Label: SPRAYOLOGY MENOPOWER- arnica montana, glonoinum, lachesis mutus, oophorinum, salvia officinalis, sanguinaria canadensis, sepia liquid

  • 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 29, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients: Arnica montana 200C, Glonoinum 200C, Lachesis mutus 200C, Oophorinum 30C, Salvia officinalis 2X, Sanguinaria canadensis 200C, Sepia 200C

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    • For adult women only. 2 sprays into the mouth 3 times per day.
  • PURPOSE

    Temporarily relieves common menopausal symptoms associated with hormonal imbalances, including:

    • emotional fluctuations
    • hot flashes and night sweats
    • irritability
    • vaginal dryness

  • OTHER SAFETY INFORMATION

    Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v purified water.

  • INDICATIONS & USAGE

    Temporarily relieves common menopausal symptoms associated with hormonal imbalances, including:

    ° emotional fluctuations

    ° hot flashes and night sweats

    ° irritability

    ° vaginal dryness

    ° natural

    ° gluten free

    ° no artificial flavors or colors

    ° no known negative side effects

    ° no known negative drug interactions

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPRAYOLOGY MENOPOWER 
    arnica montana, glonoinum, lachesis mutus, oophorinum, salvia officinalis, sanguinaria canadensis, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-1014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_C]  in 41 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN200 [hp_C]  in 41 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM200 [hp_C]  in 41 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY30 [hp_C]  in 41 mL
    SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE2 [hp_X]  in 41 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT200 [hp_C]  in 41 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE200 [hp_C]  in 41 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61096-1014-11 in 1 CARTON07/29/2016
    141 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/29/2016
    Labeler - Eight and Company (927364120)
    Registrant - Eight and Company (927364120)
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