Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID ac8ee81f-0af4-46d4-b63f-beeb7d120f80
Route
TOPICAL
Published
Effective Date 2022-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (12 [hp_X]) Arnica Montana Bryonia Alba Root Calendula Officinalis Flowering Top Matricaria Chamomilla Citrullus Colocynthis Fruit Pulp Hypericum Perforatum Phytolacca Americana Root Pulsatilla Pratensis Whole Toxicodendron Pubescens Leaf Comfrey Root
Inactive Ingredients
Water Glycerin Whey Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Benzyl Alcohol Salicylic Acid Sorbic Acid Methyl Gluceth-10 Lauryl Glucoside Myristyl Glucoside Polyglyceryl-10 Laurate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Jojoba Oil Lavender Oil Sodium Gluconate .alpha.-tocopherol Potassium Sorbate Sodium Benzoate Citric Acid Monohydrate Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-05-12

Description

0.09% of Aconitum Napellus 12X, Arnica Montana 12X, Bryonia (Alba) 12X, Calendula Officinalis 12X, Chamomilla 12X, Colocynthis 12X, Hypericum Perforatum 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Symphytum Officinale 12X.


Medication Information

Description

0.09% of Aconitum Napellus 12X, Arnica Montana 12X, Bryonia (Alba) 12X, Calendula Officinalis 12X, Chamomilla 12X, Colocynthis 12X, Hypericum Perforatum 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Symphytum Officinale 12X.

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 at least 3 times daily over the affected area.

Indications:

May temporarily relieve pain, soreness, swelling, stiffness, and symptoms of minor injuries.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients

0.09% of Aconitum Napellus 12X, Arnica Montana 12X, Bryonia (Alba) 12X, Calendula Officinalis 12X, Chamomilla 12X, Colocynthis 12X, Hypericum Perforatum 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Symphytum Officinale 12X.

Inactive Ingredients:

Water, Glycerin, Whey protein concentrate (milk), Benzyl alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aloe Vera leaf juice, Jojoba (Simmondsia Chinensis) Seed Oil, English Lavender (Lavandula Angustifolia) flower oil, Methyl Gluceth-10, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lauryl Glucoside, Myristyl Glucoside, Polyglyceryl-6 Laurate, Sodium Gluconate, Tocopherols (soy), Salicylic Acid, Sorbic Acid, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CARE AND 

COMFORT CREAM

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 at least 3 times daily over the affected area.

Indications: (INDICATIONS:)

May temporarily relieve pain, soreness, swelling, stiffness, and symptoms of minor injuries.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients (ACTIVE INGREDIENTS)

0.09% of Aconitum Napellus 12X, Arnica Montana 12X, Bryonia (Alba) 12X, Calendula Officinalis 12X, Chamomilla 12X, Colocynthis 12X, Hypericum Perforatum 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Symphytum Officinale 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Glycerin, Whey protein concentrate (milk), Benzyl alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aloe Vera leaf juice, Jojoba (Simmondsia Chinensis) Seed Oil, English Lavender (Lavandula Angustifolia) flower oil, Methyl Gluceth-10, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lauryl Glucoside, Myristyl Glucoside, Polyglyceryl-6 Laurate, Sodium Gluconate, Tocopherols (soy), Salicylic Acid, Sorbic Acid, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CARE AND 

COMFORT CREAM

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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