FDA.reportPublic FDA data

83766-001 RDVHDLW Extra Strength NAIL REPAIR PEN

Manufacturer
Shenzhen Joyuflsh Technology Co.,Ltd.
Effective date
2026-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:41

Label at a glance#

ProductRDVHDLW Extra Strength NAIL REPAIR PEN
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate1%

Undecylenic Acid 25%

OTC - PURPOSE SECTION

Anti-fungal and Nail Renewal

INDICATIONS & USAGE SECTION


STRENGTH PENS: Targets foot fungus & discoloration, Fast-drying & easy application, For daily antifungal care.
REPAIR PENS: Hydrates dry, cracked skin, Soothes & restores rough feet,Improves overall foot appearance.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Avoid contact with eyes. If in eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

Irritation occurs or discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs, seek medical attention immediately and contact a Poison Control Center.

DOSAGE & ADMINISTRATION SECTION

1.Wash and dry your nails thoroughly before applying the product. Remove the cap thatcovers the brush.

2.Press the button at the end of the pen to dispense the liquid onto the brush.

3.Apply the liquid three times to the areas requiring treatment, ensuring complete coverageof all affected parts.
4.Use 2-3 times daily for 2-4 weeks, depending on the condition being treated.

INACTIVE INGREDIENT SECTION

ALCOHOL
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
GLYCERIN
LAUROCAPRAM
SOPHORA FLAVESCENS ROOT
TOCOPHEROL
PHENOXYETHANOL
WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83766-001-01RDVHDLW Extra Strength NAIL REPAIR PEN5 in 1 PACKAGELIQUID51
83766-001-01RDVHDLW Extra Strength NAIL REPAIR PEN5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83766-00183766-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
ALCOHOL3K9958V90MIACT
TOCOPHEROLR0ZB2556P8IACT
C12-15 ALKYL LACTATEGC844VRD7EIACT
LAUROCAPRAM1F3X9DRV9XIACT
TOLNAFTATE06KB629TKVACTIB
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT

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
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
ndc (package): 83766-001-01
ndc (product): 83766-001
ndc11 (package): 83766000101
spl id: 4f68796c-11e2-e5f7-e063-6394a90adeb1
spl set id: 4f68796c-11e1-e5f7-e063-6394a90adeb1

Reported adverse events (FAERS/openFDA)#

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