NDC 55714-4469 Acne - Cystic Acne

Antimon. Crud., Arsenicum Alb., Aur. Met., Berber. Aqui., Bovista, Carbo Veg., Causticum, Chelidonium Majus, Dulcamara, Graphites, Hepar Sulph. Calc., Hydrocotyle, Kali Brom., Kali Iod., Ledum, Lycopodium, Nux Vom., Silicea, Sulphur Iod., Zinc. Met., Echinacea, Juglans Regia, Lappa, Taraxacum

NDC Product Code 55714-4469

NDC Code: 55714-4469

Proprietary Name: Acne - Cystic Acne 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: Antimon. Crud., Arsenicum Alb., Aur. Met., Berber. Aqui., Bovista, Carbo Veg., Causticum, Chelidonium Majus, Dulcamara, Graphites, Hepar Sulph. Calc., Hydrocotyle, Kali Brom., Kali Iod., Ledum, Lycopodium, Nux Vom., Silicea, Sulphur Iod., Zinc. Met., Echinacea, Juglans Regia, Lappa, Taraxacum 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-4469 - Acne - Cystic Acne

NDC 55714-4469-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-4469-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Acne - Cystic Acne with NDC 55714-4469 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Acne - Cystic Acne is antimon. crud., arsenicum alb., aur. met., berber. aqui., bovista, carbo veg., causticum, chelidonium majus, dulcamara, graphites, hepar sulph. calc., hydrocotyle, kali brom., kali iod., ledum, lycopodium, nux vom., silicea, sulphur iod., zinc. met., echinacea, juglans regia, lappa, taraxacum. 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.

Acne - Cystic Acne 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.

  • ANTIMONY TRISULFIDE 15 [hp_X]/g
  • ARSENIC TRIOXIDE 15 [hp_X]/g
  • GOLD 15 [hp_X]/g
  • MAHONIA AQUIFOLIUM ROOT BARK 15 [hp_X]/g
  • GIANT PUFFBALL 15 [hp_X]/g
  • ACTIVATED CHARCOAL 15 [hp_X]/g
  • CAUSTICUM 15 [hp_X]/g
  • CHELIDONIUM MAJUS 15 [hp_X]/g
  • SOLANUM DULCAMARA TOP 15 [hp_X]/g
  • GRAPHITE 15 [hp_X]/g
  • CALCIUM SULFIDE 15 [hp_X]/g
  • CENTELLA ASIATICA 15 [hp_X]/g
  • POTASSIUM BROMIDE 15 [hp_X]/g
  • POTASSIUM IODIDE 15 [hp_X]/g
  • LEDUM PALUSTRE TWIG 15 [hp_X]/g
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/g
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/g
  • SILICON DIOXIDE 15 [hp_X]/g
  • SULFUR IODIDE 15 [hp_X]/g
  • ZINC 15 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/g
  • ENGLISH WALNUT 3 [hp_X]/g
  • ARCTIUM LAPPA ROOT 3 [hp_X]/g
  • TARAXACUM OFFICINALE 3 [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.

  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Dietary Proteins - [CS]
  • Nut Proteins - [EXT]
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)

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.

Acne - Cystic Acne Product Label Images

Acne - Cystic Acne 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

ACNE - CYSTIC ACNE  Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets (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

Antimon. crud. 15x, Arsenicum alb.5x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x, Sulphur  iod. 15x, Zinc. met. 15x, Echinacea 3x, Juglans regia 3x, Lappa 3x, Taraxacum 3x.

Purpose Section

Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

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.

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