PAIN FREEDOM (calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla- smilax regelii spray

Pain Freedom by

Drug Labeling and Warnings

Pain Freedom by is a Homeopathic medication manufactured, distributed, or labeled by Amore Energia, LLC, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: sprains, minor joint inflammation, trauma.**

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

WARNINGS:

If pregnant or breastfeeding, 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.

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:

Apply a light spray over the affected area. Allow to dry. Repeat 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: sprains, minor joint inflammation, trauma.**

**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, Arnica Flower*, Chaparral Leaf*, Comfrey Leaf*, Dragon's Blood Croton Sap, English Lavender Buds*, Ionic Colloidal Silver, Lemon Balm Leaf*, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Poke Berries*, Poke Root*, Potassium Sorbate, Purified Water, Sodium Bicarbonate, St. John's Wort Aerial Parts*, Tocopherols (soy), Vitamin C, Whey Protein Concentrate (Milk), White Willow Bark* and Yarrow Flower*.
*extract

QUESTIONS:

Dist. by Amore Energia, LLC

8001 Chicago Street

Omaha, NE 68114

PACKAGE LABEL DISPLAY:

Amore Energia

Pain Freedom

Topical Homeopathic

Spray

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

PAIN FREEDOM 
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: 71166-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	12 [hp_X]  in 1 mL
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E)	CROTON TIGLIUM SEED	30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]  in 1 mL
PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR WHOLE - UNII:W2469WNO6U)	PLANTAGO MAJOR WHOLE	30 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SMILAX ORNATA ROOT - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SILVER (UNII: 3M4G523W1G)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WHEY (UNII: 8617Z5FMF6)
SALIX ALBA BARK (UNII: 205MXS71H7)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71166-0001-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/28/2017

Labeler - Amore Energia, LLC (080487870)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(71166-0001) , api manufacture(71166-0001) , label(71166-0001) , pack(71166-0001)