Muscle/Tendon Pain and Stress Relief: Homeopathic Product Information

MUSCLE/TENDON PAIN AND STRESS RELIEF- calendula officinalis flowering top, croton tiglium seed, sodium chloride, plantago major, toxicodendron pubescens leaf and smilax ornata root spray
Energique, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:

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

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.

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.

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.

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.

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

QUESTIONS:

Dist. by Energique, Inc., 201 Apple Blvd.
Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MUSCLE/TENDON

PAIN & STRESS

RELIEF

Topical Spray

1 fl. oz. (30 ml)

Muscle/Tendon Pain and Stress Relief

MUSCLE/TENDON PAIN AND STRESS RELIEF
calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0303
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 1 mL
CROTON TIGLIUM SEED (CROTON TIGLIUM SEED) CROTON TIGLIUM SEED 30 [hp_X] in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X] in 1 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 30 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 1 mL
SMILAX ORNATA ROOT (SARSAPARILLA) SMILAX ORNATA ROOT 30 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44911-0303-1 30 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 11/18/2015
Labeler — Energique, Inc. (789886132)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (44911-0303), api manufacture (44911-0303), label (44911-0303), pack (44911-0303)

Revised: 06/2020 Energique, Inc.

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