Label: MIGRAINE PAIN MANAGEMENT- iris versicolor root and sodium chloride solution/ drops

  • NDC Code(s): 51393-7588-1, 51393-7588-2, 51393-7588-4
  • Packager: Forces of Nature
  • 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 April 27, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CONTROL DRUG FACTS

  • Active Ingredients

    Iris Versicolor130C - Relieves chronic headaches and shooting pain

    Natrum Muriaticum130C - Relieves pain due to migraines


    1
    Certified Organic
  • Also Contains

    Sesame Oil1, Lavandin Oil1, Roman Chamomile Oil1, Rosemary Oil1

  • Indications

    For the temporary relief of migraine headaches.

  • Directions

    Apply to temples and back of the neck as needed, gently rub into skin. For children under 2 years of age, consult a doctor first.

  • Warnings

    Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin.

    For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast - feeding, ask a health professional before use. Not for use on children under the age of 3.

    Keep all medicines out of the reach of children.

    Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

  • SPL UNCLASSIFIED SECTION

    Manufactured & Distributed by
    FORCES OF NATURE®
    21787 8th St East #3A Sonoma, CA 95476 USA

  • PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

    ORGANIC

    NDC #51393-7588-4

    FORCES OF NATURE®
    CERTIFIED ORGANIC MEDICINESM

    Migraine
    ROLLERBALL APPLICATOR

    Topical Migraine Medicine

    • Rapid Relief for
      Acute Migraine Pain
    • Deep Penetrating Action
    • All Natural Analgesic
    • Rare Essential Oils
      by Elite Growers
      from Across
      the Planet

    Iris
    Versicolor

    .14 OZ/4 ml Rollerball

    Principal Display Panel - 4 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MIGRAINE   PAIN MANAGEMENT
    iris versicolor root and sodium chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-7588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root30 [hp_X]  in 100 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride30 [hp_C]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Chamaemelum Nobile Flower Oil (UNII: UB27587839)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Sesame Oil (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-7588-111 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2011
    2NDC:51393-7588-233 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2011
    3NDC:51393-7588-44 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/01/2011
    Labeler - Forces of Nature (050169130)