FDA.reportPublic FDA data

B11

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:22

Label at a glance#

ProductB11 INJUROTOX
Active ingredientARISTOLOCHIA CYMBIFERA FLOWER, ARNICA MONTANA, ARSENIC TRIOXIDE, BELLIS PERENNIS, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, LACTIC ACID, L-, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, PRUNUS CERASIFERA FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HELIANTHEMUM NUMMULARIUM FLOWER, COMFREY ROOT, VERATRUM ALBUM ROOT, ORNITHOGALUM UMBELLATUM FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, LACHESIS MUTA VENOM, SULFUR IODIDE, BRYONIA ALBA ROOT, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER
Label structure7 sections

Dosage and administration

Adults & children ages 12 years and over: Take10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Aristolochia Milhomens

9X

Arnica Montana

4X 6X 9X 12X 15X 20X 30X 60X 100X

Arsenicum Album

9X 12X 15X 30X

Belladonna

8X

Bellis Perennis

1X

Bryonia

12X 30X

Calendula Officinalis

1X

Carbo Vegetabilis

9X 12X

Chamomilla

4X 6X 30X

Cherry Plum Flower

9X

Clematis Vitalba Flower

9X

Echinacea Angustifolia

1X

Hamamelis Virginiana

1X

Hepar Sulphuris Calcareum

10X 12X 30X

Hypericum Perforatum

3X

Impatiens Glandulifera Flower

9X

Lachesis Mutus

9X 12X 30X

Millefolium

1X

Pyrenees Star Of Bethlehem Flowering Top

9X

Rhus Toxicodendron

12X 30X

Rockrose Flower

9X

Ruta Graveolens

3X

Sarcolacticum Acidum

15X 20X 30X

Sulphur Iodatum

12X

Symphytum Officinale

2X

Veratrum Album

12X

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

joint pain*

bruises*

swelling*

headache*

muscle pain*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTHER SAFETY INFORMATION

Do not use if clear seal over the cap is broken or missing.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if joint pain, bruises, swelling, headache, muscle pain, or other symptoms do not improve within 7 days or are accompanied by fever.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults & children ages 12 years and over: Take10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® B11

ANTITOX®

INJUROTOX™

Homeopathic Formula

Joint Pain*

Bruises*

Swelling*

1 fl oz (30 mL)

Alcohol 20% by Volume

B11 Injurotox label.jpgB11 Injurotox label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0211-1B11INJUROTOX30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0211B11 INJUROTOX (ARISTOLOCHIA MILHOMENS, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, CHERRY PLUM FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER, LACHESIS MUTUS, MILLEFOLIUM, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE FLOWER, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, SYMPHYTUM OFFICINALE, VERATRUM ALBUM) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_baecce61-0514-abe5-e053-2995a90a12a8.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-021163479-0211-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARISTOLOCHIA CYMBIFERA FLOWERR06VWT372TACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BELLIS PERENNIS2HU33I03UYACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
PRUNUS CERASIFERA FLOWER0KD7R09EASACTIB
CLEMATIS VITALBA FLOWER7SCP4N87CIACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
COMFREY ROOTM9VVZ08EKQACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
ORNITHOGALUM UMBELLATUM FLOWERING TOPCZD6M4PY4BACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
BRYONIA ALBA ROOTT7J046YI2BACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB

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
B11 INJUROTOXARISTOLOCHIA MILHOMENS, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, CHERRY PLUM FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER, LACHESIS MUTUS, MILLEFOLIUM, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE FLOWER, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, SYMPHYTUM OFFICINALE, VERATRUM ALBUMApex Energetics Inc.baecce61-0514-abe5-e053-2995a90a12a82024-01-08WarningsExact identifier
ndc (package): 63479-0211-1
ndc (product): 63479-0211
ndc11 (package): 63479021101
spl id: 0e768a0e-1c52-7a5b-e063-6394a90a8097
spl set id: baecce61-0514-abe5-e053-2995a90a12a8

Reported adverse events (FAERS/openFDA)#

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