Incontinence

Aloe, Arg. Nit., Arsenicum Alb., Belladonna, Benzoicum Acidum, Bryonia, Cantharis, Causticum, Equisetum Hyemale, Ferrum Metallicum, Gelsemium, Ignatia, Kali Phos., Lycopodium, Nat. Mur., Nitricum Ac., Plantago, Pulsatilla, Rhus Aromatica , Sabal, Secale, Sepia, Staphysag.,stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis

Newton Laboratories, Inc.
Human Otc Drug
NDC 55714-4748

Incontinence also known as Aloe, Arg. Nit., Arsenicum Alb., Belladonna, Benzoicum Acidum, Bryonia, Cantharis, Causticum, Equisetum Hyemale, Ferrum Metallicum, Gelsemium, Ignatia, Kali Phos., Lycopodium, Nat. Mur., Nitricum Ac., Plantago, Pulsatilla, Rhus Aromatica , Sabal, Secale, Sepia, Staphysag.,stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis is a human otc drug labeled by 'Newton Laboratories, Inc.'. National Drug Code (NDC) number for Incontinence is 55714-4748. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Incontinence drug includes Aloe - 15 [hp_X]/mL Anemone Pulsatilla - 15 [hp_X]/mL Arsenic Trioxide - 15 [hp_X]/mL Atropa Belladonna - 15 [hp_X]/mL Benzoic Acid - 15 [hp_X]/mL Bryonia Alba Root - 15 [hp_X]/mL Causticum - 15 [hp_X]/mL Claviceps Purpurea Sclerotium - 15 [hp_X]/mL Datura Stramonium - 15 [hp_X]/mL Delphinium Staphisagria Seed - 15 [hp_X]/mL and more. The currest status of Incontinence drug is Active.

Drug Information:

Drug NDC:	55714-4748
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:	Incontinence
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:	Aloe, Arg. Nit., Arsenicum Alb., Belladonna, Benzoicum Acidum, Bryonia, Cantharis, Causticum, Equisetum Hyemale, Ferrum Metallicum, Gelsemium, Ignatia, Kali Phos., Lycopodium, Nat. Mur., Nitricum Ac., Plantago, Pulsatilla, Rhus Aromatica , Sabal, Secale, Sepia, Staphysag.,stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Newton Laboratories, 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:	ALOE - 15 [hp_X]/mL ANEMONE PULSATILLA - 15 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL ATROPA BELLADONNA - 15 [hp_X]/mL BENZOIC ACID - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CAUSTICUM - 15 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM - 15 [hp_X]/mL DATURA STRAMONIUM - 15 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED - 15 [hp_X]/mL Load more... ECHINACEA, UNSPECIFIED - 6 [hp_X]/mL EQUISETUM HYEMALE - 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/mL GOLDENSEAL - 6 [hp_X]/mL IRON - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL LYTTA VESICATORIA - 15 [hp_X]/mL NITRIC ACID - 15 [hp_X]/mL PLANTAGO MAJOR - 15 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC - 15 [hp_X]/mL RHUS AROMATICA ROOT BARK - 15 [hp_X]/mL SAW PALMETTO - 15 [hp_X]/mL SEPIA OFFICINALIS JUICE - 15 [hp_X]/mL SILVER NITRATE - 15 [hp_X]/mL SODIUM CHLORIDE - 15 [hp_X]/mL STRYCHNOS IGNATII SEED - 15 [hp_X]/mL THYROID, UNSPECIFIED - 15 [hp_X]/mL VERBASCUM THAPSUS - 15 [hp_X]/mL
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:	02 Sep, 2019
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:	Newton Laboratories, 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:	N0000175806 N0000175807
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	V5VD430YW9 I76KB35JEV S7V92P67HO WQZ3G9PF0H 8SKN0B0MIM T7J046YI2B DD5FO1WKFU 01G9XEA93N G6W4F0V8Z3 00543AP1JV Load more... 4N9P6CC1DX 59677RXH25 639KR60Q1Q ZW3Z11D0JV E1UOL152H7 C88X29Y479 3Q034RO3BT 411VRN1TV4 W2469WNO6U CI71S98N1Z Q3H36W0J42 J7WWH9M8QS QDL83WN8C2 95IT3W8JZE 451W47IQ8X 1NM3M2487K 0B4FDL9I6P C9TD27U172
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 MOA:	Ammonium Ion Binding Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Nitrogen Binding Agent [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:	Ammonium Ion Binding Activity [MoA] Nitrogen Binding Agent [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55714-4748-1	30 mL in 1 BOTTLE, GLASS (55714-4748-1)	02 Sep, 2019	N/A	No
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.

Other medicines with the same generic name

Incontinence

Aloe & more..

Liquid
Newton Laboratories, Inc.
NDC: 55714-4748

Incontinence

Aloe & more..

Pellet
Newton Laboratories, Inc.
NDC: 55714-2464

Incontinence

Aloe & more..

Liquid
Newton Laboratories, Inc.
NDC: 55714-2463

Purpose:

Otc - purpose section formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.

Product Elements:

Incontinence aloe, arg. nit., arsenicum alb., belladonna, benzoicum acidum, bryonia, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, ignatia, kali phos., lycopodium, nat. mur., nitricum ac., plantago, pulsatilla, rhus aromatica , sabal, secale, sepia, staphysag.,stramonium, thyroidinum, verbascum, echinacea, hydrastis alcohol aloe aloe silver nitrate silver cation arsenic trioxide arsenic cation (3+) atropa belladonna atropa belladonna benzoic acid benzoic acid bryonia alba root bryonia alba root lytta vesicatoria lytta vesicatoria causticum causticum equisetum hyemale equisetum hyemale iron iron gelsemium sempervirens root gelsemium sempervirens root strychnos ignatii seed strychnos ignatii seed potassium phosphate, dibasic phosphate ion lycopodium clavatum spore lycopodium clavatum spore sodium chloride chloride ion nitric acid nitric acid plantago major plantago major anemone pulsatilla anemone pulsatilla rhus aromatica root bark rhus aromatica root bark saw palmetto saw palmetto claviceps purpurea sclerotium claviceps purpurea sclerotium sepia officinalis juice sepia officinalis juice delphinium staphisagria seed delphinium staphisagria seed datura stramonium datura stramonium thyroid, unspecified thyroid, unspecified verbascum thapsus verbascum thapsus echinacea, unspecified echinacea, unspecified goldenseal goldenseal water

Indications and Usage:

Indications & usage section formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.

Warnings:

Warnings section warnings: keep out of reach of children. do not use if tamper-evident seal is broken or missing. if symptoms worsen or persist for more than a few days, consult a doctor. if pregnant or breast-feeding , ask a doctor before use

Dosage and Administration:

Dosage & administration section directions: ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

Package Label Principal Display Panel:

Package label package label

Further Questions:

Questions section www.newtonlabs.net newton laboratories, inc. fda est # 1051203 - conyers, ga 30012 questions? 1.800.448.7256

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.