FDA.reportPublic FDA data

85038-002 TOENAIL FUNGUS TREATMENT Liquid

Manufacturer
Lianjiang Shanlilai E-commerce Co., Ltd.
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:27

Label at a glance#

ProductTOENAIL FUNGUS TREATMENT Liquid
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure13 sections

Storage and handling

Store betwseen 15° to 30 ° C (59° to 86 ° F)Avoid freezing and excessive heat above 40° C(104° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TOENAIL FUNGUS TREATMENT Liquid

OTC - ACTIVE INGREDIENT SECTION

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

For the effective treatment of nail fungus,discoloration,thickening,splitting,crum
bling and brittleness.

WARNINGS SECTION

For externat use only.

OTC - DO NOT USE SECTION

chlldren under 2 years of age.
pregnant or if there is any allergic reaction to this produce.

OTC - WHEN USING SECTION

When using this product Avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if lrritation occurs or discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

oif product gets Into eyes,flush with water for 15 minutes.

if swallowred,get medical help or contact a Poison Control Center rightaway.

DOSAGE & ADMINISTRATION SECTION

For initlal use, soak the affected part and soften the nalt in warm water.Gently remove dirt from the naiis, being careful not to damage the nail bed.
Apply full layers of nait solution with brush onto affected areas on ,around.and under nails,.A light tingle or burn is normal for the frst 10 minutes untilthe product is absorbed into the skin.
Apply the product twice a day, in the morning and at night.
Visible resuits will be seen in as little as 7 days, carry out regular use toprevent fungal growth.

STORAGE AND HANDLING SECTION


Store betwseen 15° to 30 ° C (59° to 86 ° F)Avoid freezing and excessive heat above 40° C(104° F)

INACTIVE INGREDIENT SECTION

ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN2
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD2
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-002-01TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID302
85038-002-01TOENAIL FUNGUS TREATMENT Liquid1 in 1 PACKAGELIQUID12
85038-002-02TOENAIL FUNGUS TREATMENT Liquid2 in 1 PACKAGELIQUID22
85038-002-02TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID302

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85038-00285038-002-01, 85038-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
TOCOPHEROLR0ZB2556P8IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
TEA TREE OILVIF565UC2GIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SAFFLOWER OIL65UEH262ISIACT
TOLNAFTATE06KB629TKVACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT

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
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
ndc (package): 85038-002-02
ndc (package): 85038-002-01
ndc (product): 85038-002
ndc11 (package): 85038000201
ndc11 (package): 85038000202
spl id: 4e77eb15-0dea-0778-e063-6394a90ad359
spl set id: 28fc7049-e367-42bf-e063-6394a90a6f06