NDC 55714-4468 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 55714-4468
NDC Code: 55714-4468
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.
- 55714-4468 - Acne Cystic Acne
NDC 55714-4468-1
Package Description: 29.57 mL in 1 BOTTLE, GLASS
NDC Product Information
Acne Cystic Acne with NDC 55714-4468 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 liquid and is administered via oral form.
Labeler Name: Newton Laboratories, Inc.
Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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]/mL
- ARSENIC TRIOXIDE 15 [hp_X]/mL
- GOLD 15 [hp_X]/mL
- MAHONIA AQUIFOLIUM ROOT BARK 15 [hp_X]/mL
- GIANT PUFFBALL 15 [hp_X]/mL
- ACTIVATED CHARCOAL 15 [hp_X]/mL
- CAUSTICUM 15 [hp_X]/mL
- CHELIDONIUM MAJUS 15 [hp_X]/mL
- SOLANUM DULCAMARA TOP 15 [hp_X]/mL
- GRAPHITE 15 [hp_X]/mL
- CALCIUM SULFIDE 15 [hp_X]/mL
- CENTELLA ASIATICA 15 [hp_X]/mL
- POTASSIUM BROMIDE 15 [hp_X]/mL
- POTASSIUM IODIDE 15 [hp_X]/mL
- LEDUM PALUSTRE TWIG 15 [hp_X]/mL
- LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
- STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL
- SILICON DIOXIDE 15 [hp_X]/mL
- SULFUR IODIDE 15 [hp_X]/mL
- ZINC 15 [hp_X]/mL
- ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
- ENGLISH WALNUT 3 [hp_X]/mL
- ARCTIUM LAPPA ROOT 3 [hp_X]/mL
- TARAXACUM OFFICINALE 3 [hp_X]/mL
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.
- Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
- Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Calcium - [CS]
- Cations -
- Divalent - [CS]
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Osmotic Activity - [MoA] (Mechanism of Action)
- 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]
- 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]
- 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: 12-31-2018 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: E 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
- Product Name & Indications Section
- Direction Section
- Active Ingredient Section
- Purpose Section
- Inactive Ingredient Section
- Questions? Section
- Warnings Section
- Pregnancy Or Breast Feeding Section
- Keep Out Of Reach Of Children Section
Product Name & Indications Section
ACNE~CYSTIC ACNE Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.
Direction Section
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.
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: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
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.