FDA.reportPublic FDA data

WART FREE

Manufacturer
PUREMEDY
Effective date
2021-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:15

Label at a glance#

ProductWART FREE
Active ingredientTHUJA OCCIDENTALIS WHOLE, SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA, PINE NEEDLE OIL (PINUS SYLVESTRIS)
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

ORGANIC SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

ORGANIC ECHINACEA ANGUSTIFOLIA (2X) HPUS

ORGANIC CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)

PINUS SYLVESTRIS (1X) HPUS (PINE RESIN)

THUJA OCCIDENT. (6X) HPUS

OTC - PURPOSE SECTION

PROPERTIES

ANTI-INFLAMMATORY

ANTI-VIRAL

SKIN PROTECTANT

SKIN PROTECTANT

RELIEF FOR SKIN ERUPTIONS OR BURNING PAIN

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH HERPETIC OUTBREAKS, COLD SORES AND CANKER SORES.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TO AFFECTED AREA 3-8 TIMES PER DAY OR AS NEEDED. MAY BE APPLIED GENITALLY. ALSO APPLY DAILY AS A PREVENTATIV MEASURE.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: ORGANIC OLIVE OIL, SAFFLOWER OIL, ORGANIC BEESWAX, BALSAM FIR, ORGANIC OREGANO OIL, ORGANIC PAU D'ARCO, ORGANIC NEEM OIL

WARNINGS SECTION

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - QUESTIONS SECTION

CUSTOMER SERVICE: 310-526-6108

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

wart 1 ozwart 1 oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52810-701-112023-01-30C16284748780-19855d018-ebe8-cd31-e053-dbdaa90ab51aWART FREE (52810-701)
52810-701-112020-06-02C16284748780-19855d018-ebe8-cd31-e053-dbdaa90ab51aWART FREE (52810-701)
52810-701-112019-11-27C16284748780-19855d018-ebe8-cd31-e053-dbdaa90ab51aWART FREE (52810-701)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-701-11WART FREE30 mL in 1 JARSALVE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-701WART FREE (SAMBUCUS NIGRA FLOWER ECHINACEA ANGUSTIFOLIA CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) THUJA OCCIDENTALIS WHOLE) SALVE [PUREMEDY]4Legacy NDC, 1 package rows20211221_f83bc6ef-5d6e-451f-83e9-4952e2940225.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
PINE NEEDLE OIL (PINUS SYLVESTRIS)ACTIVE INGREDIENT5EXL5H740Y1
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T1
THUJA OCCIDENTALIS WHOLEACTIVE INGREDIENT5HBV6WCE3N1
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
PINE NEEDLE OIL (PINUS SYLVESTRIS)ACTIVE MOIETY5EXL5H740Y1
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T1
THUJA OCCIDENTALIS WHOLEACTIVE MOIETY5HBV6WCE3N1
ABIES BALSAMEA LEAF OILINACTIVE INGREDIENT2FGT9T2SQC1
AZADIRACHTA INDICA SEED OILINACTIVE INGREDIENT4DKJ9B3K2T1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
OREGANO LEAF OILINACTIVE INGREDIENT7D0CGR40U11
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS1
TABEBUIA IMPETIGINOSA WHOLEINACTIVE INGREDIENTD65QWF35411
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-70152810-701-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
THUJA OCCIDENTALIS WHOLE5HBV6WCE3NACTIB
ABIES BALSAMEA LEAF OIL2FGT9T2SQCIACT
OREGANO LEAF OIL7D0CGR40U1IACT
TABEBUIA IMPETIGINOSA WHOLED65QWF3541IACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YACTIB
OLIVE OIL6UYK2W1W1EIACT
SAFFLOWER OIL65UEH262ISIACT
YELLOW WAX2ZA36H0S2VIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates

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
d38849c8-bc36-bc3b-e053-2a95a90a6fdcf83bc6ef-5d6e-451f-83e9-4952e29402252021-12-19WarningsExact identifier
spl id: d38849c8-bc36-bc3b-e053-2a95a90a6fdc
spl set id: f83bc6ef-5d6e-451f-83e9-4952e2940225

Reported adverse events (FAERS/openFDA)#

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