Label: TRI ESTROGEN- folliculinum, oophorinum, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 Label Information

Updated July 27, 2021

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  • ACTIVE INGREDIENTS:

     Folliculinum 6X, Oophorinum 6X.

  • INDICATIONS:

    For temporary relief of menopausal symptoms, enhances mood, sharpens thinking, improves skin texture, restores sexual function, decreases risk of arteriosclerosis.

  • 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.

  • 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 menopausal symptoms, enhances mood, sharpens thinking, improves skin texture, restores sexual function, decreases risk of arteriosclerosis.

  • INACTIVE INGREDIENTS:

    Citric Acid, Demineralized Water, Ethanol 0.1%, Glycerin, Sodium Benzoate.

  • QUESTIONS

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    TRI ESTROGEN

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Tri Estrogen

  • INGREDIENTS AND APPEARANCE
    TRI ESTROGEN 
    folliculinum, oophorinum, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE6 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0036-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2012
    Labeler - BioActive Nutritional (624980496)
    Registrant - Apotheca Company (844330912)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0036) , api manufacture(43857-0036) , label(43857-0036) , pack(43857-0036)
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