MENOPAUSE- agnus castus, angelica sinensis radix, apis mellifica, aralia quinquefolia, arnica montana, cimicifuga racemosa, galium aparine, glycyrrhiza glabra, oophorinum suis, sepia, thuja occidentalis, viscum album 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.

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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 30C, Sepia 30C, Thuja Occidentalis 6X, Viscum Album 3X.

INDICATIONS:

Invigorating homeopathic oral spray for the temporary relief of mood swings, hot flashes, irritability & low libido associated with hormonal menopause.†

†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 only. Spray twice under the tongue 3 times per day.

INDICATIONS:

Invigorating homeopathic oral spray for the temporary relief of mood swings, hot flashes, irritability & low libido associated with hormonal menopause.†

†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# 69607-0009-1

BIOVEA

HOMEOPATHICS

Menopause

Homeopathic

1 FL. OZ. (30ml)

WOMEN'S HEALTH

Menopause

MENOPAUSE
agnus castus, angelica sinensis radix, apis mellifica, aralia quinquefolia, arnica montana, cimicifuga racemosa, galium aparine, glycyrrhiza glabra, oophorinum suis, sepia, thuja occidentalis, viscum album spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69607-0009
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	3 [hp_X] in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	3 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X] in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	3 [hp_X] in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X] in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X] in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE	3 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	3 [hp_X] in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	30 [hp_C] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_C] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X] in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP)	VISCUM ALBUM FRUITING TOP	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69607-0009-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/02/2015	08/16/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/02/2015	08/16/2022

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(69607-0009) , api manufacture(69607-0009) , label(69607-0009) , pack(69607-0009)

Revised: 3/2022

Document Id: 198e0c8f-49c7-462c-9b96-69ea830e3d54

Set id: 983d7ce6-578c-4683-bf97-66f467be0d59

Version: 2

Effective Time: 20220309

Biovea