Oxyhives: Homeopathic Product Information

OXYHIVES- apis mellifera, arnica montana, pork liver, ichthammol, lachesis muta venom, mercurius solubilis, toxicodendron pubescens leaf and urtica urens spray
Global Naturals, Inc.

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:

Apis Mellifica 200C, Arnica Montana 6X, Hepar Suis 6X, Ichthyolum 6X, Lachesis Mutus 30C, Mercurius Solubilis 200C, Rhus Tox 200C, Urtica Urens 200C.

INDICATIONS:

Relieves symptoms associated with Hives.

WARNINGS:

If you are pregnant or breast-feeding, seek the advice of a doctor before use.

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

DO Not use if TAMPER EVIDENT seal around the neck of the bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Adults and children over 12, spray twice under the tongue three times per day.

For children under 12, consult a doctor prior to use.

INDICATIONS:

Relieves symptoms associated with Hives.

INACTIVE INGREDIENTS:

Alcohol 20% v/v, Purified water.

QUESTIONS:

Distributed By: Global Naturals, Inc.

PO Box 7574 Milton Keynes, MK119GQ, United Kingdom

Mon/Fri 9AM to 5PM PST 1-800-756-4120

PACKAGE LABEL DISPLAY:

OxyHives

Hives Relief

HOMEOPATHIC

1.0 FL OZ. (30 ml)

OXYHIVES apis mellifica, arnica montana, hepar suis, ichthyolum, lachesis mutus, mercurius solubilis, rhus tox, urtica urens spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43695-0010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 200 [hp_C] in 1 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_X] in 1 mL PORK LIVER (PORK LIVER) PORK LIVER 6 [hp_X] in 1 mL ICHTHAMMOL (ICHTHAMMOL) ICHTHAMMOL 6 [hp_X] in 1 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 30 [hp_C] in 1 mL MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 200 [hp_C] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 200 [hp_C] in 1 mL URTICA URENS (URTICA URENS) URTICA URENS 200 [hp_C] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43695-0010-1 30 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/26/2015

Labeler — Global Naturals, Inc. (184784283)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (43695-0010), api manufacture (43695-0010), label (43695-0010), pack (43695-0010)

Revised: 05/2016 Global Naturals, Inc.