Hemorrhoids

Manufacturer
Newton Laboratories, Inc.
Effective date
2021-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:38

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 difficult elimination, 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aesculus hippocastanum 6x, Echinacea 6x, Solidago virgaurea 6x, Urtica urens 6x, Aesculus hippocastanum 15x, Aloe 15x, Arsenicum album 15x, Bryonia 15x, Calcarea fluorica 15x, Capsicum annuum 15x, Collinsonia canadensis 15x, Crotalus horridus 15x, Hamamelis virginiana 15x, Hydrofluoricum acidum 15x, Hypericum perforatum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Millefolium 15x, Naja tripudians 15x, Nux vomica 15x, Paeonia officinalis 15x, Plantago major 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 16x, Elaps corallinus 30x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as difficult elimination, 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2570-1Hemorrhoids30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2570HEMORRHOIDS (ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20210709_c69eaaf5-b8d4-708b-e053-2a95a90ae6d1.zip

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
55714-257055714-2570-1

Ingredients#

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

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

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
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69eaaf5-b8d4-708b-e053-2a95a90ae6d12021-03-15WarningsExact identifier
ndc (package): 55714-2570-1
ndc (product): 55714-2570
ndc11 (package): 55714257001
spl id: c69e98f2-440d-4e73-e053-2995a90a8dcf
spl set id: c69eaaf5-b8d4-708b-e053-2a95a90ae6d1

Reported adverse events (FAERS/openFDA)#

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