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Name:Female Balance
Manufacturer:Apotheca Company
Category:Homeopathic Marketed Drugs


Female Balance

FEMALE BALANCE   - progesterone and estrone spray 
Apotheca Company

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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Female Balance

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.  Consult a physician for use in children under 12 years of age.

Inactive Ingredients:  Citric Acid, Demineralized Water, Glycerin, Sodium Benzoate.


Distributed By:

BioActive Nutritional

Melbourne, FL 32935


For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935


BioActive Homeopathic

FEMALE BALANCE

1FL OZ (30 ML)

Female Balance




FEMALE BALANCE  
female balance spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0096
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROGESTERONE (PROGESTERONE) PROGESTERONE 6 [hp_X]  in 1 mL
ESTRONE (ESTRONE) ESTRONE 6 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
SODIUM BENZOATE  
CITRIC ACID MONOHYDRATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57520-0096-1 30 mL in 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/17/2010

Labeler - Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture

Revised: 05/2010 Apotheca Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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