Product Name & Indications Section
Prostate Formulated for symptoms associated with erectile dysfunction, benign prostatic hypertrophy, prostatitis, dysuria and other prostate related conditions.
Prostate
FDA Label NDC 55714-4464
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 Prostate (NDC 55714-4464). 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. Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional.
Active Ingredient Section
Thyroidinum 15x, Baryta carb. 10x ,Berber. vulg. 10x, Bryonia 10x, Calc. carb. 10x, Cinchona 10x ,Conium 10x, Digitalis 10x, Ferrum picricum 10x, Hydrastis 10x, Iodium 10x, Lycopodium 10x, Nux vom. 10x, Pareira 10x, Pulsatilla 10x, Sabal 10x, Selenium 10x, Staphysag. 10x, Thuja occ. 10x, Trifolium pratense 10x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.
Purpose Section
Formulated for symptoms associated with erectile dysfunction, benign prostatic hypertrophy, prostatitis, dysuria and other prostate related conditions.
Inactive Ingredient Section
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, GA30012
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, 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 (R033 L01)
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