FDA.reportPublic FDA data

Hemorrhoids

Manufacturer
Newton Laboratories, Inc.
Effective date
2021-01-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:41:01

Label at a glance#

ProductHemorrhoids
Active ingredientMICRURUS CORALLINUS VENOM, HORSE CHESTNUT, ALOE, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CALCIUM FLUORIDE, CAPSICUM, COLLINSONIA CANADENSIS ROOT, CROTALUS HORRIDUS HORRIDUS VENOM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYDROFLUORIC ACID, HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, ACHILLEA MILLEFOLIUM, NAJA NAJA VENOM, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, PLANTAGO MAJOR, QUERCUS ROBUR NUT, KRAMERIA LAPPACEA ROOT, VIPERA BERUS VENOM, ECHINACEA, UNSPECIFIED, SOLIDAGO VIRGAUREA FLOWERING TOP, URTICA URENS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

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.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aesculus hippocastanum 11x, Echinacea 11x, Solidago virgaurea 11x, Urtica urens 11x, Aesculus hippocastanum 20x, Aloe 20x, Arsenicum album 20x, Bryonia 20x, Calcarea fluorica 20x, Capsicum annuum 20x, Collinsonia canadensis 20x, Crotalus horridus 20x, Hamamelis virginiana 20x, Hydrofluoricum acidum 20x, Hypericum perforatum 20x, Lachesis mutus 20x, Lycopodium clavatum 20x, Millefolium 20x, Naja tripudians 20x, Nux vomica 20x, Paeonia officinalis 20x, Plantago major 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Elaps corallinus 35x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4687-12024-02-05C16284748780-1f386c649-c6ab-0266-e053-dadaa90a7c1aHemorrhoids 4687L
55714-4687-12023-01-30C16284748780-1f386c649-c6ab-0266-e053-dadaa90a7c1aHemorrhoids 4687L

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-468755714-4687-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
ALOEV5VD430YW9ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CAPSICUM00UK7646FGACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIM
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PAEONIA OFFICINALIS ROOT8R564U2E1PACTIB
PLANTAGO MAJORW2469WNO6UACTIB
QUERCUS ROBUR NUTQ7MU1F4GLYACTIB
KRAMERIA LAPPACEA ROOTP29ZH1A35ZACTIB
VIPERA BERUS VENOM0ORO6NCA4MACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
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
10a8598d-1604-9c99-e063-6294a90a0af7c6f1a68d-36cd-e69a-e053-2995a90a40bc2024-02-05WarningsExact identifier
spl set id: c6f1a68d-36cd-e69a-e053-2995a90a40bc

Reported adverse events (FAERS/openFDA)#

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