FDA.reportPublic FDA data

Varicose Veins - Phlebitis

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:59

Label at a glance#

ProductVaricose Veins - Phlebitis
Active ingredientMicrurus Corallinus Venom, Crotalus Horridus Horridus Venom, Bryonia Alba Root, Calcium Fluoride, Silybum Marianum Seed, Cholesterol, Cinchona Officinalis Bark, Digitalis, Hamamelis Virginiana Root Bark/stem Bark, Hydrofluoric Acid, Lachesis Muta Venom, Lycopodium Clavatum Spore, Naja Naja Venom, Pulsatilla Vulgaris, Vipera Berus Venom, Zinc, Horse Chestnut, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

Varicose Veins - Phlebitis  Formulated for symptoms associated with varicose veins, phlebitis, ecchymosis, spider veins and other vascular - related conditions.

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 35x, Crotalus horridus 20x, Bryonia 15x, Calc. fluor. 15x, Carduus mar. 15x, Cholesterinum 15x, Cinchona 15x, Digitalis 15x, Hamamelis 15x ,Hydrofluoricum acidum 15x, Lachesis 15x, Lycopodium 15x, Naja 15x, Pulsatilla 15x, Vipera berus 15x, Zinc. met. 15x, Aesculus hipp. 8x, Echinacea 8x, Hamamelis 8x, Aesculus hipp. 3x, Echinacea 3x, Hamamelis 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with varicose veins, phlebitis, ecchymosis, spider veins and other vascular - related conditions.

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
55714-4472-12020-01-31C16284748780-19d75b9d0-5b7b-f424-e053-dadaa90a57ceVaricose Veins - Phlebitis

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4472-1Varicose Veins - Phlebitis29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4472VARICOSE VEINS - PHLEBITIS (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.]1Legacy NDC, 1 package rows20120926_8b81500f-f062-2c86-abd2-abcf72b49345.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium FluorideACTIVE INGREDIENTO3B55K4YKI1
CholesterolACTIVE INGREDIENT97C5T2UQ7J1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9561
DigitalisACTIVE INGREDIENTF1T8QT9U8B1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS1
Horse ChestnutACTIVE INGREDIENT3C18L6RJAZ1
Hydrofluoric AcidACTIVE INGREDIENTRGL5YE86CZ1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369801
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Silybum Marianum SeedACTIVE INGREDIENTU946SH95EE1
Vipera Berus VenomACTIVE INGREDIENT0ORO6NCA4M1
ZincACTIVE INGREDIENTJ41CSQ7QDS1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
CholesterolACTIVE MOIETY97C5T2UQ7J1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9561
DigitalisACTIVE MOIETYF1T8QT9U8B1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Fluoride IonACTIVE MOIETYQ80VPU408O1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS1
Horse ChestnutACTIVE MOIETY3C18L6RJAZ1
Hydrofluoric AcidACTIVE MOIETYRGL5YE86CZ1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369801
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Silybum Marianum SeedACTIVE MOIETYU946SH95EE1
Vipera Berus VenomACTIVE MOIETY0ORO6NCA4M1
ZincACTIVE MOIETYJ41CSQ7QDS1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-447255714-4472-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Micrurus Corallinus VenomV0S6H36980ACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Bryonia Alba RootT7J046YI2BACTIB
Calcium FluorideO3B55K4YKIACTIB
Silybum Marianum SeedU946SH95EEACTIB
Cholesterol97C5T2UQ7JACTIB
Cinchona Officinalis BarkS003A158SBACTIB
DigitalisF1T8QT9U8BACTIB
Hamamelis Virginiana Root Bark/stem BarkT7S323PKJSACTIB
Hydrofluoric AcidRGL5YE86CZACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Vipera Berus Venom0ORO6NCA4MACTIB
ZincJ41CSQ7QDSACTIB
Horse Chestnut3C18L6RJAZACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
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
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 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
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 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 / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact 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
963bc3ba-c83c-6843-e0e1-ae5199cdc0b98b81500f-f062-2c86-abd2-abcf72b493452011-06-01WarningsExact identifier
spl id: 963bc3ba-c83c-6843-e0e1-ae5199cdc0b9
spl set id: 8b81500f-f062-2c86-abd2-abcf72b49345

Reported adverse events (FAERS/openFDA)#

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