FDA.reportPublic FDA data

Injury Topical

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:16

Label at a glance#

ProductInjury Topical
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA WHOLE, HYPERICUM PERFORATUM WHOLE, COMFREY ROOT, BELLIS PERENNIS WHOLE, ACTIVATED CHARCOAL, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM WHOLE, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, VERATRUM ALBUM ROOT
Label structure9 sections

Dosage and administration

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2-3 times daily.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis MT, Arnica Montana MT, 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Bellis Perennis 12X, Carbo Vegetabilis 12X, Hamamelis Virginiana 12X, Millefolium 12X, Rhus Tox 12X, Ruta Graveolens 12X, Veratrum Album 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For bumps, bruises, abrasions, strains, sprains, fractures, stiffness. For all body and head injuries.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. If swallowed, 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.

For External Use Only.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2-3 times daily.

INDICATIONS:

INDICATIONS & USAGE SECTION

For bumps, bruises, abrasions, strains, sprains, fractures, stiffness. For all body and head injuries.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Aloe Vera Leaf Juice Extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Ethanol 3.6%.

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

INJURY TOPICAL

HOMEOPATHIC

NET WT 2 OZ (57 g)

Injury TopicalInjury Topical

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0608-12024-10-17C16284748780-1f386c64a-05ec-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0608-12023-01-30C16284748780-1f386c64a-05ec-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0608-1Injury Topical57 g in 1 TUBELOTION572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0608INJURY TOPICAL (CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUM) LOTION [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_c5ed8876-d419-41db-9af3-42d76e1c562e.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-060843857-0608-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
COMFREY ROOTM9VVZ08EKQACTIB
BELLIS PERENNIS WHOLE2HU33I03UYACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
Injury TopicalCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUMBioActive Nutritional, Inc.c5ed8876-d419-41db-9af3-42d76e1c562e2024-10-17WarningsExact identifier
ndc (package): 43857-0608-1
ndc (product): 43857-0608
ndc11 (package): 43857060801
spl id: e0b3d28d-6c2a-4c8d-8f38-4ed2f6a393b7
spl set id: c5ed8876-d419-41db-9af3-42d76e1c562e

Reported adverse events (FAERS/openFDA)#

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