Hemorrhoids 4845l

Hemorrhoids 4845l
SPL v1
SPL
SPL Set ID c6f30a27-ae7f-2574-e053-2995a90a9102
Route
ORAL
Published
Effective Date 2021-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Micrurus Corallinus Venom (35 [hp_X]) Horse Chestnut (20 [hp_X]) Aloe (21 [hp_X]) Arsenic Cation (3+) (11 [hp_X]) Bryonia Alba Root Fluoride Ion Capsicum Collinsonia Canadensis Root Crotalus Horridus Horridus Venom Hamamelis Virginiana Root Bark/stem Bark 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
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-03-31

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label.

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.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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%.

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 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


Structured Label Content

Package Label. (PACKAGE LABEL.)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

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.

Otc Active Ingredient Section (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 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)