Label: SLEEP WELL CONTROL- avena sativa flowering top, arabica coffee bean, lavandula angustifolia subsp. angustifolia flower, 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 April 28, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    USDA Certified Organic
    Avena sativa* 30XRemedy for Sleeplessness
    Coffea cruda* 30CRemedy for Restless Sleep
    Lavandula vera* 12CRemedy for Disturbed Sleep
    Piper methysticum* 30CRemedy for Difficulty Falling to Sleep
    Valeriana officinalis* 12CRemedy 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. Not for use on children under the age of 2 without physician direction.

    Keep out of reach of children.

    If pregnant or breast-feeding, ask a health professional before use. If accidental ingestion and adverse reaction occurs, get medical help or contact a Poison Control Center.

  • 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*, Clary Sage Oil*

  • 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 #51393-4014-4

    FORCES OF NATURE®

    CERTIFIED ORGANIC MEDICINE℠

    Sleep Well

    CONTROL Rollerball

    Roll On Sleep Aid

    • Promotes Deep Restful Sleep
    • All Natural No Adverse Side Effects
    • Helps Calm Your System
    • Fast Acting

    Salvia
    Sclarea

    USDA
    ORGANIC

    .14 OZ/4 ml Rollerball

    Principal Display Panel - 4 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SLEEP WELL   CONTROL
    avena sativa flowering top, arabica coffee bean, lavandula angustifolia subsp. angustifolia flower, macropiper methysticum root, and valerian solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-4014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avena Sativa Flowering Top (UNII: MA9CQJ3F7F) (Avena Sativa Flowering Top - UNII:MA9CQJ3F7F) Avena Sativa Flowering Top30 [hp_X]  in 100 mL
    Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean30 [hp_C]  in 100 mL
    Lavandula Angustifolia Subsp. Angustifolia Flower (UNII: 19AH1RAF4M) (Lavandula Angustifolia Subsp. Angustifolia Flower - UNII:19AH1RAF4M) Lavandula Angustifolia Subsp. Angustifolia Flower12 [hp_C]  in 100 mL
    Macropiper Methysticum Root (UNII: BOW48C81XP) (Macropiper Methysticum Root - UNII:BOW48C81XP) Macropiper Methysticum Root30 [hp_C]  in 100 mL
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian12 [hp_C]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sesame Oil (UNII: QX10HYY4QV)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Clary Sage Oil (UNII: 87L0D4U3M0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-4014-41 in 1 CARTON09/01/2018
    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 HOMEOPATHIC09/01/2018
    Labeler - Forces of Nature (050169130)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!