FEMALE BALANCE- folliculinum, progesterone liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A), PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)
Available from:
BioActive Nutritional, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of moodiness, nervousness, irritability, irregular menses, improving skin texture, restoring sexual function and improving calcium metabolism. For temporary relief of moodiness, nervousness, irritability, irregular menses, improving skin texture, restoring sexual function and improving calcium metabolism.
Authorization status:
unapproved homeopathic
Authorization number:
43857-0180-1

FEMALE BALANCE- folliculinum, progesterone liquid

BioActive Nutritional, 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.

----------

Drug Facts:

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)

FEMALE BALANCE

folliculinum, progesterone liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 57-0 18 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ESTRO NE (UNII: 2DI9 HA70 6 A) (ESTRONE - UNII:2DI9 HA70 6 A)

ESTRONE

6 [hp_X] in 1 mL

PRO GESTERO NE (UNII: 4G7DS2Q6 4Y) (PROGESTERONE - UNII:4G7DS2Q6 4Y)

PROGESTERONE

6 [hp_X] in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

WATER (UNII: 0 59 QF0 KO0 R)

BioActive Nutritional, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:438 57-0 18 0 -

30 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /24/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 8 /0 1/20 13

Labeler -

BioActive Nutritional, Inc. (624980496)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 57-0 18 0 ) , api manufacture(438 57-0 18 0 ) , label(438 57-0 18 0 ) , pack(438 57-

0 18 0 )

Revised: 10/2016

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