ESMENOPA- not applicable 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.

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DRUG FACTS

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

ESMENOPA 
not applicable spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64249-0003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE3 [hp_X]  in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT3 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG3 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE3 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA3 [hp_X]  in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY30 [hp_C]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64249-0003-130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/18/2014
Labeler - VitaMed, LLC (079364194)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(64249-0003) , api manufacture(64249-0003) , label(64249-0003) , pack(64249-0003)

Revised: 8/2014
Document Id: 3d16d777-06ce-44c5-aa77-640e5112447d
Set id: 8ee00126-a4a7-4e67-983f-3d4a049b55a1
Version: 1
Effective Time: 20140818
 
VitaMed, LLC