drug facts:

drug facts:
SPL v3
SPL
SPL Set ID 151fe63b-0dbd-4553-a29b-59af54014dbd
Route
oral
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
american ginseng (3 [hp_X]) turnera diffusa leafy twig (8 [hp_X]) centella asiatica whole (12 [hp_X]) saw palmetto thuja occidentalis leafy twig chondrodendron tomentosum root clematis recta flowering top conium maculatum flowering top juniperus virginiana twig pulsatilla vulgaris whole
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2020-05-18

Purpose

Aralia Quinquefolia – low back pain,** Clematis Erecta – painful urination,** Conium Maculatum - weak urine stream,** Damiana – hormonal support,** Hydrocotyle Asiatica – nervous debility,** Juniperus Virginiana – painful urination,** Pareira Brava – frequent urination,** Pulsatilla – kidney support,** Sabal Serrulata – overactive bladder,** Thuja Occidentalis – burning w/urination** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Aralia Quinquefolia 3X, Clematis Erecta 12X, Conium Maculatum 12X, Damiana 3X, Hydrocotyle Asiatica 3X, Juniperus Virginiana 12X, Pareira Brava 8X, Pulsatilla 12X, Sabal Serrulata 3X, Thuja Occidentalis 3X.


Medication Information

Purpose

Aralia Quinquefolia – low back pain,** Clematis Erecta – painful urination,** Conium Maculatum - weak urine stream,** Damiana – hormonal support,** Hydrocotyle Asiatica – nervous debility,** Juniperus Virginiana – painful urination,** Pareira Brava – frequent urination,** Pulsatilla – kidney support,** Sabal Serrulata – overactive bladder,** Thuja Occidentalis – burning w/urination** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Aralia Quinquefolia 3X, Clematis Erecta 12X, Conium Maculatum 12X, Damiana 3X, Hydrocotyle Asiatica 3X, Juniperus Virginiana 12X, Pareira Brava 8X, Pulsatilla 12X, Sabal Serrulata 3X, Thuja Occidentalis 3X.

Uses:

For temporary relief of pain down thighs during efforts to urinate; great straining and constant urging when urinating.**

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

Purpose:

Aralia Quinquefolia – low back pain,** Clematis Erecta – painful urination,** Conium Maculatum - weak urine stream,** Damiana – hormonal support,** Hydrocotyle Asiatica – nervous debility,** Juniperus Virginiana – painful urination,** Pareira Brava – frequent urination,** Pulsatilla – kidney support,** Sabal Serrulata – overactive bladder,** Thuja Occidentalis – burning w/urination**

**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 a 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:

Aralia Quinquefolia 3X, Clematis Erecta 12X, Conium Maculatum 12X, Damiana 3X, Hydrocotyle Asiatica 3X, Juniperus Virginiana 12X, Pareira Brava 8X, Pulsatilla 12X, Sabal Serrulata 3X, Thuja Occidentalis 3X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

PROSTOFORCE

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 down thighs during efforts to urinate; great straining and constant urging when urinating.**

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

Purpose: (PURPOSE:)

Aralia Quinquefolia – low back pain,** Clematis Erecta – painful urination,** Conium Maculatum - weak urine stream,** Damiana – hormonal support,** Hydrocotyle Asiatica – nervous debility,** Juniperus Virginiana – painful urination,** Pareira Brava – frequent urination,** Pulsatilla – kidney support,** Sabal Serrulata – overactive bladder,** Thuja Occidentalis – burning w/urination**

**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 a 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:)

Aralia Quinquefolia 3X, Clematis Erecta 12X, Conium Maculatum 12X, Damiana 3X, Hydrocotyle Asiatica 3X, Juniperus Virginiana 12X, Pareira Brava 8X, Pulsatilla 12X, Sabal Serrulata 3X, Thuja Occidentalis 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

PROSTOFORCE

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

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