Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 0e6da80d-a294-4b04-b266-77a6ab0f0603
Route
ORAL
Published
Effective Date 2021-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrangea Arborescens Root (3 [hp_X]) Saw Palmetto (4 [hp_X]) Chimaphila Umbellata (12 [hp_X]) Clematis Recta Flowering Top Conium Maculatum Flowering Top Chondrodendron Tomentosum Root Anemone Pratensis Thuja Occidentalis Leafy Twig Elymus Repens Root Delphinium Staphisagria Seed Zinc
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-04-11

Description

(in each drop): 12.46% of Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Staphysagria 12X, Thuja Occidentalis 12X, Triticum Repens 12X, Zincum Metallicum 12X; 0.10% of Chimaphila Umbellata 4X, Hydrangea Arborescens 3X, Sabal Serrulata 3X.


Medication Information

Description

(in each drop): 12.46% of Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Staphysagria 12X, Thuja Occidentalis 12X, Triticum Repens 12X, Zincum Metallicum 12X; 0.10% of Chimaphila Umbellata 4X, Hydrangea Arborescens 3X, Sabal Serrulata 3X.

Warnings:

If pregnant or breastfeeding, ask a health 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:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.868.8078

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve 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.

Active Ingredients:

(in each drop): 12.46% of Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Staphysagria 12X, Thuja Occidentalis 12X, Triticum Repens 12X, Zincum Metallicum 12X; 0.10% of Chimaphila Umbellata 4X, Hydrangea Arborescens 3X, Sabal Serrulata 3X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PROSTATONE

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.


Structured Label Content

Warnings: (WARNINGS:)

If pregnant or breastfeeding, ask a health 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:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.868.8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve 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.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 12.46% of Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Staphysagria 12X, Thuja Occidentalis 12X, Triticum Repens 12X, Zincum Metallicum 12X; 0.10% of Chimaphila Umbellata 4X, Hydrangea Arborescens 3X, Sabal Serrulata 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PROSTATONE

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (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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