BACK AND NECK RESCUE- hypericum perforatum, phytolacca decandra, 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

Hypericum Perforatum 3X, Phytolacca Decandra 3X, Guaiacum 6X, Ledum Palustre 6X, Conium Maculatum 30X

INDICATIONS

For temporary relief of minor symptoms of back and neck discomfort.

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 Condition worsens Symptoms last more than 7 days.

DIRECTIONS

Apply at least 3 times daily over the affected area. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS

Aloe Vera, Arnica Montana (flower), Carbomer (Ultrez 21), Comfrey (leaf), Edetate Disodium, Lavender (buds), Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly Glycol, Sorbic Acid, Potassium Sorbate, Water, Sodium Hydroxide Solution, Hypericum Perforatum, Ascorbic Acid, Vitamin E Oil, Salix Alba (bark), Achillea Millefolium (flower)

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

For temporary relief of minor symptoms of back and neck discomfort.

QUESTIONS

Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579

888-303-3388 www.peacefulmountain.com

back and neck rescue

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben free

formulated in boulder, co

Net wt. 3.7 oz (105 g)

Back and Neck

BACK AND NECK RESCUE
hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43846-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [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
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
OREGANO (UNII: 0E5AT8T16U)
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)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0003-1	105 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2013	04/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/20/2013	04/14/2022

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0003) , api manufacture(43846-0003) , label(43846-0003) , pack(43846-0003)

Revised: 12/2021

Document Id: 2c000e7f-1c47-45b5-8927-c0b04bb446d4

Set id: c0ee44ce-16b9-4ce5-8a98-e83f69c58776

Version: 2

Effective Time: 20211213

Peaceful Mountain, Inc.