Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f
Route
TOPICAL
Published
Effective Date 2015-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (12 [hp_X]) Croton Tiglium Seed (30 [hp_X]) Chloride Ion Plantago Major Toxicodendron Pubescens Leaf Sarsaparilla
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Larrea Tridentata Top Comfrey Leaf Croton Lechleri Resin Lavandula Angustifolia Flower Silver Melissa Officinalis Leaf Polyethylene Glycol 1500 Peg-8 Dimethicone Polyethylene Glycol 700 Phenoxyethanol Caprylyl Glycol Sorbic Acid Phytolacca Americana Fruit Phytolacca Americana Root Potassium Sorbate Water Sodium Bicarbonate Hypericum Perforatum .alpha.-tocopherol Ascorbic Acid Whey Salix Alba Bark Achillea Millefolium Flower

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-11-18

Description

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.


Medication Information

Description

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

Warnings:

For external use only.

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 get into eyes.

If symptoms persist, consult a doctor.

Do not use if tamper evident seal is broken or missing.

Questions:

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

Directions:

Adults and children spray liberally on affected area as needed. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve pain due to inflammation caused by but not limited to the following: cramping and spasms, pulls and tears, stress and strains.**

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

Active Ingredients:

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Arnica Montana (Flower)*, Larrea Tridentata (Leaf)*, Symphytum Officinale (Leaf)*, Croton Lechleri (Sap), Lavandula Angustifolia (Buds)*, Ionic Colloidal Silver Base, Melissa Officinalis (Leaf)*, [Peg-33, Peg-8 Dimethicone, Peg-14 (Silsense Copolyol-1 Silicone)], [Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, (Optiphen-Plus)], Phytolacca Americana (Berries)*, Phytolacca Americana (Root)*, Potassium Sorbate, Purified Water, Sodium Bicarbonate, Hypericum Perforatum (Aerial Parts)*, Tocopherol [Vitamin E Oil] (Derived From Soy Bean), Vitamin C Powder (Ascorbic Acid), Whey Protein Concentrate, Salix Alba (Bark)*, Achillea Millefolium (Flower)*

*Extract

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MUSCLE/TENDON

PAIN & STRESS

RELIEF

Topical Spray

1 fl. oz. (30 ml)

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 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 get into eyes.

If symptoms persist, consult a doctor.

Do not use if tamper evident seal is broken or missing.

Questions: (QUESTIONS:)

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

Directions: (DIRECTIONS:)

Adults and children spray liberally on affected area as needed. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve pain due to inflammation caused by but not limited to the following: cramping and spasms, pulls and tears, stress and strains.**

**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 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Arnica Montana (Flower)*, Larrea Tridentata (Leaf)*, Symphytum Officinale (Leaf)*, Croton Lechleri (Sap), Lavandula Angustifolia (Buds)*, Ionic Colloidal Silver Base, Melissa Officinalis (Leaf)*, [Peg-33, Peg-8 Dimethicone, Peg-14 (Silsense Copolyol-1 Silicone)], [Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, (Optiphen-Plus)], Phytolacca Americana (Berries)*, Phytolacca Americana (Root)*, Potassium Sorbate, Purified Water, Sodium Bicarbonate, Hypericum Perforatum (Aerial Parts)*, Tocopherol [Vitamin E Oil] (Derived From Soy Bean), Vitamin C Powder (Ascorbic Acid), Whey Protein Concentrate, Salix Alba (Bark)*, Achillea Millefolium (Flower)*

*Extract

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MUSCLE/TENDON

PAIN & STRESS

RELIEF

Topical Spray

1 fl. oz. (30 ml)

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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