Label: SLEEP KIDS- avena sativa top, lavandula angustifolia subsp. pyrenaica whole, macropiper methysticum root, and valerian solution/ drops

  • 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 30, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    USDA Certified Organic
    Avena sativa* 12XRemedy for Sleeplessness
    Lavandula vera* 12XRemedy for Disturbed Sleep
    Piper methysticum* 12XRemedy for Difficulty Falling to Sleep
    Valeriana officinalis* 12XRemedy for Sleeplessness
  • Uses

    for assistance with occasional difficulties falling and staying asleep.

  • Warnings

    For external use only. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs. Stop use and consult a doctor if condition worsens.

    Recommended for children ages 3 to 12.

    Ask a health professional before use. If accidental ingestion and adverse reaction occurs, get medical help or contact a Poison Control Center. Keep out of reach of children.

  • Directions

    shake well before use. Roll product under nose, to the forehead, upper chest and/or back of neck. Apply upon early awakening to restore sleep.

  • Other information

    • Keep in cool dark place
    • store upright
    • tighten cap after use to prevent oxidation
  • Inactive ingredients

    Sesame Oil*, Lavandin Oil*, German Chamomile Oil*

  • Questions or comments?

    Call us at 1-877-975-3797 or visit our website www.forcesofnaturemedicine.com

  • SPL UNCLASSIFIED SECTION

    Manufactured & Distributed by Forces of Nature, Inc.
    21787 8th St East #3A Sonoma, CA 95476 USA

  • PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

    Homeopathic
    NDC #51393-5011-5

    FORCES OF NATURE®

    Sleep Well

    ORGANIC PLANT MEDICINE

    Multi-Action Support
    for Ages 3-12

    for Kids

    Promotes Restful Sleep

    Easy Roll-on Applicator

    Safe, No Side Effects

    NON
    GMO
    Project
    VERIFIED
    nongmoproject.org

    USDA
    ORGANIC

    4 ml (.14 FL OZ)

    Principal Display Panel - 4 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SLEEP KIDS 
    avena sativa top, lavandula angustifolia subsp. pyrenaica whole, macropiper methysticum root, and valerian solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-5010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avena Sativa Top (UNII: 1ZX4OXU3N6) (Avena Sativa Top - UNII:1ZX4OXU3N6) Avena Sativa Top12 [hp_X]  in 100 mL
    Lavandula Angustifolia Subsp. Pyrenaica Whole (UNII: I705WOF092) (Lavandula Angustifolia Subsp. Pyrenaica Whole - UNII:I705WOF092) Lavandula Angustifolia Subsp. Pyrenaica Whole12 [hp_X]  in 100 mL
    Macropiper Methysticum Root (UNII: BOW48C81XP) (Macropiper Methysticum Root - UNII:BOW48C81XP) Macropiper Methysticum Root12 [hp_X]  in 100 mL
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian12 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sesame Oil (UNII: QX10HYY4QV)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Chamomile Flower Oil (UNII: 60F80Z61A9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-5010-41 in 1 CARTON11/01/2022
    14 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC11/01/2022
    Labeler - Forces of Nature (050169130)
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