FEMALE BALANCE (FOLLICULINUM, PROGESTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]

FEMALE BALANCE (FOLLICULINUM, PROGESTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]
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NDC 43857-0180-1
Set ID 78ad2598-3e80-4571-81cb-7bd50d770153
Category HUMAN OTC DRUG LABEL
Packager BioActive Nutritional, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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

  • INGREDIENTS AND APPEARANCE
    FEMALE BALANCE 
    folliculinum, progesterone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0180
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE6 [hp_X]  in 1 mL
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0180-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0180) , api manufacture(43857-0180) , label(43857-0180) , pack(43857-0180)

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