BACK AND NECK RESCUE- hypericum perforatum, phytolacca americana root, guaiacum officinale resin, ledum palustre twig and conium maculatum flowering top gel 
Apotheca Company

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 the 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 concentrate, Arnica flower, Carbomer, Comfrey leaf, Edetate disodium, Lavender buds, Natural plant extract, PEG-33 and PEG 8, Dimethicone, PEG-14, Phenoxyethanol and Caprylyl glycol and Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide, St. John's wort aerial parts, Vitamin C, Vitamin E (soy), White willow bark and Yarrow flower.

KEEP OUT OF REACH OF CHILDREN.  If swallowed, get medical help or contact a Poison Control Center right away.


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


Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579  - 888-303-3388  

www.peacefulmountain.com


peaceful mountain

THE HEIGHT OF HEALTH

organic and wild-crafted herbs

back and neck rescue

homeopathic gel

formulated in boulder, co

Net wt. 0.24 oz. (7 g)

Back and Neck Relief

BACK AND NECK RESCUE 
hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum, gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0482
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [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
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
COMFREY LEAF (UNII: DG4F8T839X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)  
SAGE (UNII: 065C5D077J)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0482-17 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/13/201101/27/2016
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0482) , api manufacture(57520-0482) , label(57520-0482) , pack(57520-0482)

Revised: 8/2015
Document Id: b12c2a2b-df93-499b-9fe2-c0e82397a0f5
Set id: 1611aaee-69dd-4ad4-bee4-8b226417b1b8
Version: 2
Effective Time: 20150827
 
Apotheca Company