BACK AND NECK PAIN (ACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, CIMICIFUGA RACEMOSA, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA

BACK AND NECK PAIN (ACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, CIMICIFUGA RACEMOSA, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA
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NDC 69607-0005-1
Set ID 6db82ec7-ece1-4581-8d0e-d56aa8f22201
Category HUMAN OTC DRUG LABEL
Packager Biovea
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS:

    Aconitum Napellus 200C, Arnica Montana 200C, Belladonna 6X, Cimicifuga Racemosa 6X, Euphorbium Officinarum 6X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 30X, Hypericum Perforatum 200C, Magnesia Phosphorica 10X, Phytolacca Decandra 3X, Ranunculus Bulbosus 30C, Rhus Tox 200C.

  • INDICATIONS:

    Fast-acting homeopathic oral spray for the temporary relief of lower back pain, muscle cramps, stiffness & muscle spasms associated with back pain & sciatica.†

    †These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    If symptoms persist, consult a doctor.

    If pregnant or breast feeding, ask a doctor before use.

    Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

  • DIRECTIONS:

    Adults & children over 12. Spray twice under the tongue 3 times per day. For severe symptoms, dosage may be taken up to six times the first day. Children 12 & under. Consult a doctor prior to use.

  • INDICATIONS:

    Fast-acting homeopathic oral spray for the temporary relief of lower back pain, muscle cramps, stiffness & muscle spasms associated with back pain & sciatica.†

    †These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Organic alcohol 20% v/v, purified water.

  • QUESTIONS:

    Distributed by: BIOVEA

    Dallas, TX 75202

    1-800-961-4750

    www.biovea.com

    MADE IN THE

    USA

  • PACKAGE LABEL DISPLAY:

    NDC# 69607-0005-1

    BIOVEA

    HOMEOPATHICS

    Back & Neck Pain

    Homeopathic

    1 FL. OZ. (30ml)

    NATURAL RELIEF†

    Back & Neck Pain

  • INGREDIENTS AND APPEARANCE
    BACK AND NECK PAIN 
    aconitum napellus, arnica montana, belladonna, cimicifuga racemosa, euphorbium officinarum, gelsemium sempervirens, gnaphalium polycephalum, hypericum perforatum, magnesia phosphorica, phytolacca decandra, ranunculus bulbosus, rhus tox spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69607-0005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS200 [hp_C]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_C]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 1 mL
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN6 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM30 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM200 [hp_C]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS30 [hp_C]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69607-0005-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2015
    Labeler - Biovea (089173699)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(69607-0005) , api manufacture(69607-0005) , label(69607-0005) , pack(69607-0005)

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