Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID b5d5c14e-b54d-49c6-aea4-df79a44d1d8d
Route
ORAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (3 [hp_X]) Comfrey Root (6 [hp_X]) Arnica Montana (12 [hp_X]) Bellis Perennis Camphor (natural) Hamamelis Virginiana Root Bark/stem Bark Hypericum Perforatum Ledum Palustre Twig Sodium Sulfate Anhydrous Phosphorus Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Delphinium Staphisagria Seed Strontium Cation
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-08-01

Description

(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

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.


Medication Information

Purpose

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.

Description

(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:

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

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.

Active Ingredients:

(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.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMATONE

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

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:)

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Directions: (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: (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.

Active Ingredients: (ACTIVE INGREDIENTS:)

(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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMATONE

1 fl. oz. (30 ml)

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.


Advanced Ingredient Data


Raw Label Data

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