BACK, NECK AND SCIATIC RESCUE- phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, whey protein, conium maculatum gel

Back, Neck and Sciatic Rescue by

Drug Labeling and Warnings

Back, Neck and Sciatic Rescue by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Phytolacca Decandra 1X, Gnaphalium Polycephalum 3X, Hypericum Perforatum 3X, Colocynthis 6X, Gelsemium Sempervirens 6X, Guaiacum 6X, Ledum Palustre 6X, Whey Protein 6X, Conium Maculatum 30X

INDICATIONS:

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

**These statements are based upon traditional homeopathic principles. 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.

When using this product  Do not get into eyes.

Stop use and ask a doctor if  Conditions worsens  Symptoms last more than 7 days

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 at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

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

INACTIVE INGREDIENTS:

Purified Water, Vitis Vinifera (Grape) Seed Oil, Whey Protein, Lecithin (Soy), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf, Arnica Montana (Flower), Comfrey (Leaf), Jamaica Dogwood (Bark), Phytolacca Americana (Root), Hypericum Perforatum (Aerial Parts), White Willow (Bark), Achillea Millefolium (Flower), Polysorbate 20, Lavandula Angustifolia (Buds), Sodium Hydroxide (Solution), Ascorbic Acid (Vitamin C), Tocopherols (Derived From Soy Bean), Edetate Disodium (EDTA), Oregano, Potassium Sorbate

QUESTIONS:

Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579  888-303-3388
www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

back, neck and sciatic rescue

formulated in boulder, co              Net wt. 0.25 oz. (7 g)

INGREDIENTS AND APPEARANCE

BACK, NECK AND SCIATIC RESCUE 
phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, whey protein, conium maculatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	1 [hp_X]  in 1 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	3 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X]  in 1 g
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	6 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 1 g
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 1 g
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	6 [hp_X]  in 1 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GRAPE SEED OIL (UNII: 930MLC8XGG)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
PISCIDIA PISCIPULA ROOT BARK (UNII: 58JV0P12FY)
ST. JOHN'S WORT (UNII: UFH8805FKA)
SALIX ALBA BARK (UNII: 205MXS71H7)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0066-1	7 g in 1 PACKET; Type 0: Not a Combination Product	09/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/14/2016

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0066) , api manufacture(43846-0066) , label(43846-0066) , pack(43846-0066)