RENOTOX- triticum aestivum, asparagus officinalis, berberis vulgaris, echinacea (angustifolia), kali muriaticum, petroselinum sativum, sabal serrulata, solidago virgaurea, taraxacum officinale, uva-ursi, barosma (betulina), eupatorium purpureum, kidney (suis), bryonia (alba), mercurius corrosivus, aluminum metallicum, antimonium crudum, argentum metallicum, arsenicum album, aurum metallicum, baryta carbonica, beryllium metallicum, bismuthum metallicum, boron, bromium, cadmium metallicum, cerium metallicum, liquid 
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

Triticum Aestivum MT, Asparagus Officinalis 3X, Berberis Vulgaris 3X, Echinacea (Angustifolia) 3X, Kali Muriaticum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Solidago Virgaurea 3X, Taraxacum Officinale 3X, Uva-Ursi 3X, Barosma (Betulina) 5X, Eupatorium Purpureum 6X, Kidney (Suis) 8X, Bryonia (Alba) 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, 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, 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 Metallicum 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, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Influenzinum 30X, Morbillinum 30X, Botulinum 30X, 60X, Escherichia Coli 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Proteus (Morgani) 30X, 60X, Salmonella Typhi Nosode 33X, Lanthanum Metallicum 14C, Clostridium Perfringens 15C, 30C, Epstein-Barr Virus Nosode 30C,Niobium Metallicum 30C, Poliomyelitis Nosode 30C, Tantalum Metallicum 30C.

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.

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.

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.

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.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

RENOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

Renotox

RENOTOX 
triticum aestivum, asparagus officinalis, berberis vulgaris, echinacea (angustifolia), kali muriaticum, petroselinum sativum, sabal serrulata, solidago virgaurea, taraxacum officinale, uva-ursi, barosma (betulina), eupatorium purpureum, kidney (suis), bryonia (alba), mercurius corrosivus, aluminum metallicum, antimonium crudum, argentum metallicum, arsenicum album, aurum metallicum, baryta carbonica, beryllium metallicum, bismuthum metallicum, boron, bromium, cadmium metallicum, cerium metallicum, liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE1 [hp_X]  in 1 mL
ASPARAGUS (UNII: Z1EJP3037Z) (ASPARAGUS - UNII:Z1EJP3037Z) ASPARAGUS3 [hp_X]  in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION3 [hp_X]  in 1 mL
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM3 [hp_X]  in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO3 [hp_X]  in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]  in 1 mL
AGATHOSMA BETULINA LEAF (UNII: 369DDH39Z0) (AGATHOSMA BETULINA LEAF - UNII:369DDH39Z0) AGATHOSMA BETULINA LEAF5 [hp_X]  in 1 mL
EUTROCHIUM PURPUREUM ROOT (UNII: 0VYG5PVN5Q) (EUPATORIUM PURPUREUM ROOT - UNII:0VYG5PVN5Q) EUTROCHIUM PURPUREUM ROOT6 [hp_X]  in 1 mL
PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H) PORK KIDNEY8 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE12 [hp_X]  in 1 mL
ALUMINUM (UNII: CPD4NFA903) (ALUMINUM - UNII:CPD4NFA903) ALUMINUM12 [hp_X]  in 1 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE12 [hp_X]  in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_X]  in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE12 [hp_X]  in 1 mL
BERYLLIUM (UNII: OW5102UV6N) (BERYLLIUM - UNII:OW5102UV6N) BERYLLIUM12 [hp_X]  in 1 mL
BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH12 [hp_X]  in 1 mL
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON12 [hp_X]  in 1 mL
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE12 [hp_X]  in 1 mL
CADMIUM (UNII: 00BH33GNGH) (CADMIUM - UNII:00BH33GNGH) CADMIUM12 [hp_X]  in 1 mL
CERIUM (UNII: 30K4522N6T) (CERIUM - UNII:30K4522N6T) CERIUM12 [hp_X]  in 1 mL
CESIUM CHLORIDE (UNII: GNR9HML8BA) (CESIUM CATION - UNII:LCC4BG14DM) CESIUM CHLORIDE12 [hp_X]  in 1 mL
CHROMIUM (UNII: 0R0008Q3JB) (CHROMIUM - UNII:0R0008Q3JB) CHROMIUM12 [hp_X]  in 1 mL
COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT12 [hp_X]  in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [hp_X]  in 1 mL
DYSPROSIUM (UNII: 1D4N45714Q) (DYSPROSIUM - UNII:1D4N45714Q) DYSPROSIUM12 [hp_X]  in 1 mL
ERBIUM (UNII: 77B218D3YE) (ERBIUM - UNII:77B218D3YE) ERBIUM12 [hp_X]  in 1 mL
EUROPIUM (UNII: 444W947O8O) (EUROPIUM - UNII:444W947O8O) EUROPIUM12 [hp_X]  in 1 mL
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON12 [hp_X]  in 1 mL
GADOLINIUM (UNII: AU0V1LM3JT) (GADOLINIUM - UNII:AU0V1LM3JT) GADOLINIUM12 [hp_X]  in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE12 [hp_X]  in 1 mL
HOLMIUM (UNII: W1XX32SQN1) (HOLMIUM - UNII:W1XX32SQN1) HOLMIUM12 [hp_X]  in 1 mL
INDIUM (UNII: 045A6V3VFX) (INDIUM - UNII:045A6V3VFX) INDIUM12 [hp_X]  in 1 mL
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE12 [hp_X]  in 1 mL
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM12 [hp_X]  in 1 mL
MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P) MANGANESE12 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM12 [hp_X]  in 1 mL
NEODYMIUM OXIDE (UNII: AYT3H319PN) (NEODYMIUM OXIDE - UNII:AYT3H319PN) NEODYMIUM OXIDE12 [hp_X]  in 1 mL
NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267) NICKEL12 [hp_X]  in 1 mL
OSMIUM (UNII: 2E7M255OPY) (OSMIUM - UNII:2E7M255OPY) OSMIUM12 [hp_X]  in 1 mL
PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM12 [hp_X]  in 1 mL
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM12 [hp_X]  in 1 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD12 [hp_X]  in 1 mL
PRASEODYMIUM (UNII: NKN7EZA750) (PRASEODYMIUM - UNII:NKN7EZA750) PRASEODYMIUM12 [hp_X]  in 1 mL
RHODIUM (UNII: DMK383DSAC) (RHODIUM - UNII:DMK383DSAC) RHODIUM12 [hp_X]  in 1 mL
RUBIDIUM NITRITE (UNII: 93722E7JA1) (RUBIDIUM CATION - UNII:PR87B22TGJ, NITRITE ION - UNII:J39976L608) RUBIDIUM NITRITE12 [hp_X]  in 1 mL
SAMARIUM (UNII: 42OD65L39F) (SAMARIUM - UNII:42OD65L39F) SAMARIUM12 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM12 [hp_X]  in 1 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN12 [hp_X]  in 1 mL
STRONTIUM CARBONATE (UNII: 41YPU4MMCA) (STRONTIUM CATION - UNII:37077S2C93) STRONTIUM CARBONATE12 [hp_X]  in 1 mL
TERBIUM (UNII: 06SSF7P179) (TERBIUM - UNII:06SSF7P179) TERBIUM12 [hp_X]  in 1 mL
THALLIUM (UNII: AD84R52XLF) (THALLIUM - UNII:AD84R52XLF) THALLIUM12 [hp_X]  in 1 mL
URANYL NITRATE HEXAHYDRATE (UNII: 3V057702FY) (URANIUM CATION (6+) - UNII:5PI36AS4G7) URANYL NITRATE HEXAHYDRATE12 [hp_X]  in 1 mL
VANADIUM (UNII: 00J9J9XKDE) (VANADIUM - UNII:00J9J9XKDE) VANADIUM12 [hp_X]  in 1 mL
YTTERBIUM OXIDE (UNII: T66CZ53RP4) (YTTERBIUM OXIDE - UNII:T66CZ53RP4) YTTERBIUM OXIDE12 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: Q3P251C5MT) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:LD80H821HF) INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)30 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 2ZSC17SIJ6) (INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:1R31M8U8H9) INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)30 [hp_X]  in 1 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8V4458342X) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:OES3CXI7E9) INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED)30 [hp_X]  in 1 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: B93BQX9789) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:9HB0XUS9TM) INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)30 [hp_X]  in 1 mL
MEASLES VIRUS (UNII: HT3R7C012Q) (MEASLES VIRUS - UNII:HT3R7C012Q) MEASLES VIRUS30 [hp_X]  in 1 mL
BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (BOTULINUM TOXIN TYPE A - UNII:E211KPY694) BOTULINUM TOXIN TYPE A30 [hp_X]  in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI30 [hp_X]  in 1 mL
PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O) PROTEUS VULGARIS30 [hp_X]  in 1 mL
PSEUDOMONAS AERUGINOSA (UNII: Y793W5V55N) (PSEUDOMONAS AERUGINOSA - UNII:Y793W5V55N) PSEUDOMONAS AERUGINOSA30 [hp_X]  in 1 mL
PROTEUS MORGANII (UNII: 56X6LID5ZY) (PROTEUS MORGANII - UNII:56X6LID5ZY) PROTEUS MORGANII30 [hp_X]  in 1 mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI33 [hp_X]  in 1 mL
LANTHANUM (UNII: 6I3K30563S) (LANTHANUM - UNII:6I3K30563S) LANTHANUM14 [hp_C]  in 1 mL
CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E) CLOSTRIDIUM PERFRINGENS15 [hp_C]  in 1 mL
HUMAN HERPESVIRUS 4 (UNII: 2A26YW7PNX) (HUMAN HERPESVIRUS 4 - UNII:2A26YW7PNX) HUMAN HERPESVIRUS 430 [hp_C]  in 1 mL
NIOBIUM (UNII: 05175J654G) (NIOBIUM - UNII:05175J654G) NIOBIUM30 [hp_C]  in 1 mL
POLIOVIRUS (UNII: FZJ641678T) (POLIOVIRUS - UNII:FZJ641678T) POLIOVIRUS30 [hp_C]  in 1 mL
TANTALUM (UNII: 6424HBN274) (TANTALUM - UNII:6424HBN274) TANTALUM30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0527-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/13/201912/03/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/13/201912/03/2024
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0527) , api manufacture(43857-0527) , label(43857-0527) , pack(43857-0527)

Revised: 12/2021
Document Id: 63c92870-a04e-483e-937b-73e1a2bda952
Set id: 640b02d9-d7ac-48f7-bf5e-2dd2dd4a01da
Version: 2
Effective Time: 20211201
 
BioActive Nutritional, Inc.