Skin Irritations And Itch Relief

Agaricus Muscarius, Alumina, Anagallis Arvensis, Antimonium Tartaricum, Apis Mellifica, Arsenicum Album, Arsenicum Iodatum, Bovista, Causticum, Dolichos Pruriens, Fagopyrum Esculentum, Graphites, Kali Muriaticum, Muriaticum Acidum, Oleander, Petroleum, Pix Liquida, Radium Bromatum, Rhus Toxicodendron, Selenium Metallicum, Sulphur, Urtica Urens.


King Bio Inc.
Human Otc Drug
NDC 57955-2817
Skin Irritations And Itch Relief also known as Agaricus Muscarius, Alumina, Anagallis Arvensis, Antimonium Tartaricum, Apis Mellifica, Arsenicum Album, Arsenicum Iodatum, Bovista, Causticum, Dolichos Pruriens, Fagopyrum Esculentum, Graphites, Kali Muriaticum, Muriaticum Acidum, Oleander, Petroleum, Pix Liquida, Radium Bromatum, Rhus Toxicodendron, Selenium Metallicum, Sulphur, Urtica Urens. is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Skin Irritations And Itch Relief is 57955-2817. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Skin Irritations And Itch Relief drug includes Aluminum Oxide - 10 [hp_X]/59mL Amanita Muscaria Fruiting Body - 10 [hp_X]/59mL Antimony Potassium Tartrate - 10 [hp_X]/59mL Apis Mellifera - 10 [hp_X]/59mL Arsenic Triiodide - 10 [hp_X]/59mL Arsenic Trioxide - 10 [hp_X]/59mL Causticum - 10 [hp_X]/59mL Fagopyrum Esculentum Whole - 10 [hp_X]/59mL Graphite - 10 [hp_X]/59mL Hydrochloric Acid - 10 [hp_X]/59mL and more. The currest status of Skin Irritations And Itch Relief drug is Active.

Drug Information:

Drug NDC: 57955-2817
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: Skin Irritations And Itch 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: Agaricus Muscarius, Alumina, Anagallis Arvensis, Antimonium Tartaricum, Apis Mellifica, Arsenicum Album, Arsenicum Iodatum, Bovista, Causticum, Dolichos Pruriens, Fagopyrum Esculentum, Graphites, Kali Muriaticum, Muriaticum Acidum, Oleander, Petroleum, Pix Liquida, Radium Bromatum, Rhus Toxicodendron, Selenium Metallicum, Sulphur, Urtica Urens.
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:ALUMINUM OXIDE - 10 [hp_X]/59mL
AMANITA MUSCARIA FRUITING BODY - 10 [hp_X]/59mL
ANTIMONY POTASSIUM TARTRATE - 10 [hp_X]/59mL
APIS MELLIFERA - 10 [hp_X]/59mL
ARSENIC TRIIODIDE - 10 [hp_X]/59mL
ARSENIC TRIOXIDE - 10 [hp_X]/59mL
CAUSTICUM - 10 [hp_X]/59mL
FAGOPYRUM ESCULENTUM WHOLE - 10 [hp_X]/59mL
GRAPHITE - 10 [hp_X]/59mL
HYDROCHLORIC ACID - 10 [hp_X]/59mL
KEROSENE - 10 [hp_X]/59mL
LYCOPERDON UTRIFORME FRUITING BODY - 10 [hp_X]/59mL
LYSIMACHIA ARVENSIS WHOLE - 10 [hp_X]/59mL
MUCUNA PRURIENS FRUIT TRICHOME - 10 [hp_X]/59mL
NERIUM OLEANDER LEAF - 10 [hp_X]/59mL
PINE TAR - 10 [hp_X]/59mL
POTASSIUM CHLORIDE - 10 [hp_X]/59mL
RADIUM BROMIDE - 12 [hp_X]/59mL
SELENIUM - 10 [hp_X]/59mL
SULFUR - 10 [hp_X]/59mL
TOXICODENDRON PUBESCENS LEAF - 10 [hp_X]/59mL
URTICA URENS WHOLE - 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: 07 Dec, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 Dec, 2025
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.
NUI:N0000185021
N0000175629
N0000184306
N0000185001
M0000728
M0002274
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:LMI26O6933
DIF093I037
DL6OZ476V3
7S82P3R43Z
3029988O2T
S7V92P67HO
DD5FO1WKFU
B10M69172N
4QQN74LH4O
QTT17582CB
1C89KKC04E
K2A74U428F
46883LR90E
3E271BSI0C
7KV510R6H6
YFH4WC535J
660YQ98I10
R74O7T8569
H6241UJ22B
70FD1KFU70
6IO182RP7A
IHN2NQ5OF9
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.
Pharmacologic Class EPC:Standardized Insect Venom Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Allergens [CS]
Bee Venoms [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Bee Venoms [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
Standardized Insect Venom Allergenic Extract [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
57955-2817-21 BOTTLE, SPRAY in 1 CARTON (57955-2817-2) / 59 mL in 1 BOTTLE, SPRAY07 Dec, 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:

Active ingredients purpose † equal volumes of each hpus** ingredient in 10x, 30x, and 1lm potencies, unless otherwise noted. agaricus muscarius ...................................................itching skin alumina .....................................................chapped, itching skin anagallis arvensis .........................................itching, tingling skin antimonium tartaricum .........................................itching pimples apis mellifica ..............................................stinging pains on skin arsenicum album.........................................dry, rough, scaly skin arsenicum iodatum......................................dry, scaly, itching skin bovista............................................................................eczema causticum .........................................................raw, burning skin dolichos pruriens..........................................intense itching of skin fagopyrum esculentum.............................sore, red blotches on skin graphites..............................................................rawness of skin kali muriaticum........................................................scales on skin muriaticum acidum ......................................skin eruptions, itching oleander...................................................soreness, chapping skin petroleum ......................................................itching skin at night pix liquida ....................................................cracked, itching skin radium bromatum (12x, 30x, & 1lm potencies)........................ .................................................................all over itching of skin rhus toxicodendron .....................................intense itching of skin selenium metallicum .......................................itching folds of skin sulphur..........................................................itching, burning skin urtica urens ................................................. stinging, itching skin **“hpus” indicates the active ingredients are in the official homeopathic pharmacopeia of the united states. reference image:skin irritations.jpg

Product Elements:

Skin irritations and itch relief agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum album, arsenicum iodatum, bovista, causticum, dolichos pruriens, fagopyrum esculentum, graphites, kali muriaticum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens. amanita muscaria fruiting body amanita muscaria fruiting body aluminum oxide aluminum oxide lysimachia arvensis whole anagallis arvensis extract antimony potassium tartrate antimony cation (3+) apis mellifera apis mellifera arsenic trioxide arsenic cation (3+) arsenic triiodide arsenic cation (3+) lycoperdon utriforme fruiting body lycoperdon utriforme fruiting body causticum causticum mucuna pruriens fruit trichome mucuna pruriens fruit trichome fagopyrum esculentum whole fagopyrum esculentum graphite graphite potassium chloride potassium cation hydrochloric acid hydrochloric acid nerium oleander leaf nerium oleander leaf kerosene kerosene pine tar pine tar radium bromide radium cation toxicodendron pubescens leaf toxicodendron pubescens leaf selenium selenium sulfur sulfur urtica urens whole urtica urens 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 uses for symptomatic relief of irritated skin, such as: itching rash hives redness burning sensitivity dryness scales dryness roughness 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:skin irritations.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:skin irritations.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:skin irritations.jpg

Package Label Principal Display Panel:

Image description skin irritations.jpg


Comments/ Reviews:

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