FDA.reportPublic FDA data

Warts

Manufacturer
Newton Laboratories, Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:19:00

Label at a glance#

ProductWarts
Active ingredientLYCOPODIUM 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, ANTIMONY TRISULFIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, SOLANUM DULCAMARA TOP, GRAPHITE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for moist, cauliflower-like skin growths, warty growths, skin eruptions, fig warts and smooth warts.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. WARNING: If bleeding or change in color or appearance occur, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Taraxacum 6x, Thuja occ. 6x, 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 tox 15x, Sabina 15x, Sepia 15x, Silicea 15x, Staphysag. 15x, Sulphur 15x, Thuja occ. 15x.

OTC - PURPOSE SECTION

Formulated for moist, cauliflower-like skin growths, warty growths, skin eruptions, fig warts and smooth warts.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net ~ Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: If bleeding or change in color or appearance occur, consult a licensed health professional.

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4850-1Warts28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4850WARTS (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) PELLET [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20221220_f032e7bb-a6fd-2951-e053-2a95a90a8c3a.zip

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
55714-485055714-4850-1

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
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
SUCROSEC151H8M554IACT
ANTIMONY TRISULFIDEF79059A38UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CAUSTICUMDD5FO1WKFUACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GRAPHITE4QQN74LH4OACTIB

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
WartsANTIMON. 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., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
ndc (package): 55714-4850-1
ndc (product): 55714-4850
ndc11 (package): 55714485001
spl id: f032effa-c270-9e7e-e053-2995a90a9593
spl set id: f032e7bb-a6fd-2951-e053-2a95a90a8c3a

Reported adverse events (FAERS/openFDA)#

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