BACK AND NECK RESCUE (HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, GUAIACUM, LEDUM PALUSTRE, CONIUM MACULATUM,) GEL [APOTHECA COMPANY]

BACK AND NECK RESCUE (HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, GUAIACUM, LEDUM PALUSTRE, CONIUM MACULATUM,) GEL [APOTHECA COMPANY]
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NDC 57520-0584-1
Set ID 74af54a1-013b-4334-8076-8afd4e455a19
Category HUMAN OTC DRUG LABEL
Packager Apotheca Company
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Hypericum perforatum 3X, Phytolacca decandra 3X, Guaiacum 6X, Ledum palustre 6X, Conium maculatum 30X.


  • PURPOSE

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


  • WARNINGS

    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 worsen,  Symptoms last more than 7 days.


  • DOSAGE & ADMINISTRATION

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


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Aloe vera concentrate, Arnica flower, Carbomer, Comfrey leaf, Edetate disodium, Lavender buds, Origanum vulgare, Slavia officinalis, PEG-33, PEG-8, Dimethicone, PEG-14, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide, St. John's Wort aerial parts, Vitamin C, Vitamin E (soy), White willow bark, Yarrow flower.


  • 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.


  • INDICATIONS & USAGE

    INDICATIONS:  For the 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


  • PRINCIPAL DISPLAY PANEL

    peaceful mountain

    THE HEIGHT OF HEALTH

    back and neck rescue

    homeopathic gel

    unscented - non-greasy - no petroleum - no menthol - no animal testing

    formulated in boulder, co

    Net wt. 2 oz. (57 g)

    Back and Neck Rescue

  • INGREDIENTS AND APPEARANCE
    BACK AND NECK RESCUE 
    hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum, gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0584
    Route of AdministrationTOPICAL
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    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)  
    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 FLOWER (UNII: YQR8R0SQEA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0584-157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/08/2011
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture

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