FDA.reportPublic FDA data

Mole Remover

Manufacturer
King Bio Inc.
Effective date
2020-05-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:13:08

Label at a glance#

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

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

HPUS active ingredients: Equal volumes of each ingredient in 10X, 30X, and LM1 potencies. Carbo veg, Graphites, Lycopodium, Phytolacca, Thuja occ. "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE SECTION

Uses † for symptomatic treatment of moles, birthmarks, brown spots, or freckles. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

WARNINGS SECTION

Warnings

  • 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.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if symptoms persist or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

STORAGE AND HANDLING SECTION

Other information:

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Alcohol, castor oil, cedar leaf oil, frankincense oil, oregano oil, lavender oil, tea tree oil.

OTC - PURPOSE SECTION

HPUS active ingredients                                               Purpose

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

Carbo vegetabilis (10X)    birthmarks
Carbo vegetabilis (30X)    birthmarks
Carbo vegetabilis (1LM) birthmarks
Graphites (10X)......................... moles
Graphites (30X)......................... moles
Graphites (1LM) ........................ moles
Lycopodium clavatum (10X)
brown spots
Lycopodium clavatum (30X)
brown spots
Lycopodium clavatum (1LM)
brown spots
Phytolacca decandra (10X)........ moles
Phytolacca decandra (30X)........ moles
Phytolacca decandra (1LM) moles
Thuja occidentalis (10X) freckles
Thuja occidentalis (30X) freckles
Thuja occidentalis (1LM) .........freckles
*“HPUS” indicates the active ingredients
are in the official Homeopathic
Pharmacopeia of the United States.

OTC - QUESTIONS SECTION

Questions? Call 866.298.2740
King Bio, Inc. • 3 Westside Drive
Asheville, NC 28806 USA
FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mole-remover-9-300-1129.jpgmole-remover-9-300-1129.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0815-32022-01-28C16284748780-19d75b9d0-c0d0-f424-e053-dadaa90a57ceMole Remover™
57955-0815-32020-05-13C16284748780-19d75b9d0-c0d0-f424-e053-dadaa90a57ceMole Remover™
57955-0815-32020-01-31C16284748780-19d75b9d0-c0d0-f424-e053-dadaa90a57ceMole Remover™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0815-3Mole Remover1 in 1 CARTONLIQUID13
57955-0815-3Mole Remover15 mL in 1 BOTTLE, WITH APPLICATORLIQUID153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0815MOLE REMOVER (CARBO VEGETABILIS, GRAPHITES, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS) LIQUID [KING BIO INC.]3Legacy NDC, 2 package rows20200514_85f34a4a-1de4-4d49-8070-afce7fa803df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBO ANIMALISACTIVE INGREDIENT279O8I04331
GRAPHITEACTIVE INGREDIENT4QQN74LH4O1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
CARBO ANIMALISACTIVE MOIETY279O8I04331
GRAPHITEACTIVE MOIETY4QQN74LH4O1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G1
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLG1
FRANKINCENSE OILINACTIVE INGREDIENT67ZYA5T02K1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
OREGANO LEAF OILINACTIVE INGREDIENT7D0CGR40U11
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1

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
57955-081557955-0815-3

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

Source Document#

Source XML · Source PDF

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 2 · 77 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 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
f4f9ae92-8169-4e1b-8bf4-92da6e216dfa85f34a4a-1de4-4d49-8070-afce7fa803df2020-05-08WarningsExact identifier
spl id: f4f9ae92-8169-4e1b-8bf4-92da6e216dfa
spl set id: 85f34a4a-1de4-4d49-8070-afce7fa803df

Reported adverse events (FAERS/openFDA)#

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