Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 5f3f74e3-3772-4642-82bd-45c77a21a5c1
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Saw Palmetto (4 [hp_X]) Sarsaparilla (5 [hp_X]) Solidago Virgaurea Flowering Top (8 [hp_X]) Zinc Cation (12 [hp_X]) Phytolacca Americana Root Goldenseal Sus Scrofa Testicle Sus Scrofa Prostate Clematis Recta Flowering Top Phosphoric Acid Anemone Pulsatilla
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-08-29
Description

Clematis Erecta 12X, Echinacea 3X, Hydrastis Canadensis 5X, Orchitinum 8X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Prostate 8X, Pulsatilla 12X, Sabal Serrulata 3X, Sarsaparilla 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X.

Purpose

Clematis Erecta - itching,** Echinacea – pain or burning,** Hydrastis Canadensis – burning pain,** Orchitinum – low libido,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – aches and pains,** Prostate – low libido,** Pulsatilla – urge to urinate,** Sabal Serrulata – painful urination,** Sarsaparilla – bladder incontinence,** Solidago Virgaurea - pain,** Zincum Sulphuricum – abdomen pain** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Medication Information

Purpose

Clematis Erecta - itching,** Echinacea – pain or burning,** Hydrastis Canadensis – burning pain,** Orchitinum – low libido,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – aches and pains,** Prostate – low libido,** Pulsatilla – urge to urinate,** Sabal Serrulata – painful urination,** Sarsaparilla – bladder incontinence,** Solidago Virgaurea - pain,** Zincum Sulphuricum – abdomen pain** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Clematis Erecta 12X, Echinacea 3X, Hydrastis Canadensis 5X, Orchitinum 8X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Prostate 8X, Pulsatilla 12X, Sabal Serrulata 3X, Sarsaparilla 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X.

Uses:

For temporary relief of pain in the scrotum, testicles tender & swollen.

Purpose:

Clematis Erecta - itching,** Echinacea – pain or burning,** Hydrastis Canadensis – burning pain,** Orchitinum – low libido,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – aches and pains,** Prostate – low libido,** Pulsatilla – urge to urinate,** Sabal Serrulata – painful urination,** Sarsaparilla – bladder incontinence,** Solidago Virgaurea - pain,** Zincum Sulphuricum – abdomen pain**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions:

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients:

Clematis Erecta 12X, Echinacea 3X, Hydrastis Canadensis 5X, Orchitinum 8X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Prostate 8X, Pulsatilla 12X, Sabal Serrulata 3X, Sarsaparilla 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

PROSTATONE

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses: (USES:)

For temporary relief of pain in the scrotum, testicles tender & swollen.

Purpose: (PURPOSE:)

Clematis Erecta - itching,** Echinacea – pain or burning,** Hydrastis Canadensis – burning pain,** Orchitinum – low libido,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – aches and pains,** Prostate – low libido,** Pulsatilla – urge to urinate,** Sabal Serrulata – painful urination,** Sarsaparilla – bladder incontinence,** Solidago Virgaurea - pain,** Zincum Sulphuricum – abdomen pain**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions: (DIRECTIONS:)

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Clematis Erecta 12X, Echinacea 3X, Hydrastis Canadensis 5X, Orchitinum 8X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Prostate 8X, Pulsatilla 12X, Sabal Serrulata 3X, Sarsaparilla 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

PROSTATONE

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:00.951802 · Updated: 2026-03-14T23:17:19.778640