The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritional, Inc. for the product Prostatone (NDC 43857-0492). 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 active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Echinacea (Angustifolia) 3X, Sabal Serrulata 3X, Sarsaparilla (Smilax Regelii) 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Orchitinum (Suis) 8X, Prostate (Suis) 8X, Clematis Erecta 12X, Phosphoricum Acidum 12X, Pulsatilla (Vulgaris) 12X.
For temporary relief of pain in the scrotum, testicles tender & swollen.
For temporary relief of pain in the scrotum, testicles tender & swollen.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in cool, dry place.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Demineralized Water, 25% Ethanol
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
BIOActive Nutritional
PROSTATONE
HOMEOPATHIC
1 FL OZ (30 ml)
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