Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 53f4232b-23d4-48dc-aa76-175fdebfc74f
Route
TOPICAL
Published
Effective Date 2021-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Arnica Montana (6 [hp_X]) Hypericum Perforatum (12 [hp_X]) Comfrey Root (30 [hp_X]) Bellis Perennis (30 [hp_C]) Ledum Palustre Twig Sulfuric Acid Fluoride Ion Ferrosoferric Phosphate Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Sodium Sulfate Anhydrous
Inactive Ingredients
Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Benzyl Alcohol Ethylhexylglycerin Tocopherol Sodium Hydroxide Edetate Disodium

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-08-20

Description

(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.


Medication Information

Description

(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.

Warnings:

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

Directions:

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

Indications:

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.

Active Ingredients:

(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.

Inactive Ingredients:

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

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMA+GEL

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

Directions: (DIRECTIONS:)

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

Indications: (INDICATIONS:)

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.

Active Ingredients: (ACTIVE INGREDIENTS:)

(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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMA+GEL

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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