NDC 55714-4535 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

NDC Product Code 55714-4535

NDC Code: 55714-4535

Proprietary Name: Incontinence What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 55714-4535-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-4535-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Incontinence with NDC 55714-4535 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Incontinence is 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. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Incontinence Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALOE 20 [hp_X]/g
  • SILVER NITRATE 20 [hp_X]/g
  • ARSENIC TRIOXIDE 20 [hp_X]/g
  • ATROPA BELLADONNA 20 [hp_X]/g
  • BENZOIC ACID 20 [hp_X]/g
  • BRYONIA ALBA ROOT 20 [hp_X]/g
  • LYTTA VESICATORIA 20 [hp_X]/g
  • CAUSTICUM 20 [hp_X]/g
  • EQUISETUM HYEMALE 20 [hp_X]/g
  • IRON 20 [hp_X]/g
  • GELSEMIUM SEMPERVIRENS ROOT 20 [hp_X]/g
  • STRYCHNOS IGNATII SEED 20 [hp_X]/g
  • POTASSIUM PHOSPHATE, DIBASIC 20 [hp_X]/g
  • LYCOPODIUM CLAVATUM SPORE 20 [hp_X]/g
  • SODIUM CHLORIDE 20 [hp_X]/g
  • NITRIC ACID 20 [hp_X]/g
  • PLANTAGO MAJOR 20 [hp_X]/g
  • PULSATILLA VULGARIS 20 [hp_X]/g
  • RHUS AROMATICA ROOT BARK 20 [hp_X]/g
  • SAW PALMETTO 20 [hp_X]/g
  • CLAVICEPS PURPUREA SCLEROTIUM 20 [hp_X]/g
  • SEPIA OFFICINALIS JUICE 20 [hp_X]/g
  • DELPHINIUM STAPHISAGRIA SEED 20 [hp_X]/g
  • DATURA STRAMONIUM 20 [hp_X]/g
  • THYROID, UNSPECIFIED 20 [hp_X]/g
  • VERBASCUM THAPSUS 20 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 8 [hp_X]/g
  • GOLDENSEAL 8 [hp_X]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
  • Nitrogen Binding Agent - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Incontinence Product Label Images

Incontinence Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications & Usage Section

Incontinence   Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

Active Ingredient Section

Aloe 20x, Arg. nit. 20x, Arsenicum alb. 20x, Belladonna 20x, Benzoicum acidum 20x, Bryonia 20x, Cantharis 20x, Causticum 20x, Equisetum hyemale 20x, Ferrum metallicum 20x, Gelsemium 20x, Ignatia 20x, Kali phos. 20x, Lycopodium 20x, Nat. mur. 20x, Nitricum ac. 20x, Plantago 20x, Pulsatilla 20x, Rhus aromatica 20x, Sabal 20x, Secale 20x, Sepia 20x, Staphysag. 20x, Stramonium 20x, Thyroidinum 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.

Purpose Section

Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.

Inactive Ingredient Section

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.

Questions? Section

Www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children.

Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.

Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.