FDA.reportPublic FDA data

Drug Facts:

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:30

Label at a glance#

ProductTrauma plus Gel
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, HYPERICUM PERFORATUM, COMFREY ROOT, BELLIS PERENNIS, LEDUM PALUSTRE TWIG, SULFURIC ACID, CALCIUM FLUORIDE, FERROSOFERRIC PHOSPHATE, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SODIUM SULFATE
Label structure9 sections

Dosage and administration

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. For topical use only.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in gel): 2.72% of Arnica Montana 30C, Bellis Perennis 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Hypericum Perforatum 30C, Ledum Palustre 12X, Natrum Sulphuricum 30C, Rhus Tox 30X, Ruta Graveolens 30X, Sulphuricum Acidum 12X, Symphytum Officinale 6X; 0.01% of Arnica Montana 1X, Calendula Officinalis 1X, Hypericum Perforatum 1X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

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

WARNINGS:

WARNINGS SECTION

For external use only. If an adverse reaction occurs, discontinue use.

If pregnant or breast-feeding, ask a health 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. Do not expose product to extreme temperatures.

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 to 3 times daily. For topical use only.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Purified Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Sodium Hydroxide, Aloe Barbadensis 200X, Edetate Disodium (EDTA).

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMA+GEL

Net wt. 2 oz. (57 g)

Trauma+GelTrauma+Gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0466-12023-01-30C16284748780-1f386c64a-3137-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0466-1Trauma plus Gel57 g in 1 TUBEGEL573

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-046644911-0466-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ARNICA MONTANAO80TY208ZWACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
COMFREY ROOTM9VVZ08EKQACTIB
BELLIS PERENNIS2HU33I03UYACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
SULFURIC ACIDO40UQP6WCFACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SODIUM SULFATE0YPR65R21JACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT

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
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.53f4232b-23d4-48dc-aa76-175fdebfc74f2026-05-06WarningsExact identifier
ndc (package): 44911-0466-1
ndc (product): 44911-0466
ndc11 (package): 44911046601
spl id: 99572f2b-6667-460a-828f-2074e823f91f
spl set id: 53f4232b-23d4-48dc-aa76-175fdebfc74f

Reported adverse events (FAERS/openFDA)#

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