Label: RESTLESS LEG SYMPTOM RELIEF- arsenicum album, bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla, rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum 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 November 18, 2022

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

  • Directions

    Initially, depress pump until
    primed.

    Spray one dose directly into
    mouth.

    Adults: 3 sprays 3 times per
    day.

    Children ages 6-12: 2 sprays 3
    times per day.

    Consult a physician for use in
    children under 6 years of age.

    Use additionally as needed, up
    to 6 times per day.

    Reference image:Restless Leg.jpg

  • OTHER SAFETY INFORMATION

    Other information

    Tamper resistant for your protection.

    Use only if safety seal is intact.

    Keep carton for complete drug facts and product information.

    Questions? Call 866.298.2740

    King Bio, Inc. 3 Westside Drive

    Asheville, NC 2806 USA

    FDA Reg. #1053442

    For latest product information and instructions: www.DrKings.com

    Reference image:Restless Leg.jpg

  • Inactive Ingredients

    Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

    Reference image:Restless Leg.jpg

  • Active ingredients

    Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
    potencies.

    Arsenicum album, Bufo rana, Causticum, Chamomilla, Crotalus horridus, Digitalis purpurea, Lachesis mutus, Lilium tigrinum, Pulsatilla, Rhus tox, Sulphur, Tarentula hispana, Viscum album, Zincum metallicum.

    HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

    Reference image:Restless Leg.jpg

  • Uses

    For symptoms of restless legs, often worse at night:

    urge to move the legs 

    heaviness 

    muscle stiffness

    uneasiness in legs 

    leg cramps 

    burning sensation

    twitching, drawing, jerking legs

    as per various homeopathic materia medicas. Claims based
    on traditional homeopathic practice, not accepted medical
    evidence. These uses have not been evaluated by the FDA,
    and product has not been clinically tested.

    Reference image:Restless Leg.jpg

  • Warnings

    Stop use and consult a physician if symptoms worsen or
    persist for more than 7 days.

    If pregnant or breast-feeding, ask a healthcare professional
    before use.
    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Reference image:Restless Leg.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Reference image:Restless Leg.jpg 

  • PURPOSE

    Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
    potencies.

    Arsenicum album................... restlessness, spasms, leg cramps
    Bufo rana.................................................................stiffness
    Causticum ............................................. restless legs at night
    Chamomilla ................................................cramps, leg aches
    Crotalus horridus ..................................jerking leg movements
    Digitalis purpurea ...................................heavy feeling in limbs
    Lachesis mutus ...............................cramps, sciatic discomforts
    Lilium tigrinum .........................................aching, restless legs
    Pulsatilla ..........................drawing pain in legs with restlessness
    Rhus tox ..................................................,...muscular stiffness
    Sulphur..........................................burning sensation, heaviness
    Tarentula hispana ............... twitching, jerking, uneasiness in legs
    Viscum album......................back, hip and leg discomfort, worse
    when lying down
    Zincum metallicum ............ twitching, jerking movements at night


    **“HPUS” indicates the active ingredients are in the official
    Homeopathic Pharmacopeia of the United States.

    Reference image:Restless Leg.jpg

  • PRINCIPAL DISPLAY PANEL

    image description Restless Leg.jpg

  • INGREDIENTS AND APPEARANCE
    RESTLESS LEG SYMPTOM RELIEF 
    arsenicum album, bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla, rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2833
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) 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 CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE10 [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
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE10 [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 FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP10 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    STEVIOL (UNII: 4741LYX6RT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-2833-21 in 1 CARTON07/22/2022
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/22/2022
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2833) , api manufacture(57955-2833)