FDA.reportPublic FDA data

Healthful Naturals Mole Remover

Manufacturer
Silver Star Brands
Effective date
2016-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:26

Label at a glance#

ProductHealthful Naturals Mole Remover
Active ingredientCARBO ANIMALIS, GRAPHITE, PHYTOLACCA AMERICANA ROOT, LYCOPODIUM CLAVATUM SPORE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Indications and uses

for symptomatic treatment of moles, birthmarks, brown spots, or freckles.

Dosage and administration

Shake before using. Adults and children (6-12): apply 3 times daily to affected area. It will dry and flake away over a period of 3-6 weeks.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies: Carbo vegetabilis, Graphites, Lycopodium clavatum, Phytolacca decandra, Thuja occidentalis.

Warnings

WARNINGS SECTION

  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.
  • Keep out of reach of children.
  • For external use only.
  • Avoid using near eyes or mouth.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.
  • May stain clothing.

Uses

INDICATIONS & USAGE SECTION

for symptomatic treatment of moles, birthmarks, brown spots, or freckles.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake before using.
  • Adults and children (6-12): apply 3 times daily to affected area.
  • It will dry and flake away over a period of 3-6 weeks.

Other Information

OTHER SAFETY INFORMATION

  • Intended to complement, not replace, standard medical care.
  • Tamper resistant for your protection. Use only if safety seal is intact.

Drug Facts

OTC - PURPOSE SECTION

HPUS active ingredients Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Carbo vegetabilis........................................................birthmarks

Graphites...................................................................moles

Lycopodium clavatum..................................................brown spots

Phytolacca decandra....................................................moles

Thuja occidentalis........................................................freckles

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

Alcohol, castor oil, cedar leaf oil, frankincense oil, lavender oil, oregano oil, tea tree oil

Content of Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of labelBoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-200-152020-01-31C16284748780-19d75b9d0-d83d-f424-e053-dadaa90a57ceHealthful Naturals Mole Remover

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-200-15Healthful Naturals Mole Remover15 mL in 1 BOTTLE, WITH APPLICATORLIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-200HEALTHFUL NATURALS MOLE REMOVER (CARBO VEG, GRAPHITES, LYCOPODIUM,PHYTOLACCA, THUJA OCC) LIQUID [SILVER STAR BRANDS]2Legacy NDC, 1 package rows20160109_20805e8f-f214-2a68-e054-00144ff88e88.zip

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
68703-20068703-200-15

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
CARBO ANIMALIS279O8I0433ACTIB
GRAPHITE4QQN74LH4OACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
FRANKINCENSE OIL67ZYA5T02KIACT
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ALCOHOL3K9958V90MIACT
CASTOR OILD5340Y2I9GIACT
CEDAR LEAF OILBJ169U4NLGIACT
LAVENDER OILZBP1YXW0H8IACT
OREGANO LEAF OIL7D0CGR40U1IACT
TEA TREE OILVIF565UC2GIACT

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
28d89fca-81eb-2f31-e054-00144ff88e8820805e8f-f214-2a68-e054-00144ff88e882016-01-08WarningsExact identifier
spl id: 28d89fca-81eb-2f31-e054-00144ff88e88
spl set id: 20805e8f-f214-2a68-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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