FDA.reportPublic FDA data

Warts - Moles - Skin Tags

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:48

Label at a glance#

ProductWarts - Moles - Skin Tags
Active ingredientAntimony Trisulfide, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Causticum, Solanum Dulcamara Top, Graphite, Lycopodium Clavatum Spore, Mercuric Sulfide, Sodium Carbonate, Nitric Acid, Strychnos Nux-vomica Seed, Toxicodendron Pubescens Leaf, Juniperus Sabina Leafy Twig, Sepia Officinalis Juice, Silicon Dioxide, Delphinium Staphisagria Seed, Sulfur, Thuja Occidentalis Leafy Twig, Taraxacum Officinale
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Warts - Moles - Skin Tags  Formulated for various types of skin conditions such as warts (including genital), moles, keloids, molluscum and skin tags.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Bryonia 15x, Calc.carb. 15x, Causticum 15x, Dulcamara 15x, Graphites 15x, Lycopodium 15x, Merc. sulph. rub. 15x, Nat. carb. 15x, Nitricum ac.15x, Nux vom. 15x, Rhus toxicodendron 15x, Sabina 15x, Sepia 15x, Silicea 15x, Staphysag. 15x, Sulphur 15x, Thuja occ. 15x, Taraxacum 3x, Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for various types of skin conditions such as warts (including genital), moles, keloids, molluscum and skin tags.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2270-02020-01-31C16284748780-19d75b9cf-e75f-f424-e053-dadaa90a57ceWarts - Moles - Skin Tags
55714-2270-12020-01-31C16284748780-19d75b9cf-e75f-f424-e053-dadaa90a57ceWarts - Moles - Skin Tags
55714-2270-22020-01-31C16284748780-19d75b9cf-e75f-f424-e053-dadaa90a57ceWarts - Moles - Skin Tags

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2270-0Warts - Moles - Skin Tags.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2270-1Warts - Moles - Skin Tags29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2270-2Warts - Moles - Skin Tags59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2270WARTS - MOLES - SKIN TAGS (ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130802_1e3d851f-3515-9830-a8e9-ee6d5a1df7a4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
CausticumACTIVE INGREDIENTDD5FO1WKFU2
Delphinium Staphisagria SeedACTIVE INGREDIENT00543AP1JV2
GraphiteACTIVE INGREDIENT4QQN74LH4O2
Juniperus Sabina Leafy TwigACTIVE INGREDIENTZ5BEX9K2G12
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Mercuric SulfideACTIVE INGREDIENTZI0T668SF12
Nitric AcidACTIVE INGREDIENT411VRN1TV42
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU42
Sodium CarbonateACTIVE INGREDIENT45P3261C7T2
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
SulfurACTIVE INGREDIENT70FD1KFU702
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3752
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Antimony TrisulfideACTIVE MOIETYF79059A38U2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
CausticumACTIVE MOIETYDD5FO1WKFU2
Delphinium Staphisagria SeedACTIVE MOIETY00543AP1JV2
GraphiteACTIVE MOIETY4QQN74LH4O2
Juniperus Sabina Leafy TwigACTIVE MOIETYZ5BEX9K2G12
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Mercuric CationACTIVE MOIETYED30FJ8Y422
Nitric AcidACTIVE MOIETY411VRN1TV42
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Silicon DioxideACTIVE MOIETYETJ7Z6XBU42
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
SulfurACTIVE MOIETY70FD1KFU702
Taraxacum OfficinaleACTIVE MOIETY39981FM3752
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-227055714-2270-1, 55714-2270-2, 55714-2270-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Antimony TrisulfideF79059A38UACTIB
Bryonia Alba RootT7J046YI2BACTIB
Oyster Shell Calcium Carbonate, Crude2E32821G6IACTIB
CausticumDD5FO1WKFUACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Mercuric SulfideZI0T668SF1ACTIB
Sodium Carbonate45P3261C7TACTIB
Nitric Acid411VRN1TV4ACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Juniperus Sabina Leafy TwigZ5BEX9K2G1ACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Delphinium Staphisagria Seed00543AP1JVACTIB
Sulfur70FD1KFU70ACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Taraxacum Officinale39981FM375ACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 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
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 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
b97cc613-e333-5b7f-10be-5b425f8bc84c1e3d851f-3515-9830-a8e9-ee6d5a1df7a42011-03-01WarningsExact identifier
spl id: b97cc613-e333-5b7f-10be-5b425f8bc84c
spl set id: 1e3d851f-3515-9830-a8e9-ee6d5a1df7a4

Reported adverse events (FAERS/openFDA)#

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