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
- NDC Code(s): 57955-2833-2
- Packager: King Bio Inc.
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Directions
-
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
-
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
-
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-2833 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 10 [hp_X] in 59 mL BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND 10 [hp_X] in 59 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 59 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 10 [hp_X] in 59 mL CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM 10 [hp_X] in 59 mL DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS 10 [hp_X] in 59 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 10 [hp_X] in 59 mL LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING 10 [hp_X] in 59 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59 mL LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA 10 [hp_X] in 59 mL VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 10 [hp_X] in 59 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-2833-2 1 in 1 CARTON 07/22/2022 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/22/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-2833) , api manufacture(57955-2833)