Hemorrhoid Relief: Homeopathic Product Information

HEMORRHOID RELIEF- horse chestnut, arnica montana, calcium fluoride, milk thistle, collinsonia canadensis root, hamamelis virginiana root bark/stem bark, hydrochloric acid and krameria lappacea root 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:

Aesculus Hippocastanum 1X, Arnica Montana 3X, Calcarea Fluorica 9X, Carduus Marianus1x, Collinsonia Canadensis 3X, Hamamelis Virginiana 3X, Muriaticum Acidum 6X, Ratanhia 3X.

INDICATIONS:

Long-lasting homeopathic oral spray for the temporary relief of pain, burning and discomfort associated with hemorrhoids.†

†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 and children over 12. Spray twice under tongue 3 times per day.

Children 12 and under. Consult a doctor prior to use.

INDICATIONS:

Long-lasting homeopathic oral spray for the temporary relief of pain, burning and discomfort associated with hemorrhoids.†

†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

PACKAGE LABEL DISPLAY:

NDC# 69607-0003-1

BIOVEA

HOMEOPATHICS

Hemorrhoid Relief

Homeopathic

1 FL. OZ. (30ml)

RELIEVE DISCOMFORT†

HEMORRHOID RELIEF aesculus hippocastanum, arnica montana, calcarea fluorica, carduus marianus, collinsonia canadensis, hamamelis virginiana, muriaticum acidum, ratanhia, spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69607-0003 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORSE CHESTNUT (HORSE CHESTNUT) HORSE CHESTNUT 1 [hp_X] in 1 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 3 [hp_X] in 1 mL CALCIUM FLUORIDE (FLUORIDE ION) CALCIUM FLUORIDE 9 [hp_X] in 1 mL MILK THISTLE (MILK THISTLE) MILK THISTLE 1 [hp_X] in 1 mL COLLINSONIA CANADENSIS ROOT (COLLINSONIA CANADENSIS ROOT) COLLINSONIA CANADENSIS ROOT 3 [hp_X] in 1 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X] in 1 mL HYDROCHLORIC ACID (HYDROCHLORIC ACID) HYDROCHLORIC ACID 6 [hp_X] in 1 mL KRAMERIA LAPPACEA ROOT (KRAMERIA LAPPACEA ROOT) KRAMERIA LAPPACEA ROOT 3 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69607-0003-1 30 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/08/2015

Labeler — Biovea (089173699)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (69607-0003), api manufacture (69607-0003), label (69607-0003), pack (69607-0003)

Revised: 07/2015 Biovea