FDA.reportPublic FDA data

Renotox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2021-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:25:12

Label at a glance#

ProductRenotox
Active ingredientTRITICUM AESTIVUM WHOLE, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, ECHINACEA ANGUSTIFOLIA, POTASSIUM CHLORIDE, PETROSELINUM CRISPUM, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, ARCTOSTAPHYLOS UVA-URSI LEAF, AGATHOSMA BETULINA LEAF, EUTROCHIUM PURPUREUM ROOT, PORK KIDNEY, BRYONIA ALBA ROOT, MERCURIC CHLORIDE, ALUMINUM, ANTIMONY TRISULFIDE, SILVER, ARSENIC TRIOXIDE, GOLD, BARIUM CARBONATE, BERYLLIUM, BISMUTH, BORON, BROMINE, CADMIUM, CERIUM, CESIUM CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, IRON, GADOLINIUM, GERMANIUM SESQUIOXIDE, HOLMIUM, INDIUM, LITHIUM CARBONATE, MAGNESIUM, MANGANESE, MERCURIUS SOLUBILIS, MOLYBDENUM, NEODYMIUM OXIDE, NICKEL, OSMIUM, PALLADIUM, PLATINUM, LEAD, PRASEODYMIUM, RHODIUM, RUBIDIUM NITRITE, SAMARIUM, SELENIUM, TIN, STRONTIUM CARBONATE, TERBIUM, THALLIUM, URANYL NITRATE HEXAHYDRATE, VANADIUM, YTTERBIUM OXIDE, ZINC, INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), MEASLES VIRUS, BOTULINUM TOXIN TYPE A, ESCHERICHIA COLI, PROTEUS VULGARIS, PSEUDOMONAS AERUGINOSA, PROTEUS MORGANII, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI, LANTHANUM, CLOSTRIDIUM PERFRINGENS, HUMAN HERPESVIRUS 4, NIOBIUM, POLIOVIRUS, TANTALUM
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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 SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

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

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

RENOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

RenotoxRenotox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0527-12021-12-01C16284748780-1ba0f9c33-46c5-a910-e053-dadaa90a0b85Drug Facts:
43857-0527-12021-01-29C16284748780-1ba0f9c33-46c5-a910-e053-dadaa90a0b85Drug Facts:

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 100 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-052743857-0527-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 82 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRITICUM AESTIVUM WHOLE3C3Y389JBUACTIB
ASPARAGUSZ1EJP3037ZACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIM
PETROSELINUM CRISPUM1WZA4Y92EXACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
AGATHOSMA BETULINA LEAF369DDH39Z0ACTIB
EUTROCHIUM PURPUREUM ROOT0VYG5PVN5QACTIB
PORK KIDNEYX7BCI5P86HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
ALUMINUMCPD4NFA903ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
SILVER3M4G523W1GACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
GOLD79Y1949PYOACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
BERYLLIUMOW5102UV6NACTIB
BISMUTHU015TT5I8HACTIB
BORONN9E3X5056QACTIB
BROMINESBV4XY874GACTIB
CADMIUM00BH33GNGHACTIB
CERIUM30K4522N6TACTIB
CESIUM CHLORIDEGNR9HML8BAACTIB
CHROMIUM0R0008Q3JBACTIB
COBALT3G0H8C9362ACTIB
COPPER789U1901C5ACTIB
DYSPROSIUM1D4N45714QACTIB
ERBIUM77B218D3YEACTIB
EUROPIUM444W947O8OACTIB
IRONE1UOL152H7ACTIB
GADOLINIUMAU0V1LM3JTACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
HOLMIUMW1XX32SQN1ACTIB
INDIUM045A6V3VFXACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
63c92870-a04e-483e-937b-73e1a2bda952640b02d9-d7ac-48f7-bf5e-2dd2dd4a01da2021-12-01WarningsExact identifier
spl id: 63c92870-a04e-483e-937b-73e1a2bda952
spl set id: 640b02d9-d7ac-48f7-bf5e-2dd2dd4a01da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.