FEMALE BALANCE- folliculinum, progesterone liquid

FEMALE BALANCE by

Drug Labeling and Warnings

FEMALE BALANCE by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Folliculinum 6X, Progesterone 6X.

INDICATIONS:

For temporary relief of moodiness, nervousness, irritability, irregular menses, improving skin texture, restoring sexual function and improving calcium metabolism.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional 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 is broken or missing.

Store in a cool, dry place.

DIRECTIONS:

Three sprays per day. Hold in mouth for two minutes.

INACTIVE INGREDIENTS:

Glycerin 40%, Sodium Benzoate 0.5%, Citric Acid 0.12%, Demineralized Water

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.

INDICATIONS:

For temporary relief of moodiness, nervousness, irritability, irregular menses, improving skin texture, restoring sexual function and improving calcium metabolism.

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

FEMALE BALANCE

HOMEOPATHIC

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

FEMALE BALANCE 
folliculinum, progesterone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0180
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A)	ESTRONE	6 [hp_X]  in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0180-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2013

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0180) , api manufacture(43857-0180) , label(43857-0180) , pack(43857-0180)