FDA.reportPublic FDA data

Prostatone

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2018-09-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:50:57

Label at a glance#

ProductProstatone
Active ingredientECHINACEA ANGUSTIFOLIA, PHYTOLACCA AMERICANA ROOT, SAW PALMETTO, SARSAPARILLA, SOLIDAGO VIRGAUREA FLOWERING TOP, ZINC SULFATE HEPTAHYDRATE, GOLDENSEAL, SUS SCROFA TESTICLE, SUS SCROFA PROSTATE, CLEMATIS RECTA FLOWERING TOP, PHOSPHORIC ACID, PULSATILLA VULGARIS
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

Echinacea (Angustifolia) 3X, Phytolacca Decandra 3X, Sabal Serrulata 3X, Sarsaparilla (Smilax Regelii) 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X, Hydrastis Canadensis 5X, Orchitinum (Suis) 8X, Prostate (Suis) 8X, Clematis Erecta 12X, Phosphoricum Acidum 12X, Pulsatilla (Vulgaris) 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of pain in the scrotum, testicles tender & swollen.

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.

Store in cool, dry place.

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 scrotum, testicles tender & swollen.

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

PROSTATONE

HOMEOPATHIC

1 FL OZ (30 ml)

ProstatoneProstatone

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-043243857-0432-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SARSAPARILLA2H1576D5WGACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
ZINC SULFATE HEPTAHYDRATEN57JI2K7WPACTIM
GOLDENSEALZW3Z11D0JVACTIB
SUS SCROFA TESTICLEKM02613O28ACTIB
SUS SCROFA PROSTATEO6UD3347K2ACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
7ed628de-ba46-4c10-9e5b-29acc93b3f0020485002-4971-46cd-99eb-626bf531ddd12018-09-12WarningsExact identifier
spl id: 7ed628de-ba46-4c10-9e5b-29acc93b3f00
spl set id: 20485002-4971-46cd-99eb-626bf531ddd1

Reported adverse events (FAERS/openFDA)#

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