Label: RESTLESS LEG SYMPTOM RELIEF- natural medicine liquid

  • 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 December 20, 2011

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  • Active Ingredients

    Official HPUS: Arsenicum Album, Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Ledum Palustre, Pulsatilla, Rhus Toxicodendron, Sulphur, Tarentula Hispana, Viscum Album and Zincum Metallicum.

    Reference Image restless leg.jpg

  • Inactive Ingredients

    Bio-Energetically Enhanced pure water base 10X, 30X and LM1.

    Reference image restless leg.jpg

  • Dosage and Administration

    Directions: Initially depress pump until primed.  Hold close to mouth and spray one dose directly into mouth.  Use 3 times per day.  Use additionally as needed.

    Adult Dose: 3 pump sprays

    Children: (2-12 years) 2 pump sprays

    Reference image restless leg.jpg

  • Purpose

    Use as a natural aid for leg discomforts: restless legs-a compelling urge to move the legs, often worse at night.

    • cramping, burning, pain, uneasiness
    • twitching, drawing and jerking movements
    • legs feel heavy, numb, stiff or weak
    Reference image restless leg.jpg
  • WARNINGS

    If Symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional.

    Tamper  resistant for your protection, Use only if safety seal is intact.

    Reference image restless leg.jpg


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Reference image restless leg.jpg

  • Indications and Usage

    Use as a natural aid for leg discomforts: restless legs-a compelling urge to move the legs, often worse at night. Also use for cramping, burning, pain, uneasiness, twitching, drawing and jerking movements, legs feel heavy, numb, stiff or weak.

    Reference image restless leg.jpg
  • PRINCIPAL DISPLAY PANEL

    Image of label


    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    Questions? Call 800.543.3245

    www.kingbio.com

  • INGREDIENTS AND APPEARANCE
    RESTLESS LEG SYMPTOM RELIEF 
    natural medicine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-6235
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND10 [hp_X]  in 59 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM10 [hp_X]  in 59 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS10 [hp_X]  in 59 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 59 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA10 [hp_X]  in 59 mL
    VISCUM ALBUM FRUIT (UNII: P83EQ521R3) (VISCUM ALBUM FRUIT - UNII:P83EQ521R3) VISCUM ALBUM FRUIT10 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-6235-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/14/2011
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture
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