Hemorrhoids

Hemorrhoids
SPL v1
SPL
SPL Set ID 66ffdef0-9002-5704-3f58-aae44786db4f
Route
ORAL
Published
Effective Date 2012-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Micrurus Corallinus Venom (30 [hp_X]) Horse Chestnut (15 [hp_X]) Aloe (3 [hp_X]) Arsenic Cation (3+) Bryonia Alba Root Fluoride Ion 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
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Hemorrhoids  Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

Purpose

Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.


Medication Information

Purpose

Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

Description

Hemorrhoids  Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

Package Label.

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

Questions Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for symptoms associated with hemorrhoids 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 dispensing alcohol 20%

Indications & Usage Section

Hemorrhoids  Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Elaps corallinus 30x, Aesculus hipp.15x, Aloe 15x, Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Capsicum 15x, Collinsonia 15x, Crotalus horridus 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Hypericum 15x, Lachesis 15x, Lycopodium 15x, Millefolium 15x, Naja 15x, Nux vom. 15x, Paeonia 15x, Plantago 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 15x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.

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


Structured Label Content

Package Label. (PACKAGE LABEL.)

Warnings Section (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

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Hemorrhoids  Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Elaps corallinus 30x, Aesculus hipp.15x, Aloe 15x, Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Capsicum 15x, Collinsonia 15x, Crotalus horridus 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Hypericum 15x, Lachesis 15x, Lycopodium 15x, Millefolium 15x, Naja 15x, Nux vom. 15x, Paeonia 15x, Plantago 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 15x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.

Otc Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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