Traumatone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
6
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, HYPERICUM PERFORATUM WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, 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): 9.99% of Arnica Montana 12X, Bellis Perennis 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Tox 12X, Ruta Graveolens 12X, Staphysagria 12X, Strontium Carbonicum 12X, Symphytum Officinale 6X; 0.10% of Calendula Officinalis 3X.

INDICATIONS:

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

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0416-12024-08-01C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:
44911-0416-12024-01-30C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:
44911-0416-12022-03-15C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:
44911-0416-12022-01-28C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0416-1Traumatone30 mL in 1 BOTTLE, DROPPERLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0416TRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUM) LIQUID [ENERGIQUE, INC.]6Current NDC, Legacy NDC, 1 package rows20240802_d4e72b3a-7336-410d-99e3-df10bcc65e75.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-041644911-0416-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUMEnergique, Inc.d4e72b3a-7336-410d-99e3-df10bcc65e752024-08-01WarningsExact identifier
ndc (package): 44911-0416-1
ndc (product): 44911-0416
ndc11 (package): 44911041601
spl id: 9df727b1-265a-48e3-ad50-feee3a962f3e
spl set id: d4e72b3a-7336-410d-99e3-df10bcc65e75

Reported adverse events (FAERS/openFDA)#

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