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

Key Label Information#

Active Ingredients And Purpose

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.

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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

Other Label Information

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net ~ Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

PACKAGE LABEL

Label Images#

R067 L01
R067 L01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4849-1Warts30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4849WARTS (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.]1Current NDC, Legacy NDC, 1 package rows20221220_f0328097-e5d2-3532-e053-2a95a90a93f0.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-484955714-4849-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
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
WATER059QF0KO0RIACT

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net ~ Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML