Label: RESCUE SLEEP- helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower solution

  • NDC Code(s): 57687-242-07, 57687-242-20
  • Packager: Nelson Bach USA, Ltd.
  • 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 October 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    Each 5X (HPUS)    		Purpose
    White Chestnut
    (Aesculus hippocastanum)    		Relief from repetitive thoughts
    Rock Rose
    (Helianthemum nummularium)    		Courage and presence of mind
    Clematis
    (Clematis vitalba)    		Focus when ungrounded
    Impatiens
    (Impatiens glandulifera)    		Patience with problems and people
    Cherry Plum
    (Prunus cerasifera)    		Balanced mind when losing control
    Star of Bethlehem
    (Ornithogalum umbellatum)    		Softens impact of shock
  • Use

    • for relief of occasional sleeplessness caused by stress and repetitive thoughts
  • Warnings

    When using this product keep away from eyes

    Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults: apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed.
    • children under 12: ask a doctor
  • Other information

    • store below 77ºF (25ºC )
    • active ingredients made according to the Homeopathic Pharmacopoeia of the United States (HPUS)
  • Inactive ingredient

    alcohol

  • Questions?

    call 1-800-319-9151
    Mon-Fri 8am-5pm (EST)

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Nelson Bach USA Ltd.
    21 High Street, Suite 302
    N. Andover, MA 01845

  • PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

    RESCUE

    NDC #57687-242-20

    Bach®
    ORIGINAL
    FLOWER REMEDIES

    RESCUE
    SLEEP®*

    NATURAL
    SLEEP
    AID†

    0.7 fl oz (20mL)
    SPRAY

    Homeopathic
    Alcohol 27%

    *See disclaimer
    on back panel

    PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    RESCUE SLEEP 
    helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]  in 0.095 mL
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER5 [hp_X]  in 0.095 mL
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER5 [hp_X]  in 0.095 mL
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER5 [hp_X]  in 0.095 mL
    ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM WHOLE - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM WHOLE5 [hp_X]  in 0.095 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER5 [hp_X]  in 0.095 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-242-071 in 1 CARTON04/21/2006
    17 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:57687-242-201 in 1 CARTON05/17/2016
    220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/21/2006
    Labeler - Nelson Bach USA, Ltd. (877720193)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co. Limited221471234MANUFACTURE(57687-242) , PACK(57687-242) , LABEL(57687-242) , ANALYSIS(57687-242)
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