Product Name & Indications Section
HEMORRHOIDS Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.
Hemorrhoids
FDA Label NDC 55714-4446
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Hemorrhoids (NDC 55714-4446). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding product name & indications section, direction section, active ingredient section, purpose section, inactive ingredient section, questions section, warnings? section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Direction 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.
Active Ingredient Section
Elaps corallinus 35x, Aesculus hipp. 20x, Aloe 20x, Arsenicum alb. 20x, Bryonia 20x, Calc. fluor. 20x, Capsicum 20x, Collinsonia 20x, Crotalus horridus 20x, Hamamelis 20x, Hydrofluoricum acidum 20x, Hypericum 20x, Lachesis 20x, Lycopodium 20x, Millefolium 20x, Naja 20x, Nux vom. 20x, Paeonia 20x, Plantago 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Aesculus hipp 8x, Echinacea 8x, Solidago 8x, Urtica ur. 8x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.
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 dispensing alcohol 20%.
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 or 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 (R024 L01)
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