSIS LEAF POWDERZY81Z83H0XIACT

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 Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
ndc (package): 85966-001-01
ndc (package): 85966-001-02
ndc (product): 85966-001
ndc11 (package): 85966000101
ndc11 (package): 85966000102
spl id: 3dced015-71fd-f6ab-e063-6294a90a0dc3
spl set id: 3abc0892-e52b-a40f-e063-6294a90a0e35

Reported adverse events (FAERS/openFDA)#

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