NATURAL PROGESTERONE- progesterone spray 
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.

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Drug Facts:

ACTIVE INGREDIENTS:

Progesterone 8X.

INDICATIONS:

For temporary relief of nervousness, irritability, moodiness, bloating, headaches, irregular menses, promotes feeling of well-being and relieves menopausal symptoms.

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 cool, dry place.

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:

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

INDICATIONS:

For temporary relief of nervousness, irritability, moodiness, bloating, headaches, irregular menses, promotes feeling of well-being and relieves menopausal symptoms.

INACTIVE INGREDIENTS:

Citric Acid, Demineralized Water, Ethanol 0.005%, Glycerin, Sodium Benzoate.

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

NATURAL PROGESTERONE

HOMEOPATHIC

1 FL OZ (30 ml)

Natural Progesterone

NATURAL PROGESTERONE 
progesterone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0084
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0084-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/09/2014
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0084) , api manufacture(43857-0084) , label(43857-0084) , pack(43857-0084)

Revised: 12/2021
Document Id: 8b849aec-1118-4097-8728-75396aa1e457
Set id: 772629aa-af5e-4493-aaf2-3c75bfd7d8c2
Version: 3
Effective Time: 20211209
 
BioActive Nutritional, Inc.