BACK, NECK AND SCIATIC RESCUE- phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, 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:

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Sodium Hydroxide, acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33, Peg-8 Dimethicone, Peg-14, Aloe Vera, Tocopherols, Edetate Disodium (EDTA), Natural Plant extract, Potassium Sorbate, Arnica (Flower) Arnica Montana, Comfrey (Leaf) Symphytum Officinale, Kava (Root) Piper Methysticum, Poke (Root) Phytolacca Americana, St. John’s Wort (Leaf, Flower, Stem) Hypericum Perforatum, White Willow (Bark) Salix Alba, Yarrow (Flower) Achillea Millefolium, Lavender (buds) Lavandula Angustifolia, Ascorbic Acid.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

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 Sciatic Rescue

BACK, NECK AND SCIATIC RESCUE 
phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT4 [hp_X]  in 1 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE3 [hp_X]  in 1 g
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE3 [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
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG6 [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)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OREGANO (UNII: 0E5AT8T16U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
COMFREY LEAF (UNII: DG4F8T839X)  
MACROPIPER METHYSTICUM ROOT (UNII: BOW48C81XP)  
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0076-157 g in 1 TUBE; Type 0: Not a Combination Product03/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/17/2021
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0076) , api manufacture(43846-0076) , label(43846-0076) , pack(43846-0076)

Revised: 3/2021
Document Id: 7833f2e8-ab7e-47f4-8e5d-0a2004422c1f
Set id: dc2033a7-a322-4733-8bfe-5a36fe1fa807
Version: 1
Effective Time: 20210317
 
Peaceful Mountain, Inc.