Traumatone: Homeopathic Product Information

TRAUMATONE- calendula 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 and strontium carbonate liquid
Energique, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:

(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:

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:

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:

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

DIRECTIONS:

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:

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:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
TRAUMATONE
1 fl. oz. (30 ml)

Traumatone
(click image for full-size original)
TRAUMATONE
calendula officinalis, symphytum officinale, arnica montana, bellis perennis, hypericum perforatum, ledum palustre, phosphorus, rhus tox, ruta graveolens, staphysagria, strontium carbonicum liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0416
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 6 [hp_X] in 1 mL
ARNICA MONTANA WHOLE (ARNICA MONTANA) ARNICA MONTANA WHOLE 12 [hp_X] in 1 mL
BELLIS PERENNIS WHOLE (BELLIS PERENNIS) BELLIS PERENNIS WHOLE 12 [hp_X] in 1 mL
HYPERICUM PERFORATUM WHOLE (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM WHOLE 12 [hp_X] in 1 mL
RHODODENDRON TOMENTOSUM LEAFY TWIG (LEDUM PALUSTRE TWIG) RHODODENDRON TOMENTOSUM LEAFY TWIG 12 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 12 [hp_X] in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (DELPHINIUM STAPHISAGRIA SEED) DELPHINIUM STAPHISAGRIA SEED 12 [hp_X] in 1 mL
STRONTIUM CARBONATE (STRONTIUM CATION) STRONTIUM CARBONATE 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44911-0416-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/08/2017
Labeler — Energique, Inc. (789886132)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (44911-0416), api manufacture (44911-0416), label (44911-0416), pack (44911-0416)

Revised: 08/2022 Energique, Inc.

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