FDA.reportPublic FDA data

VITAL SYNERGY - TOENAIL FUNGUS SOLUTION / NAIL REPAIR PEN (82743-101)

Manufacturer
VITAL SYNERGY LLC
Effective date
2022-05-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:17:27

Label at a glance#

ProductTOENAIL FUNGUS / NAIL REPAIR PEN
Active ingredientTEA TREE OIL
Label structure8 sections

Indications and uses

STRONG NAILS FAST YELLOW BROKEN BRITTLE TOENAILS & FINGERNAILS

Dosage and administration

TEST ON A SMALL PART OF A NAIL FIRST. APPLY TOPICALLY TWICE PER DAY ON THE AFFECTED AREA.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TEA TREE OIL 10X HPUS

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

USES

INDICATIONS & USAGE SECTION

STRONG NAILS FAST

YELLOW BROKEN BRITTLE TOENAILS & FINGERNAILS

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF ADVERSE SKIN REACTION OCCURS. CONSULT YOUR HEALTH CARE PHYSICIAN IF PREGNANT, NURSING, OR FOR A CHILD UNDER THE AGE OF TWO.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

TEST ON A SMALL PART OF A NAIL FIRST. APPLY TOPICALLY TWICE PER DAY ON THE AFFECTED AREA.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALOE VERA EXTRACT, EUCALYPTUS OIL, LAVENDER OIL, SWEET ALMOND OIL, VITAMIN C, AND VITAMIN E

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Vital Synergy_Nail Repair Pen_3mL01b UC_Vital Synergy_Nail Repair Pen_3mL

01b UC_Vital Synergy_Toenail Fungus Solution_30mL01b UC_Vital Synergy_Toenail Fungus Solution_30mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82743-101-302024-01-30C16284748780-11030e365-4e5f-111a-e063-dadaa90a10e2VITAL SYNERGY - TOENAIL FUNGUS SOLUTION / NAIL REPAIR PEN (82743-101)
82743-101-632024-01-30C16284748780-11030e365-4e5f-111a-e063-dadaa90a10e2VITAL SYNERGY - TOENAIL FUNGUS SOLUTION / NAIL REPAIR PEN (82743-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82743-101-01TOENAIL FUNGUS / NAIL REPAIR PEN30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION303
82743-101-03TOENAIL FUNGUS / NAIL REPAIR PEN3 mL in 1 BOTTLE, WITH APPLICATORSOLUTION33
82743-101-30TOENAIL FUNGUS / NAIL REPAIR PEN1 in 1 BOXSOLUTION13
82743-101-63TOENAIL FUNGUS / NAIL REPAIR PEN6 in 1 BOXSOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82743-101TOENAIL FUNGUS / NAIL REPAIR PEN (TEA TREE OIL) SOLUTION [VITAL SYNERGY LLC]3Legacy NDC, 4 package rows20220521_df28c13e-da4a-46c9-e053-2995a90a6597.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82743-10182743-101-01, 82743-101-30, 82743-101-03, 82743-101-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GACTIB
ALMOND OIL66YXD4DKO9IACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT

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
df745cf0-42bb-15a6-e053-2995a90ace62df28c13e-da4a-46c9-e053-2995a90a65972022-05-20WarningsExact identifier
spl id: df745cf0-42bb-15a6-e053-2995a90ace62
spl set id: df28c13e-da4a-46c9-e053-2995a90a6597

Reported adverse events (FAERS/openFDA)#

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