Label: CALM FIVE- clematis vitalba flos, helianthemum nummularium flos, impatiens glandulifera flos, ornithogalum umbellatum flos, prunus cerasifera flos 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 December 28, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    59.1 mL contains 20% of Clematis vitalba, flos 30C (Clematis); Helianthemum nummularium, flos 30C (Rock Rose); Impatiens glandulifera, flos 30C (Impatiens); Ornithogalum umbellatum, flos 30C (Star of Bethlehem); Prunus cerasifera, flos 30C (Cherry Plum).

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INDICATIONS & USAGE

    Uses

    Temporary relief of agitation, shock, fear.

  • WARNINGS

    Warnings
    • In case of overdose, get medical help or contact a Poison Control Center right away. 
    • If pregnant or breast-feeding, ask a healthcare professional before use.

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions
    • Take 30 drops orally twice daily or as directed by a healthcare professional. 
    • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
  • OTHER SAFETY INFORMATION

    Other information
    • Store at room temperature out of direct sunlight.
    • Do not use if neck wrap is broken or missing.
    • Shake well before use.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethyl Alcohol, Glycerin, Purified Water.

  • QUESTIONS

    Distributed by Energetix Corp.
    Dahlonega, GA 30533
    Questions? Comments?
    800.990.7085
    www.energetix.com

  • PRINCIPAL DISPLAY PANEL

    energetix

    Calm Five

    Homeopathic Remedy

    Agitation, shock, fear

    2 fl oz (59.1 mL) / 15% Ethyl Alcohol

    Calm Five r05-23

    Purpose

    Temporary relief of agitation, shock, fear.

  • INGREDIENTS AND APPEARANCE
    CALM FIVE 
    clematis vitalba flos, helianthemum nummularium flos, impatiens glandulifera flos, ornithogalum umbellatum flos, prunus cerasifera flos liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64578-0157
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER30 [hp_C]  in 59 mL
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER30 [hp_C]  in 59 mL
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER30 [hp_C]  in 59 mL
    ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM30 [hp_C]  in 59 mL
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER30 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64578-0157-159.1 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2019
    Labeler - Energetix Corp (969572502)
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