Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 6da04ff9-4088-427c-9757-36092c8f7585
Route
TOPICAL
Published
Effective Date 2018-02-08
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 Whey Benzyl Alcohol Ethylhexylglycerin Tocopherol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Sodium Hydroxide Edetate Disodium

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-02-08

Description

Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 6X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.


Medication Information

Description

Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 6X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.

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:

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Active Ingredients:

Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 6X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.

Inactive Ingredients:

Purified Water, Whey Protein Concentrate (milk), Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Sodium Hydroxide (Solution), 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:)

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Active Ingredients: (ACTIVE INGREDIENTS:)

Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 6X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Whey Protein Concentrate (milk), Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Sodium Hydroxide (Solution), 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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