Label: HEADACHE PAIN MANAGEMENT- iris versicolor root, lavandula angustifolia flowering top, and silicon dioxide solution/ drops

  • NDC Code(s): 51393-7577-1, 51393-7577-2, 51393-7577-4
  • 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 September 12, 2019

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients
    *
    USDA Certified Organic
    Iris Versicolor* 30C - Remedy for Headaches
    Lavandula Vera* 12X - Remedy for Headaches and Lack of Focus
    Silicea* 30C - Relieves Inflammation and Pressure
  • Also Contains

    Sesame Oil*, Lavandin Oil*, Rosemary Oil*

  • Indications

    For the temporary relief of headaches.

  • Directions

    Shake well before use. Apply to temples and back of the neck as needed, roll gently into the skin. For children under 2 years of age, consult a doctor before use.

  • 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 2 without physician direction.

    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.

  • Tips For Use

    Headache Pain Management works by calming the system, helping to reduce inflammation. It helps relax muscles in your head and neck that can cause or prolong headaches.

    It can offer complete relief from headache pain in as little as 3-5 minutes.

    Headache Pain Management should be applied whenever you experience symptoms or pain. Simply apply 1-3 drops to the back of your neck and temples using your fingertip, or a cotton swab.

    It is OK to use more than this to treat more severe headaches, or quicker relief. It is safe to use other headache products at the same time as Headache Pain Management.

  • 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

    Homeopathic
    NDC #51393-7577-4

    FORCES OF NATURE®

    CERTIFIED ORGANIC MEDICINE℠

    Headache

    ROLLERBALL APPLICATOR

    Topical Headache Medicine

    • Fast Relief from Tension
      and Sinus Headaches
    • Naturally occurring Anti-Inflammatory
      and Analgesic effect
    • Safe Pain Relief Without Harmful
      Side Effects
    • Rare Essential Oils
      by Elite Growers
      from Across
      the Planet

    Lavendula
    Vera

    USDA
    ORGANIC

    .14 OZ/4 ml Rollerball

    PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HEADACHE   PAIN MANAGEMENT
    iris versicolor root, lavandula angustifolia flowering top, and silicon dioxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-7577
    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_C]  in 1000 mL
    Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P) (Lavandula Angustifolia Subsp. Angustifolia Flowering Top - UNII:9YT4B71U8P) Lavandula Angustifolia Subsp. Angustifolia Flowering Top12 [hp_X]  in 1000 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide30 [hp_C]  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Lavandin Oil (UNII: 9RES347CKG)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Sesame Oil (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-7577-44 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/15/2017
    2NDC:51393-7577-111 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2011
    3NDC:51393-7577-233 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/01/2011
    Labeler - Forces of Nature (050169130)