Back and Neck Pain: Homeopathic Product Information

BACK AND NECK PAIN- aconitum napellus, arnica montana, atropa belladonna, black cohosh, euphorbia resinifera resin, gelsemium sempervirens root, pseudognaphalium obtusifolium, hypericum perforatum, magnesium phosphate, dibasic trihydrate, phytolacca americana root, ranunculus bulbosus and toxicodendron pubescens leaf spray
Biovea

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.

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 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 Type HUMAN OTC DRUG Item Code (Source) NDC:69607-0005 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 200 [hp_C] in 1 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 200 [hp_C] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 6 [hp_X] in 1 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 6 [hp_X] in 1 mL EUPHORBIA RESINIFERA RESIN (EUPHORBIA RESINIFERA RESIN) EUPHORBIA RESINIFERA RESIN 6 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 30 [hp_X] in 1 mL HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 200 [hp_C] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 3 [hp_X] in 1 mL RANUNCULUS BULBOSUS (RANUNCULUS BULBOSUS) RANUNCULUS BULBOSUS 30 [hp_C] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 200 [hp_C] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69607-0005-1 30 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2015

Labeler — Biovea (089173699)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (69607-0005), api manufacture (69607-0005), label (69607-0005), pack (69607-0005)

Revised: 05/2017 Biovea