FDA.reportPublic FDA data

Varicose Veins

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:55

Label at a glance#

ProductVaricose Veins
Active ingredientMICRURUS CORALLINUS VENOM, CROTALUS HORRIDUS HORRIDUS VENOM, BRYONIA ALBA ROOT, CALCIUM FLUORIDE, MILK THISTLE, CHOLESTEROL, CINCHONA OFFICINALIS BARK, DIGITALIS, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYDROFLUORIC ACID, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, NAJA NAJA VENOM, ANEMONE PULSATILLA, VIPERA BERUS VENOM, ZINC, HORSE CHESTNUT, ECHINACEA, UNSPECIFIED
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as swelling, discoloration, aching and heaviness in legs.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aesculus hipp. 6x, Echinacea 6x, Hamamelis 6x, Bryonia 15x, Calc. fluor. 15x, Carduus mar. 15x, Cholesterinum 15x, Cinchona 15x, Crotalus hor. 15x, Digitalis 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Lachesis 10x, Lycopodium 15x, Naja 15x, Pulsatilla 15x, Vipera berus 15x, Zinc. met. 15x, Elaps 30x.

OTC - PURPOSE SECTION

Formulated for symptoms such swelling, discoloration, aching and heaviness in legs.

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: 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
55714-4773-1Varicose Veins30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4773VARICOSE VEINS (ELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_999b04b4-ffee-3532-e053-2a95a90a0662.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-477355714-4773-1

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
ALCOHOL3K9958V90MIACT
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
MILK THISTLEU946SH95EEACTIB
CHOLESTEROL97C5T2UQ7JACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DIGITALISF1T8QT9U8BACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIM
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
VIPERA BERUS VENOM0ORO6NCA4MACTIB
ZINCJ41CSQ7QDSACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
WATER059QF0KO0RIACT

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
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.999b04b4-ffee-3532-e053-2a95a90a06622020-12-07WarningsExact identifier
ndc (package): 55714-4773-1
ndc (product): 55714-4773
ndc11 (package): 55714477301
spl id: b5e5161c-36d2-aa11-e053-2995a90a4241
spl set id: 999b04b4-ffee-3532-e053-2a95a90a0662

Reported adverse events (FAERS/openFDA)#

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