Traumatone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:27:42

Label at a glance#

ProductTraumatone
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, COMFREY ROOT, ARNICA MONTANA WHOLE, BELLIS PERENNIS WHOLE, CAMPHOR (NATURAL), HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM SULFATE, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, DELPHINIUM STAPHISAGRIA SEED, STRONTIUM CARBONATE
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 7.68% of Arnica Montana 12X, Bellis Perennis 12X, Camphora 12X, Hamamelis Virginiana 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Natrum Sulphuricum 12X, Phosphorus 12X, Rhus Tox 12X, Ruta Graveolens 12X, Staphysagria 12X, Strontium Carbonicum 12X, Symphytum Officinale 6X; 0.10% of Calendula Officinalis 3X.

PURPOSE:

OTC - PURPOSE SECTION

May temporarily relieve soreness after exertion, bruises, strains, sprains, and joint pain and stiffness.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breastfeeding, ask a health 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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve soreness after exertion, bruises, strains, sprains, and joint pain and stiffness.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

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
TRAUMATONE
1 fl. oz. (30 ml)

TRAUMATONETRAUMATONE

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0714-1Traumatone30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0714TRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, CAMPHORA, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUM) LIQUID [ENERGIQUE, INC.]1Current NDC, 1 package rows20240802_b5d5c14e-b54d-49c6-aea4-df79a44d1d8d.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-071444911-0714-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
TraumatoneCALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, CAMPHORA, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUMEnergique, Inc.b5d5c14e-b54d-49c6-aea4-df79a44d1d8d2024-08-01WarningsExact identifier
ndc (package): 44911-0714-1
ndc (product): 44911-0714
ndc11 (package): 44911071401
spl id: efa49d66-c818-44b4-918e-fe5487c27957
spl set id: b5d5c14e-b54d-49c6-aea4-df79a44d1d8d

Reported adverse events (FAERS/openFDA)#

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