Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e9
Route
ORAL
Published
Effective Date 2023-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triticum Aestivum Whole (1 [hp_X]) Asparagus (3 [hp_X]) Berberis Vulgaris Root Bark (5 [hp_X]) Echinacea Angustifolia (6 [hp_X]) Potassium Cation (8 [hp_X]) Petroselinum Crispum (12 [hp_X]) Saw Palmetto (30 [hp_X]) Solidago Virgaurea Flowering Top (33 [hp_X]) Taraxacum Officinale (14 [hp_C]) Arctostaphylos Uva-ursi Leaf (19 [hp_C]) Agathosma Betulina Leaf (30 [hp_C]) Eupatorium Purpureum Root Pork Kidney Bryonia Alba Root Mercuric Cation Aluminum Antimony Trisulfide Silver Arsenic Cation (3+) Gold Barium Cation Beryllium Bismuth Boron Bromine Cadmium Cerium Cesium Cation Chromium Cobalt Copper Dysprosium Erbium Europium Iron Gadolinium Germanium Sesquioxide Holmium Indium Lithium Cation Magnesium Manganese Mercurius Solubilis Molybdenum Neodymium Oxide Nickel Osmium Palladium Platinum Lead Praseodymium Rhodium Nitrite Ion Samarium Selenium Tin Strontium Cation Terbium Thallium Uranium Cation (6+) Vanadium Ytterbium Oxide Zinc Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (uv, Formaldehyde Inactivated) Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated) Influenza B Virus B/austria/1359417/2021 Bvr-26 Hemagglutinin Antigen (uv, Formaldehyde Inactivated) Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (uv, Formaldehyde Inactivated) Measles Virus Botulinum Toxin Type A Escherichia Coli Proteus Vulgaris Pseudomonas Aeruginosa Proteus Morganii Salmonella Enterica Enterica Serovar Typhi Lanthanum Clostridium Perfringens Human Herpesvirus 4 Niobium Poliovirus Tantalum
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-11-16 Until 2028-09-28

Description

Triticum Aestivum MT, Asparagus Officinalis 3X, Berberis Vulgaris 3X, Echinacea 3X, Kali Muriaticum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Solidago Virgaurea 3X, Taraxacum Officinale 3X, Uva-Ursi 3X, Barosma 5X, Eupatorium Purpureum 6X, Kidney 8X, Bryonia 12X, Mercurius Corrosivus 12X, Aluminum Metallicum 12X, 30X, Antimonium Crudum 12X, 30X, Argentum Metallicum 12X, 30X, Arsenicum Album 12X, 30X, Aurum Metallicum 12X, 30X, Baryta Carbonica 12X, 30X, Beryllium Metallicum 12X, 30X, Bismuthum Metallicum 12X, 30X, Boron 12X, 30X, Bromium 12X, 30X, Cadmium Metallicum 12X, 30X, Cerium Metallicum 12X, 30X, Cesium Chloride 12X, 30X, Chromium 12X, 30X, Cobaltum Metallicum 12X, 30X, Cuprum Metallicum 12X, 30X, Dysprosium Metallicum 12X, 30X, Erbium Metallicum 12X, 30X, Europium Metallicum 12X, 30X, Ferrum Metallicum 12X, 30X, Gadolinium Metallicum 12X, 30X, Germanium Sesquioxide 12X, 30X, Holmium Metallicum 12X, 30X, Indium Metallicum 12X, 30X, Lithium Carbonicum 12X, 30X, Magnesium Metallicum 12X, 30X, Manganum Metallicum 12X, 30X, Mercurius Solubilis 12X, 30X, Molybdenum 12X, 30X, Neodymium Oxide 12X, 30X, Niccolum Metallicum 12X, 30X, Osmium Metallicum 12X, 30X, Palladium Metallicum 12X, 30X, Platinum Metallicum 12X, 30X, Plumbum Metallicum 12X, 30X, Praseodymium Metallicum 12X, 30X, Rhodium Metallicum 12X, 30X, Rubidium Nitricum 12X, 30X, Samarium Metallicum 12X, 30X, Selenium Metallicum 12X, 30X, Stannum Metallicum 12X, 30X, Strontium Carbonicum 12X, 30X, Terbium Metallicum 12X, 30X, Thallium Metallicum 12X, 30X, Uranium Nitricum 12X, 30X, Vanadium Metallicum 12X, 30X, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Influenzinum 30X, Morbillinum 30X, Botulinum 30X, 60X, Colibacillinum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, Lanthanum Metallicum 14C, Clostridium Perfringens 19C, 30C, Epstein-Barr Virus Nosode 30C, Niobium Metallicum 30C, Poliomyelitis Nosode 30C, Tantalum Metallicum 30C.

Purpose

For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.


Medication Information

Purpose

For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

Description

Triticum Aestivum MT, Asparagus Officinalis 3X, Berberis Vulgaris 3X, Echinacea 3X, Kali Muriaticum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Solidago Virgaurea 3X, Taraxacum Officinale 3X, Uva-Ursi 3X, Barosma 5X, Eupatorium Purpureum 6X, Kidney 8X, Bryonia 12X, Mercurius Corrosivus 12X, Aluminum Metallicum 12X, 30X, Antimonium Crudum 12X, 30X, Argentum Metallicum 12X, 30X, Arsenicum Album 12X, 30X, Aurum Metallicum 12X, 30X, Baryta Carbonica 12X, 30X, Beryllium Metallicum 12X, 30X, Bismuthum Metallicum 12X, 30X, Boron 12X, 30X, Bromium 12X, 30X, Cadmium Metallicum 12X, 30X, Cerium Metallicum 12X, 30X, Cesium Chloride 12X, 30X, Chromium 12X, 30X, Cobaltum Metallicum 12X, 30X, Cuprum Metallicum 12X, 30X, Dysprosium Metallicum 12X, 30X, Erbium Metallicum 12X, 30X, Europium Metallicum 12X, 30X, Ferrum Metallicum 12X, 30X, Gadolinium Metallicum 12X, 30X, Germanium Sesquioxide 12X, 30X, Holmium Metallicum 12X, 30X, Indium Metallicum 12X, 30X, Lithium Carbonicum 12X, 30X, Magnesium Metallicum 12X, 30X, Manganum Metallicum 12X, 30X, Mercurius Solubilis 12X, 30X, Molybdenum 12X, 30X, Neodymium Oxide 12X, 30X, Niccolum Metallicum 12X, 30X, Osmium Metallicum 12X, 30X, Palladium Metallicum 12X, 30X, Platinum Metallicum 12X, 30X, Plumbum Metallicum 12X, 30X, Praseodymium Metallicum 12X, 30X, Rhodium Metallicum 12X, 30X, Rubidium Nitricum 12X, 30X, Samarium Metallicum 12X, 30X, Selenium Metallicum 12X, 30X, Stannum Metallicum 12X, 30X, Strontium Carbonicum 12X, 30X, Terbium Metallicum 12X, 30X, Thallium Metallicum 12X, 30X, Uranium Nitricum 12X, 30X, Vanadium Metallicum 12X, 30X, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Influenzinum 30X, Morbillinum 30X, Botulinum 30X, 60X, Colibacillinum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, Lanthanum Metallicum 14C, Clostridium Perfringens 19C, 30C, Epstein-Barr Virus Nosode 30C, Niobium Metallicum 30C, Poliomyelitis Nosode 30C, Tantalum Metallicum 30C.

Purpose:

For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

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

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

Active Ingredients:

Triticum Aestivum MT, Asparagus Officinalis 3X, Berberis Vulgaris 3X, Echinacea 3X, Kali Muriaticum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Solidago Virgaurea 3X, Taraxacum Officinale 3X, Uva-Ursi 3X, Barosma 5X, Eupatorium Purpureum 6X, Kidney 8X, Bryonia 12X, Mercurius Corrosivus 12X, Aluminum Metallicum 12X, 30X, Antimonium Crudum 12X, 30X, Argentum Metallicum 12X, 30X, Arsenicum Album 12X, 30X, Aurum Metallicum 12X, 30X, Baryta Carbonica 12X, 30X, Beryllium Metallicum 12X, 30X, Bismuthum Metallicum 12X, 30X, Boron 12X, 30X, Bromium 12X, 30X, Cadmium Metallicum 12X, 30X, Cerium Metallicum 12X, 30X, Cesium Chloride 12X, 30X, Chromium 12X, 30X, Cobaltum Metallicum 12X, 30X, Cuprum Metallicum 12X, 30X, Dysprosium Metallicum 12X, 30X, Erbium Metallicum 12X, 30X, Europium Metallicum 12X, 30X, Ferrum Metallicum 12X, 30X, Gadolinium Metallicum 12X, 30X, Germanium Sesquioxide 12X, 30X, Holmium Metallicum 12X, 30X, Indium Metallicum 12X, 30X, Lithium Carbonicum 12X, 30X, Magnesium Metallicum 12X, 30X, Manganum Metallicum 12X, 30X, Mercurius Solubilis 12X, 30X, Molybdenum 12X, 30X, Neodymium Oxide 12X, 30X, Niccolum Metallicum 12X, 30X, Osmium Metallicum 12X, 30X, Palladium Metallicum 12X, 30X, Platinum Metallicum 12X, 30X, Plumbum Metallicum 12X, 30X, Praseodymium Metallicum 12X, 30X, Rhodium Metallicum 12X, 30X, Rubidium Nitricum 12X, 30X, Samarium Metallicum 12X, 30X, Selenium Metallicum 12X, 30X, Stannum Metallicum 12X, 30X, Strontium Carbonicum 12X, 30X, Terbium Metallicum 12X, 30X, Thallium Metallicum 12X, 30X, Uranium Nitricum 12X, 30X, Vanadium Metallicum 12X, 30X, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Influenzinum 30X, Morbillinum 30X, Botulinum 30X, 60X, Colibacillinum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, Lanthanum Metallicum 14C, Clostridium Perfringens 19C, 30C, Epstein-Barr Virus Nosode 30C, Niobium Metallicum 30C, Poliomyelitis Nosode 30C, Tantalum Metallicum 30C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActiveNutritional

RENOTOX

HOMEOPATHIC

2 FL OZ (60 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

Purpose: (PURPOSE:)

For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

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

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

Active Ingredients: (ACTIVE INGREDIENTS:)

Triticum Aestivum MT, Asparagus Officinalis 3X, Berberis Vulgaris 3X, Echinacea 3X, Kali Muriaticum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Solidago Virgaurea 3X, Taraxacum Officinale 3X, Uva-Ursi 3X, Barosma 5X, Eupatorium Purpureum 6X, Kidney 8X, Bryonia 12X, Mercurius Corrosivus 12X, Aluminum Metallicum 12X, 30X, Antimonium Crudum 12X, 30X, Argentum Metallicum 12X, 30X, Arsenicum Album 12X, 30X, Aurum Metallicum 12X, 30X, Baryta Carbonica 12X, 30X, Beryllium Metallicum 12X, 30X, Bismuthum Metallicum 12X, 30X, Boron 12X, 30X, Bromium 12X, 30X, Cadmium Metallicum 12X, 30X, Cerium Metallicum 12X, 30X, Cesium Chloride 12X, 30X, Chromium 12X, 30X, Cobaltum Metallicum 12X, 30X, Cuprum Metallicum 12X, 30X, Dysprosium Metallicum 12X, 30X, Erbium Metallicum 12X, 30X, Europium Metallicum 12X, 30X, Ferrum Metallicum 12X, 30X, Gadolinium Metallicum 12X, 30X, Germanium Sesquioxide 12X, 30X, Holmium Metallicum 12X, 30X, Indium Metallicum 12X, 30X, Lithium Carbonicum 12X, 30X, Magnesium Metallicum 12X, 30X, Manganum Metallicum 12X, 30X, Mercurius Solubilis 12X, 30X, Molybdenum 12X, 30X, Neodymium Oxide 12X, 30X, Niccolum Metallicum 12X, 30X, Osmium Metallicum 12X, 30X, Palladium Metallicum 12X, 30X, Platinum Metallicum 12X, 30X, Plumbum Metallicum 12X, 30X, Praseodymium Metallicum 12X, 30X, Rhodium Metallicum 12X, 30X, Rubidium Nitricum 12X, 30X, Samarium Metallicum 12X, 30X, Selenium Metallicum 12X, 30X, Stannum Metallicum 12X, 30X, Strontium Carbonicum 12X, 30X, Terbium Metallicum 12X, 30X, Thallium Metallicum 12X, 30X, Uranium Nitricum 12X, 30X, Vanadium Metallicum 12X, 30X, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Influenzinum 30X, Morbillinum 30X, Botulinum 30X, 60X, Colibacillinum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, Lanthanum Metallicum 14C, Clostridium Perfringens 19C, 30C, Epstein-Barr Virus Nosode 30C, Niobium Metallicum 30C, Poliomyelitis Nosode 30C, Tantalum Metallicum 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActiveNutritional

RENOTOX

HOMEOPATHIC

2 FL OZ (60 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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