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


King Bio Inc.
Human Otc Drug
NDC 57955-2833
Restless Leg Symptom Relief also known as Arsenicum Album, Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla, Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Restless Leg Symptom Relief is 57955-2833. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Restless Leg Symptom Relief drug includes Arsenic Trioxide - 10 [hp_X]/59mL Bufo Bufo Cutaneous Gland - 10 [hp_X]/59mL Causticum - 10 [hp_X]/59mL Crotalus Horridus Horridus Venom - 10 [hp_X]/59mL Digitalis - 10 [hp_X]/59mL Lachesis Muta Venom - 10 [hp_X]/59mL Lilium Lancifolium Whole Flowering - 10 [hp_X]/59mL Lycosa Tarantula - 10 [hp_X]/59mL Matricaria Chamomilla Whole - 10 [hp_X]/59mL Pulsatilla Vulgaris Whole - 10 [hp_X]/59mL and more. The currest status of Restless Leg Symptom Relief drug is Active.

Drug Information:

Drug NDC: 57955-2833
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Restless Leg Symptom Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Arsenicum Album, Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla, Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: King Bio Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ARSENIC TRIOXIDE - 10 [hp_X]/59mL
BUFO BUFO CUTANEOUS GLAND - 10 [hp_X]/59mL
CAUSTICUM - 10 [hp_X]/59mL
CROTALUS HORRIDUS HORRIDUS VENOM - 10 [hp_X]/59mL
DIGITALIS - 10 [hp_X]/59mL
LACHESIS MUTA VENOM - 10 [hp_X]/59mL
LILIUM LANCIFOLIUM WHOLE FLOWERING - 10 [hp_X]/59mL
LYCOSA TARANTULA - 10 [hp_X]/59mL
MATRICARIA CHAMOMILLA WHOLE - 10 [hp_X]/59mL
PULSATILLA VULGARIS WHOLE - 10 [hp_X]/59mL
SULFUR - 10 [hp_X]/59mL
TOXICODENDRON PUBESCENS LEAF - 10 [hp_X]/59mL
VISCUM ALBUM FRUITING TOP - 10 [hp_X]/59mL
ZINC - 10 [hp_X]/59mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 22 Jul, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:King Bio Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:S7V92P67HO
Q59QU6N72Q
DD5FO1WKFU
YHA2XLJ956
F1T8QT9U8B
VSW71SS07I
X67Z2963PI
86M454L2TT
G0R4UBI2ZZ
I76KB35JEV
70FD1KFU70
6IO182RP7A
BK9092J5MP
J41CSQ7QDS
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
57955-2833-21 BOTTLE, SPRAY in 1 CARTON (57955-2833-2) / 59 mL in 1 BOTTLE, SPRAY22 Jul, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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

Product Elements:

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 arsenic trioxide arsenic cation (3+) bufo bufo cutaneous gland bufo bufo cutaneous gland causticum causticum matricaria chamomilla whole matricaria chamomilla crotalus horridus horridus venom crotalus horridus horridus venom digitalis digitalis lachesis muta venom lachesis muta venom lilium lancifolium whole flowering lilium lancifolium whole flowering pulsatilla vulgaris whole anemone pulsatilla toxicodendron pubescens leaf toxicodendron pubescens leaf sulfur sulfur lycosa tarantula lycosa tarantula viscum album fruiting top viscum album fruiting top zinc zinc ascorbic acid citric acid monohydrate citrus aurantium fruit oil orange peel citrus reticulata fruit oil water glycerin lactic acid, unspecified form lonicera japonica flower benzylpenicilloyl polylysine carya ovata bark steviol

Indications and Usage:

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:

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

Dosage and Administration:

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

Package Label Principal Display Panel:

Image description restless leg.jpg


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.