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

  • NDC Code(s): 57687-243-20
  • Packager: Nelson Bach USA Limited
  • 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 August 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Each 5× (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 breast-feeding, 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 and children age 2 and up: take 4 drops directly on the tongue or 4 drops in water and sip at intervals. Additional drops may be taken during the night as needed.
    • children under 2: ask a doctor
  • Other information

    • store below 77°F (25°C)
    • do not use if tamper evident seal is broken
    • active ingredients made according to the Homeopathic Pharmacopoeia of the United States (HPUS)
  • Inactive ingredients

    glycerin, purified water

  • Questions?

    Call 1-800-319-9151

    Mon-Fri 8am-5pm (EST)

  • SPL UNCLASSIFIED SECTION

    Dist. by Nelson Bach USA, Ltd.
    21 High St., #302, North Andover, MA 01845

  • PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

    RESCUE

    NDC #57687-243-20

    Bach®
    ORIGINAL
    FLOWER REMEDIES

    NEW

    RESCUE
    SLEEP®*
    DROPPER

    NATURAL
    SLEEP
    AID†

    ALCOHOL-FREE

    NON-HABIT
    FORMING

    0.7 fl oz
    (20mL)
    DROPPER

    *See disclaimer
    on back panel

    Homeopathic

    PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    RESCUE SLEEP   DROPPER
    helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum whole, and aesculus hippocastanum flower solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-243
    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
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-243-201 in 1 CARTON12/01/2020
    120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/01/2020
    Labeler - Nelson Bach USA Limited (877720193)
    Registrant - A. Nelson & Co. Limited (221471234)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co Ltd221471234MANUFACTURE(57687-243) , PACK(57687-243) , LABEL(57687-243) , ANALYSIS(57687-243)
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