Esmenopa: Homeopathic Product Information

ESMENOPA- chaste tree, angelica sinensis root, apis mellifera, american ginseng, arnica montana, black cohosh, galium aparine, glycyrrhiza glabra, sus scrofa ovary, sepia officinalis juice, thuja occidentalis leafy twig and viscum album fruiting top spray
VitaMed, LLC

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:

Agnus Castus 3X, Angelica Sinensis Radix 3X, Apis Mellifica 6X, Aralia Quinquefolia 3X, Arnica Montana 6X, Cimicifuga Racemosa 3X, Galium Aparine 3X, Glycyrrhiza Glabra 3X, Oophorinum Suis 300C, Sepia 30C, Thuja Occidentalis 6X, Viscum ALbum 3X

INDICATIONS:

May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause: mood swings, hot flashes, irritability, vaginal dryness, lack of sexual vitality. **

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the U.S. 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 overdose, get medical help or contact a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of 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 only: Spray twice under the tongue 3 times per day.

INDICATIONS:

May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause: mood swings, hot flashes, irritability, vaginal dryness, lack of sexual vitality. **

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

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

Manufactured for VitaMed, LLC, 311 S Division St.,

Carson City, NV 89703. Phone number: (800) 270-7379

PACKAGE LABEL DISPALY

Vita Med

Esmenopa

Menopause

HOMEOPATHIC

1 FL OZ (30 ml)

ESMENOPA not applicable spray

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64249-0003 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHASTE TREE (CHASTE TREE) CHASTE TREE 3 [hp_X] in 1 mL ANGELICA SINENSIS ROOT (ANGELICA SINENSIS ROOT) ANGELICA SINENSIS ROOT 3 [hp_X] in 1 mL APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 6 [hp_X] in 1 mL AMERICAN GINSENG (AMERICAN GINSENG) AMERICAN GINSENG 3 [hp_X] in 1 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_X] in 1 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 3 [hp_X] in 1 mL GALIUM APARINE (GALIUM APARINE) GALIUM APARINE 3 [hp_X] in 1 mL GLYCYRRHIZA GLABRA (GLYCYRRHIZA GLABRA) GLYCYRRHIZA GLABRA 3 [hp_X] in 1 mL SUS SCROFA OVARY (SUS SCROFA OVARY) SUS SCROFA OVARY 30 [hp_C] in 1 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 30 [hp_C] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X] in 1 mL VISCUM ALBUM FRUITING TOP (VISCUM ALBUM FRUITING TOP) VISCUM ALBUM FRUITING TOP 3 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64249-0003-1 30 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/18/2014

Labeler — VitaMed, LLC (079364194)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (64249-0003), api manufacture (64249-0003), label (64249-0003), pack (64249-0003)

Revised: 08/2014 VitaMed, LLC