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

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Drug Facts:

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

Do not use if safety 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 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), 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

PACKAGE LABEL DISPLAY:

back, neck and sciatic rescue

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

formulated in boulder, co

Net wt. 2 oz. (57 g)

Back, Neck and Sciatica Rescue

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT1 [hp_X]  in 1 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM3 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 g
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]  in 1 g
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY6 [hp_X]  in 1 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP30 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
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)  
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0057-157 g in 1 TUBE; Type 0: Not a Combination Product08/04/201609/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/201609/12/2022
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0057) , api manufacture(43846-0057) , label(43846-0057) , pack(43846-0057)

Revised: 5/2018
 
Peaceful Mountain, Inc.